Trial Outcomes & Findings for A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread (NCT NCT03098550)
NCT ID: NCT03098550
Last Updated: 2021-07-23
Results Overview
Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
105 participants
Primary outcome timeframe
From first dose to 30 days post last dose (up to 34 months)
Results posted on
2021-07-23
Participant Flow
105 participants treated
Participant milestones
| Measure |
Nivolumab + Daratumumab (TNBC)
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
21
|
43
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
20
|
43
|
Reasons for withdrawal
| Measure |
Nivolumab + Daratumumab (TNBC)
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Overall Study
Disease Progression
|
30
|
19
|
41
|
|
Overall Study
Study Drug Toxicity
|
2
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Adverse Event unrelated to Study Drug
|
6
|
0
|
1
|
|
Overall Study
Administrative reason by sponsor
|
0
|
0
|
1
|
|
Overall Study
Other reasons
|
2
|
0
|
0
|
Baseline Characteristics
A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread
Baseline characteristics by cohort
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.1 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
61.9 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
58.8 Years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (up to 34 months)Population: All treated participants
Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
41 Participants
|
21 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (up to 34 months)Population: All treated participants
Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
29 Participants
|
14 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (up to 34 months)Population: All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter
Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * ALP \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=37 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 3XULN
|
6 Participants
|
2 Participants
|
10 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 5XULN
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 10XULN
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 20XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
TOTAL BILIRUBIN > 2XULN
|
1 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALP > 1.5XULN
|
10 Participants
|
5 Participants
|
34 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN ONE DAY
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN 30 DAYS
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS
|
1 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (up to 34 months)Population: All treated participants with at least one on-treatment TSH measurement
Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized: * TSH value \> ULN and * with baseline TSH value \<= ULN * with at least one FT3/FT4 test value \< LLN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \>= LLN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test. * TSH \< LLN and * with baseline TSH value \>= LLN * with at least one FT3/FT4 test value \> ULN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \<= ULN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=16 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=15 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=21 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH TSH <= ULN AT BASELINE
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH FT3/FT4 TEST MISSING
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN WITH TSH >= LLN AT BASELINE
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN WITH FT3/FT4 TEST MISSING
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (up to 34 months)Population: All treated participants
Number of participants with laboratory test results of worst (CTC v4.0) grades 0-4 to determine the safety and tolerability of Nivolumab and Daratumumab
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypercalcemia · Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypercalcemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypercalcemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypercalcemia · Not Reported
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hemoglobin · Grade 0
|
13 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hemoglobin · Grade 1
|
14 Participants
|
9 Participants
|
23 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hemoglobin · Grade 2
|
7 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hemoglobin · Grade 3
|
5 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hemoglobin · Grade 4
|
NA Participants
Per Anemia criteria in CTC Version 4.0 there is no grade 4 for hemoglobin
|
NA Participants
Per Anemia criteria in CTC Version 4.0 there is no grade 4 for hemoglobin
|
NA Participants
Per Anemia criteria in CTC Version 4.0 there is no grade 4 for hemoglobin
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hemoglobin · Not Reported
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Platelet Count · Grade 0
|
29 Participants
|
16 Participants
|
24 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Platelet Count · Grade 1
|
4 Participants
|
4 Participants
|
18 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Platelet Count · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Platelet Count · Grade 3
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Platelet Count · Grade 4
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Platelet Count · Not Reported
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Leukocytes · Grade 0
|
27 Participants
|
18 Participants
|
35 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Leukocytes · Grade 1
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Leukocytes · Grade 2
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Leukocytes · Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Leukocytes · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Leukocytes · Not Reported
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alkaline Phosphatase · Grade 0
|
23 Participants
|
13 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alkaline Phosphatase · Grade 1
|
7 Participants
|
4 Participants
|
11 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alkaline Phosphatase · Grade 2
|
4 Participants
|
1 Participants
|
13 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alkaline Phosphatase · Grade 3
|
2 Participants
|
3 Participants
|
13 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alkaline Phosphatase · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alkaline Phosphatase · Not Reported
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Aspartate Aminotransferase · Grade 0
|
16 Participants
|
16 Participants
|
20 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Aspartate Aminotransferase · Grade 1
|
15 Participants
|
3 Participants
|
13 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Aspartate Aminotransferase · Grade 2
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Aspartate Aminotransferase · Grade 3
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Aspartate Aminotransferase · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Aspartate Aminotransferase · Not Reported
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alanine Aminotransferase · Grade 0
|
19 Participants
|
12 Participants
|
19 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alanine Aminotransferase · Grade 1
|
15 Participants
|
6 Participants
|
19 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alanine Aminotransferase · Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alanine Aminotransferase · Grade 3
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alanine Aminotransferase · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Alanine Aminotransferase · Not Reported
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Bilirubin · Grade 0
|
30 Participants
|
18 Participants
|
30 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Bilirubin · Grade 1
|
5 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Bilirubin · Grade 2
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Bilirubin · Grade 3
