Trial Outcomes & Findings for Pembrolizumab With Liver-Directed or Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumors and Liver Metastases (NCT NCT03457948)
NCT ID: NCT03457948
Last Updated: 2026-08-28
Results Overview
The All Subjects as Treated (ASaT, ITT) population will be used for the analysis of ORR. The primary efficacy endpoint will be best observed Overall Response Rate (ORR) by RECIST 1.1 (investigator reported). ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). The proportion of participants with a response and 90% confidence interval of overall response rate will be obtained for each of the three groups separately.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Up to 25 months
Results posted on
2026-08-28
Participant Flow
Participant milestones
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
3
|
3
|
|
Overall Study
COMPLETED
|
26
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab With Liver-Directed or Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumors and Liver Metastases
Baseline characteristics by cohort
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
n=26 Participants
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
n=3 Participants
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
n=3 Participants
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
40 - 49 years old
|
4 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
5 Participants
n=29 Participants
|
|
Age, Customized
20 - 29 years old
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
1 Participants
n=29 Participants
|
|
Age, Customized
30 - 39 years old
|
1 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
2 Participants
n=29 Participants
|
|
Age, Customized
50 - 59 years old
|
7 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
8 Participants
n=29 Participants
|
|
Age, Customized
60 - 69 years old
|
6 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
7 Participants
n=29 Participants
|
|
Age, Customized
70 -79 years old
|
7 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
9 Participants
n=29 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
15 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
17 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
5 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
1 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
21 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
1 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
4 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
2 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
29 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
1 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
32 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: Up to 25 monthsThe All Subjects as Treated (ASaT, ITT) population will be used for the analysis of ORR. The primary efficacy endpoint will be best observed Overall Response Rate (ORR) by RECIST 1.1 (investigator reported). ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). The proportion of participants with a response and 90% confidence interval of overall response rate will be obtained for each of the three groups separately.
Outcome measures
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
n=26 Participants
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
n=3 Participants
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
n=3 Participants
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
|---|---|---|---|
|
Proportion of Participants With an Overall Response
|
0.35 proportion of participants
Interval 0.2 to 0.52
|
0 proportion of participants
Interval 0.0 to 0.63
|
0 proportion of participants
Interval 0.0 to 0.63
|
PRIMARY outcome
Timeframe: Up to 30 days after the end of treatment, approximately 26 monthsAdverse events occurring from the start of the treatment regimen until 30 days after the end of treatment will be summarized by number of participants reporting under maximum toxicity grade for participants enrolled in Group 1. All treatment-related adverse events will be graded using NCI CTCAE v5.0.
Outcome measures
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
n=26 Participants
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Alanine aminotransferase increased
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Anorexia
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Creatinine increased
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Dysgeusia
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Fatigue
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grae 2 Adrenal insufficiency
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Anxiety
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Arthralgia
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Blurred vision
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Nausea
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Hypothyroidsim
|
4 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Rash maculo-papular
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 3 Neutrophil count decreased
|
2 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 3 Platelet count decreased
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 3 Small intestinal obstruction
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 3 White blood cell decreased
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Abdominal Pain
|
2 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Acidosis
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 4 Hyponatremia
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 3 Anemia
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 3 Colitis
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 3 Hyperglycemia
|
2 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 3 Hypokalemia
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 3 Lymphocyte count decreased
|
2 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 2 Vomiting
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Alopecia
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Aspartate aminotransferase increased
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Back Pain
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Blood bilirubin increased
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Bone Pain
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Bruising
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Diarrhea
|
4 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Dry Skin
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Edema limbs
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Fever
|
2 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Flu like symptoms
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Memory impairment
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Muscle weakness lower limb
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Muscle weakness trunk
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Myalgia
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Pruritus
|
8 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Peripheral sensory neuropathy
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Group 1)
Grade 1 Skin hypopigmentation
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Only participants with response were assessed. No participants in group II and group III demonstrated a response
Kaplan-Meier method will be used to summarize DOR for participants with a documented complete response or partial response per RECIST v.1.1 criteria. . Median DOR and its 95% confidence interval will be obtained for each of the three liver-directed therapies and PRRT groups separately.
