Trial Outcomes & Findings for Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes (NCT NCT04187833)
NCT ID: NCT04187833
Last Updated: 2025-01-14
Results Overview
Best overall response, defined as complete response (CR) and partial response (PR) by RECIST 1.1 criteria. Complete response (CR) is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
up to 24 months after treatment through study completion, an average of 2 years
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Nivolumab + Talazoparib
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Nivolumab + Talazoparib
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes
Baseline characteristics by cohort
| Measure |
Nivolumab + Talazoparib
n=8 Participants
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Age, Customized
30-39 years old
|
1 Participants
n=99 Participants
|
|
Age, Customized
40-49 years old
|
1 Participants
n=99 Participants
|
|
Age, Customized
50-59 years old
|
1 Participants
n=99 Participants
|
|
Age, Customized
60-69 years old
|
3 Participants
n=99 Participants
|
|
Age, Customized
70-79 years old
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 24 months after treatment through study completion, an average of 2 yearsPopulation: One patient out of 8 was enrolled but experienced a decline in health status before starting treatment and therefore did not receive any study treatment.
Best overall response, defined as complete response (CR) and partial response (PR) by RECIST 1.1 criteria. Complete response (CR) is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Outcome measures
| Measure |
Nivolumab + Talazoparib
n=7 Participants
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Best Overall Response as Defined by RECIST 1.1 Criteria
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 24 months after treatment through study completion, an average of 2 yearsPFS, defined as the time from the first dose of study treatment to the date of disease progression by RECIST 1.1 or death due to any cause, whichever occurs first. Progressive disease (PD) is defined as a ≥20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Nivolumab + Talazoparib
n=7 Participants
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Progression Free Survival (PFS)
|
12 Weeks
Interval 6.0 to 24.0
|
SECONDARY outcome
Timeframe: 30 days after start of treatmentNumber of participants with treatment-related adverse events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Outcome measures
| Measure |
Nivolumab + Talazoparib
n=7 Participants
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 24 months after treatment through study completion, an average of 2 yearsImmune-related overall response (irOR), defined as immune-related complete response (irCR) and immune-related partial response (irPR) by irRECIST
Outcome measures
| Measure |
Nivolumab + Talazoparib
n=7 Participants
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Immune-related Overall Response (irOR) Defined by irRECIST
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 24 months after treatment through study completion, an average of 2 yearsirPFS, defined as the time from the first dose of study treatment to the date of disease progression by irRECIST
Outcome measures
| Measure |
Nivolumab + Talazoparib
n=7 Participants
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Immune-related Progression Free Survival (irPFS)
|
12 Weeks
Interval 6.0 to 24.0
|
SECONDARY outcome
Timeframe: up to 24 months after treatmentOverall survival (OS)
Outcome measures
| Measure |
Nivolumab + Talazoparib
n=7 Participants
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Overall Survival (OS)
|
72 Weeks
Interval 21.0 to
1 participant still alive
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, 12 weeksAnti-tumor response by measure of immune-infiltration of tumor infiltrating lymphocytes including flow cytometry on tumor biopsies and peripheral blood mononuclear cells (PBMCs)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and before each cycle (every 4 weeks) of nivolumab for a period of 12 monthsPatient reported outcomes for adverse events, as measured by PRO-CTCAE while on combination therapy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, 12 weeksEvaluation of DNA landscape as described by total somatic mutation burden by DNA sequencing
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, 12 weeksGene expression by RNA sequencing
Outcome measures
Outcome data not reported
Adverse Events
Nivolumab + Talazoparib
Serious events: 1 serious events
Other events: 8 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Nivolumab + Talazoparib
n=8 participants at risk
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
Blood bilirubin Increased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
Other adverse events
| Measure |
Nivolumab + Talazoparib
n=8 participants at risk
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Nivolumab: 480mg intravenously every 4 weeks (28 days)
Talazoparib: 1mg orally daily
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Gastrointestinal disorders
Dyspenea
|
25.0%
2/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Gastrointestinal disorders
vomiting
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Gastrointestinal disorders
Belching
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
6/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
CPK decreased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
BUN decreased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
General disorders
Chills
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
General disorders
Edema Limbs
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
General disorders
Fatigue
|
50.0%
4/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Infections and infestations
Eye infection
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Infections and infestations
Hepatitis viral
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
White Blood Cells decreased
|
50.0%
4/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
2/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
CPK increased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
Weight loss
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Investigations
CD4 lymphocytes decreased
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
2/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
62.5%
5/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Metabolism and nutrition disorders
Hypolbuminemia
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.5%
3/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Immune system disorders
Arthralgias
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
37.5%
3/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
2/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Psychiatric disorders
Confusion
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Renal and urinary disorders
Urinary Frequency
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
2/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Vascular disorders
Flushing
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months
All-cause Mortality: Only one death occurred within the study window due to disease progression and not related to toxicity from the treatment. The remaining deaths occurred after the study period had ended and were unrelated to the study treatment.
|
Additional Information
James Isaacs, MD
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Phone: 1-866-223-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place