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Bilirubin · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Bilirubin · Not Reported
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Creatinine · Grade 0
|
30 Participants
|
15 Participants
|
38 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Creatinine · Grade 1
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Creatinine · Grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Creatinine · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Creatinine · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Creatinine · Not Reported
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Phosphorous · Grade 0
|
29 Participants
|
15 Participants
|
33 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Phosphorous · Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Phosphorous · Grade 2
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Phosphorous · Grade 3
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Phosphorous · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Phosphorous · Not Reported
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Albumin · Grade 0
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Albumin · Grade 1
|
13 Participants
|
4 Participants
|
14 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Albumin · Grade 2
|
6 Participants
|
2 Participants
|
12 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Albumin · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Albumin · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Albumin · Not Reported
|
7 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Amylase · Grade 0
|
9 Participants
|
5 Participants
|
36 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Amylase · Grade 1
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Amylase · Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Amylase · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Amylase · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Amylase · Not Reported
|
31 Participants
|
13 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Lipase · Grade 0
|
15 Participants
|
6 Participants
|
31 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Lipase · Grade 1
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Lipase · Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Lipase · Grade 3
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Lipase · Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Lipase · Not Reported
|
25 Participants
|
13 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypernatremia · Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypernatremia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypernatremia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypernatremia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypernatremia · Not Reported
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyponatremia · Grade 0
|
23 Participants
|
12 Participants
|
20 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyponatremia · Grade 1
|
12 Participants
|
7 Participants
|
15 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyponatremia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyponatremia · Grade 3
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyponatremia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyponatremia · Not Reported
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperkalemia · Grade 0
|
30 Participants
|
17 Participants
|
35 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperkalemia · Grade 1
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperkalemia · Grade 2
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperkalemia · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperkalemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperkalemia · Not Reported
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypokalemia · Grade 0
|
33 Participants
|
19 Participants
|
33 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypokalemia · Grade 1
|
4 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypokalemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypokalemia · Grade 3
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypokalemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypokalemia · Not Reported
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypercalcemia · Grade 0
|
33 Participants
|
16 Participants
|
42 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypercalcemia · Grade 1
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypocalcemia · Grade 0
|
25 Participants
|
14 Participants
|
15 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypocalcemia · Grade 1
|
8 Participants
|
7 Participants
|
21 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypocalcemia · Grade 2
|
2 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypocalcemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypocalcemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypocalcemia · Not Reported
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypermagnesemia · Grade 0
|
34 Participants
|
21 Participants
|
40 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypermagnesemia · Grade 1
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypermagnesemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypermagnesemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypermagnesemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypermagnesemia · Not Reported
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypomagnesemia · Grade 0
|
33 Participants
|
17 Participants
|
38 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypomagnesemia · Grade 1
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypomagnesemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypomagnesemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypomagnesemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypomagnesemia · Not Reported
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperglycemia · Grade 0
|
10 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperglycemia · Grade 1
|
9 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperglycemia · Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperglycemia · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperglycemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hyperglycemia · Not Reported
|
22 Participants
|
15 Participants
|
28 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypoglycemia · Grade 0
|
19 Participants
|
6 Participants
|
14 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypoglycemia · Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypoglycemia · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypoglycemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypoglycemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypoglycemia · Not Reported
|
22 Participants
|
15 Participants
|
27 Participants
|
|
Number of Participants With Laboratory Results of Worst CTC Grade
Hypernatremia · Grade 0
|
35 Participants
|
20 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All treated participants
Objective response rate (ORR) is defined as the percentage of treated participants who achieve a best response of complete response (CR) or partial response (PR) based on investigator assessments (using RECIST v1.1 criteria)
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
4.9 Percentage of Participants
Interval 0.6 to 16.5
|
9.5 Percentage of Participants
Interval 1.2 to 30.4
|
0 Percentage of Participants
Interval 0.0 to 8.2
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All treated participants with objective response
Duration of response (DOR) is defined as the time between the date of first documented response (Complete response or partial response) to the date of the first documented tumor progression as determined by Investigator (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=2 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=2 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Duration of Response (DOR)
|
4.17 Months
not estimable, could not be calculated due to too few events.