Outcome measures
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
n=26 Participants
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
|---|---|---|---|
|
Median Duration of Response (DOR)
|
9.6 months
Interval 2.7 to 18.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after the end of treatment, approximately 26 monthsAdverse events occurring from the start of the treatment regimen until 30 days after the end of treatment will be summarized by number of participants reporting under the maximum toxicity grade for participants enrolled in Groups 2 and 3. All treatment-related adverse events will be graded using NCI CTCAE v5.0.
Outcome measures
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
n=3 Participants
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
n=3 Participants
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 2-Alkaline phosphatase increased
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 2-Anorexia
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 3-Aspartate aminotransferase increased
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1-Vomiting
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 2-Abdominal Pain
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 2-Alanine aminotransferase increased
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1-Anemia
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 2-Bloating
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 2-Blood bilirubin increased
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1 Brusing
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 2-Dyspnea
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 3-Fatigue
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1-Fever
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1-Hyperthyroidism
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1-Hyponatremia
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 2 Hypothyroidism
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1-INR Increased
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1-Myalgia
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1-Nausea
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 2-Pain
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 1-Platelet count decreased
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-related Adverse Events by Maximum Grade (Groups 2 & 3)
Grade 3-Pneumonitis
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsProgression free survival is defined as the time from the first day of study treatment with protocol therapy to the date of documented tumor progression or death due to any cause, whichever occurs first, as determined by RECIST v1.1. Kaplan-Meier methods will be used to estimate PFS with 95% confidence interval for each group separately.
Outcome measures
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
n=26 Participants
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
n=3 Participants
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
n=3 Participants
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
|---|---|---|---|
|
Median Progression Free Survival (PFS)
|
13.3 months
Interval 8.4 to 18.4
|
8 months
There were insufficient number of events so an upper and lower confidence interval could not be calculated.
|
2 months
There were insufficient number of events so an upper and lower confidence interval could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 3 yearsImmune-related progression free survival is defined as the time from the first day of study treatment with protocol therapy to the date of documented tumor progression or death due to any cause, whichever occurs first, as determined by immune-related-RECIST (irRC). Kaplan-Meier methods will be used to estimate irPFS with 95% confidence interval for each group separately.
Outcome measures
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
n=26 Participants
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
n=3 Participants
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
n=3 Participants
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
|---|---|---|---|
|
Immune-related Progression Free Survival (irPFS)
|
13.3 months
Interval 8.4 to 18.4
|
8 months
There were insufficient number of events so an upper and lower confidence interval could not be calculated.
|
2 months
There were insufficient number of events so an upper and lower confidence interval could not be calculated.
