Trial Outcomes & Findings for Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC) (NCT NCT02771626)
NCT ID: NCT02771626
Last Updated: 2023-03-17
Results Overview
An adverse event (AE) is any untoward, undesired, or unplanned event that does not need to be causally related to treatment. A serious adverse event (SAE) is an AE that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in a persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, or important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based on appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Relatedness to study medication was graded as either, probably, possibly, unlikely, or unrelated. Events were categorized according to the Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
118 participants
Primary outcome timeframe
From the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Results posted on
2023-03-17
Participant Flow
Participant milestones
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic clear cell renal cell carcinoma (ccRCC), melanoma, and non-small cell lung cancer (NSCLC).
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one tyrosine kinase inhibitor (TKI) but are treatment naïve to checkpoint modulators programmed death-1/programmed death ligand-1 (PD-1/PD-L1), cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the epidermal growth factor receptor (EGFR) oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
26
|
17
|
9
|
37
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
26
|
17
|
9
|
37
|
21
|
Reasons for withdrawal
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic clear cell renal cell carcinoma (ccRCC), melanoma, and non-small cell lung cancer (NSCLC).
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one tyrosine kinase inhibitor (TKI) but are treatment naïve to checkpoint modulators programmed death-1/programmed death ligand-1 (PD-1/PD-L1), cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the epidermal growth factor receptor (EGFR) oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
3
|
0
|
1
|
1
|
|
Overall Study
Radiologic Disease Progression
|
6
|
13
|
10
|
7
|
28
|
15
|
|
Overall Study
Symptomatic Deterioration
|
0
|
4
|
2
|
0
|
5
|
2
|
|
Overall Study
Participant Request
|
0
|
1
|
0
|
2
|
0
|
1
|
|
Overall Study
Investigator Decision
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Study Termination by Sponsor
|
0
|
2
|
1
|
0
|
1
|
0
|
|
Overall Study
Informed Consent Withdrawn
|
0
|
0
|
1
|
0
|
1
|
1
|
|
Overall Study
Other, Not Specified
|
1
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
n=8 Participants
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
n=26 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
n=17 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
n=9 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
n=37 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
n=21 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 13.51 • n=99 Participants
|
58.4 years
STANDARD_DEVIATION 10.75 • n=107 Participants
|
67.8 years
STANDARD_DEVIATION 9.85 • n=206 Participants
|
63.2 years
STANDARD_DEVIATION 7.90 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 11.82 • n=31 Participants
|
67.0 years
STANDARD_DEVIATION 11.55 • n=30 Participants
|
63.3 years
STANDARD_DEVIATION 11.43 • n=3 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
42 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
76 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
108 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
101 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.An adverse event (AE) is any untoward, undesired, or unplanned event that does not need to be causally related to treatment. A serious adverse event (SAE) is an AE that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in a persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, or important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based on appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Relatedness to study medication was graded as either, probably, possibly, unlikely, or unrelated. Events were categorized according to the Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death.
Outcome measures
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
n=8 Participants
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
n=26 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
n=17 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
n=9 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
n=37 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
n=21 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 serious TEAE ≥ grade 3
|
1 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 serious TEAE related to nivolumab
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 serious TEAE related to telaglenastat
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 serious TEAE ≥ grade 3 related to nivolumab
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 serious TEAE ≥ grade 3 related to telaglenastat
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE
|
8 Participants
|
26 Participants
|
17 Participants
|
9 Participants
|
36 Participants
|
21 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE ≥ grade 3
|
5 Participants
|
17 Participants
|
8 Participants
|
4 Participants
|
17 Participants
|
12 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE related to nivolumab
|
6 Participants
|
22 Participants
|
15 Participants
|
8 Participants
|
28 Participants
|
17 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE related to telaglenastat
|
4 Participants
|
24 Participants
|
15 Participants
|
9 Participants
|
28 Participants
|
17 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE ≥ grade 3 related to nivolumab
|
0 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE ≥ grade 3 related to telaglenastat
|
0 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 grade 5 TEAE related to nivolumab
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 grade 5 TEAE related to telaglenastat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE leading to discontinuation (DC) of nivolumab
|
1 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE leading to DC of telaglenastat
|
0 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE leading to DC of nivolumab and telaglenastat
|
0 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE leading to DC of nivolumab or telaglenastat
|
1 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE requiring nivolumab dose interruption or reduction
|
4 Participants
|
15 Participants
|
10 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE requiring telaglenastat dose interruption or reduction
|
4 Participants
|
16 Participants
|
9 Participants
|
6 Participants
|
14 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE requiring nivolumab and telaglenastat dose interruption or reduction
|
3 Participants
|
15 Participants
|
9 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 TEAE requiring nivolumab or telaglenastat dose interruption or reduction
|
4 Participants
|
16 Participants
|
10 Participants
|
8 Participants
|
15 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 grade 5 TEAE
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
≥ 1 serious TEAE
|
2 Participants
|
7 Participants
|
6 Participants
|
1 Participants
|
9 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.Hematology assessments included: hemoglobin; hematocrit, red blood cell count, white blood cell count with differential, and platelet count. Serum chemistry panel included: sodium, potassium, chloride, carbon dioxide, calcium, glucose, blood urea nitrogen, total protein, albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, creatinine, thyroid stimulating hormone. Vital sign assessments included systolic and diastolic blood pressures, pulse (heart) rate, respiratory rate, temperature, and body weight.
Outcome measures
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
n=8 Participants
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
n=26 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
n=17 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
n=9 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
n=37 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
n=21 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight
Hematology Values
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight
Clinical Laboratory Values
|
1 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight
Vital Sign Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight
Weight
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to a maximum of 2.8 yearsORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR or PR was required to be sustained for 4 weeks when confirmation was reported. * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
n=8 Participants
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
n=26 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
n=17 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
n=9 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
n=37 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
n=21 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
0 percentage of participants
Interval 0.0 to 36.9
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
5.9 percentage of participants
Interval 0.1 to 28.7
|
0 percentage of participants
Interval 0.0 to 33.6
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
PRIMARY outcome
Timeframe: up to a maximum of 2.8 yearsPopulation: Participants with a response.
DOR is defined as the time between the first documentation of a PR or a CR to the first documentation of progressive disease (PD) or death, whichever occurred first. DOR was censored at the date of last radiographic disease if the patient was alive and progression free at the time of database lock, PD, or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol treatment prior to documentation of disease progression. * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
n=6 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
n=1 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
n=2 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Duration of Response (DOR) Per Investigator Assessed RECIST v1.1
|
—
|
13.01 months
Interval 11.01 to
Upper limit of confidence interval not available due to insufficient events above the median.
|
3.71 months
Not applicable since 1 participant analyzed.
|
—
|
9.59 months
Interval 4.53 to 14.65
|
—
|
SECONDARY outcome
Timeframe: up to a maximum of 2.8 yearsPopulation: Participants with an event (PD per RECIST v1.1 or death from any cause).
PFS was defined as time from the first dose date to the earlier of either PD per RECIST v1.1 or death from any cause. The duration of PFS was censored at the date of last radiographic disease if the patient was alive and progression-free at the time of analysis data cutoff, disease progression, or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol treatment prior to documentation of disease progression. \- PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
n=8 Participants
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
n=18 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
n=14 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
n=7 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
n=32 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
n=17 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) Per RECIST v1.1
|
3.42 months
Interval 1.74 to 9.33
|
3.72 months
Interval 1.84 to 12.85
|
3.71 months
Interval 1.87 to 5.52
|
1.87 months
Interval 1.81 to 5.52
|
2.07 months
Interval 1.87 to 3.75
|
2.20 months
Interval 1.74 to 5.59
|
SECONDARY outcome
Timeframe: up to a maximum of 2.8 yearsOverall survival was defined as the time from the first dose date to death due to any cause. For participants alive at time of analysis, overall survival was censored at the time when the participant was last known to be alive.
Outcome measures
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
n=8 Participants
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
n=26 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
n=17 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
n=9 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
n=37 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
n=21 Participants
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
NA months
Interval 8.25 to
Insufficient events to establish the median and upper confidence limit.
|
24.54 months
Interval 16.3 to
Upper limit of confidence interval not available due to insufficient events above the median.
|
22.57 months
Interval 14.62 to
Upper limit of confidence interval not available due to insufficient events above the median.
|
NA months
Interval 26.25 to
Insufficient events to establish the median and upper confidence limit.