|
Adverse Events
Group I [Pembrolizumab, 177Lu DOTATATE]
Serious events: 14 serious events
Other events: 26 other events
Deaths: 4 deaths
Group II [Pembrolizumab, TAE]
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
n=26 participants at risk
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
n=3 participants at risk
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
n=3 participants at risk
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
|---|---|---|---|
|
Infections and infestations
Abdominal infection
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Hepatobiliary disorders
Biliary tract infection
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
Blood Bilirubin increased
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
General disorders
Fatigue
|
0.00%
0/26 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Cardiac disorders
Heart Failure
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.8%
1/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.5%
3/26 • Number of events 8 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Infections and infestations
Lung infection
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
7.7%
2/26 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Colonic perforation
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
Other adverse events
| Measure |
Group I [Pembrolizumab, 177Lu DOTATATE]
n=26 participants at risk
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
|
Group II [Pembrolizumab, TAE]
n=3 participants at risk
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
|
Group III [Pembrolizumab, Yttrium-90 Microsphere RE]
n=3 participants at risk
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
|
|---|---|---|---|
|
Gastrointestinal disorders
Duodenal ulcer
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Nervous system disorders
Dysesthesia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Eye disorders
Flashing lights
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Eye disorders
Glaucoma
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Vascular disorders
Hot flashes
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Ileus
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Nervous system disorders
Memory impairment
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Reproductive system and breast disorders
Testicular pain
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Endocrine disorders
Testosterone deficiency
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Infections and infestations
Thrush
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Weight Gain
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Bloating
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Eye disorders
Blurred Vision
|
3.8%
1/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Number of events 4 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
Creatinine increased
|
11.5%
3/26 • Number of events 6 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
26.9%
7/26 • Number of events 15 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
4/26 • Number of events 5 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
General disorders
Edema limbs
|
15.4%
4/26 • Number of events 4 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
General disorders
Fatigue
|
65.4%
17/26 • Number of events 27 • Up to 3 years
|
100.0%
3/3 • Number of events 3 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
|
General disorders
Fever
|
15.4%
4/26 • Number of events 5 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
|
General disorders
Flu like symptoms
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Nervous system disorders
Headache
|
15.4%
4/26 • Number of events 4 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Endocrine disorders
Hyperglycemia
|
19.2%
5/26 • Number of events 5 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Endocrine disorders
Hyperthyroidism
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
2/26 • Number of events 3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
2/26 • Number of events 6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
7.7%
2/26 • Number of events 4 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Endocrine disorders
Hypothyroidism
|
19.2%
5/26 • Number of events 6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
19.2%
5/26 • Number of events 7 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
INR increased
|
0.00%
0/26 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/26 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
100.0%
3/3 • Number of events 3 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
7.7%
2/26 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
46.2%
12/26 • Number of events 19 • Up to 3 years
|
100.0%
3/3 • Number of events 3 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
11.5%
3/26 • Number of events 4 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
2/26 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
General disorders
Pain
|
11.5%
3/26 • Number of events 3 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
15.4%
4/26 • Number of events 5 • Up to 3 years
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
34.6%
9/26 • Number of events 12 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
38.5%
10/26 • Number of events 15 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Infections and infestations
Skin infection
|
7.7%
2/26 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
11.5%
3/26 • Number of events 5 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
26.9%
7/26 • Number of events 11 • Up to 3 years
|
33.3%
1/3 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Weight Loss
|
3.8%
1/26 • Number of events 2 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Cheilitis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
General disorders
Chills
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Psychiatric disorders
Confusion
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Infections and infestations
Conjunctivitis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
23.1%
6/26 • Number of events 7 • Up to 3 years
|
66.7%
2/3 • Number of events 6 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Reproductive system and breast disorders
Allergic rhinitis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.4%
4/26 • Number of events 4 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
19.2%
5/26 • Number of events 7 • Up to 3 years
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
11.5%
3/26 • Number of events 5 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
|
Psychiatric disorders
Anxiety
|
11.5%
3/26 • Number of events 3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.8%
8/26 • Number of events 13 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
6/26 • Number of events 9 • Up to 3 years
|
66.7%
2/3 • Number of events 4 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/26 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
15.4%
4/26 • Number of events 4 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
66.7%
2/3 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
42.3%
11/26 • Number of events 16 • Up to 3 years
|
66.7%
2/3 • Number of events 3 • Up to 3 years
|
33.3%
1/3 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Acidosis
|
7.7%
2/26 • Number of events 2 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
General disorders
Non-cardiac chest pain
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Oral pain
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Nervous system disorders
Paresthesia
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Infections and infestations
Shingles
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Infections and infestations
Sinusitis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
3.8%
1/26 • Number of events 1 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
0.00%
0/3 • Up to 3 years
|
Additional Information
Dr. Nicholas Fidelman , MD
University of California, San Francisco
Phone: (415-476-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place