|
10.91 months
Interval 8.87 to 18.14
|
8.61 months
Interval 4.11 to 19.71
|
Adverse Events
Telaglenastat 600 mg + Standard Dose Nivolumab
Serious events: 2 serious events
Other events: 8 other events
Deaths: 3 deaths
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
Serious events: 8 serious events
Other events: 26 other events
Deaths: 15 deaths
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
Serious events: 6 serious events
Other events: 15 other events
Deaths: 11 deaths
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
Serious events: 1 serious events
Other events: 9 other events
Deaths: 3 deaths
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
Serious events: 12 serious events
Other events: 36 other events
Deaths: 27 deaths
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Serious events: 7 serious events
Other events: 21 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
n=8 participants at risk
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
n=26 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
n=17 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
n=9 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
n=37 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
n=21 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Infections and infestations
Septic shock
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
General disorders
Disease progression
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.4%
2/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.4%
2/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Immune system disorders
Immune system disorder
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
Other adverse events
| Measure |
Telaglenastat 600 mg + Standard Dose Nivolumab
n=8 participants at risk
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
n=26 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
n=17 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
n=9 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
n=37 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
|
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
n=21 participants at risk
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
15.4%
4/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
18.9%
7/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
4/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
15.4%
4/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.5%
4/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
21.6%
8/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
10.8%
4/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.0%
4/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
15.4%
4/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
26.9%
7/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
35.3%
6/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
55.6%
5/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
43.2%
16/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
42.9%
9/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.2%
5/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
29.4%
5/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
44.4%
4/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
16.2%
6/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
38.1%
8/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
34.6%
9/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
33.3%
3/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
16.2%
6/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.0%
4/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
15.4%
4/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
16.2%
6/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
33.3%
7/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
26.9%
7/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
21.6%
8/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
14.3%
3/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
33.3%
3/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
13.5%
5/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
10.8%
4/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.4%
2/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.1%
6/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
41.2%
7/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
33.3%
3/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
16.2%
6/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.0%
4/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.2%
5/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.5%
4/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
16.2%
6/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
13.5%
5/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.4%
2/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
10.8%
4/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
General disorders
Fatigue
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
53.8%
14/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
47.1%
8/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
66.7%
6/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
32.4%
12/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
38.1%
8/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
General disorders
Oedema peripheral
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.1%
6/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
General disorders
Pain
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
26.9%
7/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
General disorders
Chills
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
General disorders
Arthralgia
|
50.0%
4/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
26.9%
7/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
13.5%
5/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.2%
5/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
10.8%
4/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.0%
4/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
14.3%
3/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.4%
2/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
14.3%
3/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.2%
5/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.5%
4/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
29.7%
11/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
14.3%
3/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
30.8%
8/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.5%
4/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
18.9%
7/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Investigations
Blood creatinine increased
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.2%
5/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.5%
4/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
17.6%
3/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.5%
4/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Investigations
Weight decreased
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
4/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
30.8%
8/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.5%
4/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
44.4%
4/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
28.6%
6/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
15.4%
4/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.5%
4/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
33.3%
3/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.4%
2/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.8%
5/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.0%
4/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Eye disorders
Photophobia
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
46.2%
12/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.5%
4/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
33.3%
3/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
32.4%
12/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
28.6%
6/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Eye disorders
Vision blurred
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
23.1%
6/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Eye disorders
Visual impairment
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
4/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
26.9%
7/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
29.4%
5/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
44.4%
4/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
10.8%
4/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.0%
4/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
2/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
26.9%
7/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
8.1%
3/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
14.3%
3/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.2%
5/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.2%
5/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
15.4%
4/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
9.5%
2/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.2%
5/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
29.4%
5/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
22.2%
2/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
13.5%
5/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
14.3%
3/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.2%
5/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
10.8%
4/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
14.3%
3/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
3.8%
1/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
13.5%
5/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
7.7%
2/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.4%
2/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.8%
2/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
2.7%
1/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
19.0%
4/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.5%
3/26 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
5.9%
1/17 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
11.1%
1/9 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
0.00%
0/37 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
4.8%
1/21 • All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Per protocol, serious adverse events exclude those of Grade 5 disease progression.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication by the PI before either a multi-site publication or 18 months after final multi-site study report. PI can only publish their own results and provide 45 days in advance notice. PI must delete any Calithera confidential information from the publication other than study results and give good faith consideration to other comments made by Calithera. The PI must delay the publication for up to 45 days if requested by Calithera and publicly acknowledge Calithera and Pfizer support.
- Publication restrictions are in place
Restriction type: OTHER