|
9.40 Months
Interval 7.72 to 11.07
|
—
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All treated participants
Best overall response (BOR) is defined as the best response, as determined by Investigator, recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1 criteria or the date of subsequent therapy, whichever occurs first.
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Best Overall Response (BOR)
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Partial Response (PR)
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Stable Disease (SD)
|
8 Participants
|
10 Participants
|
9 Participants
|
|
Best Overall Response (BOR)
Progressive Disease (PD)
|
22 Participants
|
9 Participants
|
31 Participants
|
|
Best Overall Response (BOR)
Unable to Determine (UTD)
|
9 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All treated participants
Progression Free Survival (PFS) is defined as the time between the date of treatment start day and the date of first documented tumor progression, based on Investigator assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
1.22 Months
Interval 1.15 to 1.41
|
4.85 Months
Interval 1.12 to 7.69
|
1.22 Months
Interval 1.15 to 1.38
|
SECONDARY outcome
Timeframe: From day 1 to follow-up 2 (up to 36 months)Population: All pharmacokinetic participants
Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Nivolumab Serum Concentrations
Cycle 3 Day 1
|
52.9 µg/mL
Geometric Coefficient of Variation 34.8
|
43.5 µg/mL
Geometric Coefficient of Variation 26.6
|
42.5 µg/mL
Geometric Coefficient of Variation 29.7
|
|
Nivolumab Serum Concentrations
Cycle 4 Day 1
|
87.0 µg/mL
Geometric Coefficient of Variation 34.0
|
77.9 µg/mL
Geometric Coefficient of Variation 37.6
|
64.3 µg/mL
Geometric Coefficient of Variation 31.4
|
|
Nivolumab Serum Concentrations
Cycle 7 Day 1
|
44.8 µg/mL
Geometric Coefficient of Variation 32.8
|
116.2 µg/mL
Geometric Coefficient of Variation 23.8
|
83.3 µg/mL
Geometric Coefficient of Variation NA
Coefficient of variation could not be calculated for PAC cohort due to small number of participants analyzed.
|
|
Nivolumab Serum Concentrations
Cycle 11 Day 1
|
—
|
124.3 µg/mL
Geometric Coefficient of Variation 46.5
|
—
|
|
Nivolumab Serum Concentrations
Follow-up 1
|
48.9 µg/mL
Geometric Coefficient of Variation 44.0
|
71.6 µg/mL
Geometric Coefficient of Variation 58.9
|
32.8 µg/mL
Geometric Coefficient of Variation 48.6
|
|
Nivolumab Serum Concentrations
Follow-up 2
|
23.5 µg/mL
Geometric Coefficient of Variation 60.6
|
17.4 µg/mL
Geometric Coefficient of Variation 96.1
|
6.3 µg/mL
Geometric Coefficient of Variation 89.7
|
SECONDARY outcome
Timeframe: From day 1 to follow-up 2 (up to 36 months)Population: All pharmacokinetic participants
Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Daratumumab Serum Concentrations
Cycle 1 Day 1 (hour 8)
|
334.1819 µg/mL
Geometric Coefficient of Variation 28.1
|
310.7272 µg/mL
Geometric Coefficient of Variation 15.6
|
277.6708 µg/mL
Geometric Coefficient of Variation 28.4
|
|
Daratumumab Serum Concentrations
Cycle 2 Day 1 (hour 0)
|
332.9353 µg/mL
Geometric Coefficient of Variation 29.6
|
321.6084 µg/mL
Geometric Coefficient of Variation 25.7
|
275.1521 µg/mL
Geometric Coefficient of Variation 35.9
|
|
Daratumumab Serum Concentrations
Cycle 2 Day 1 (hour 4)
|
735.2131 µg/mL
Geometric Coefficient of Variation 36.9
|
641.8146 µg/mL
Geometric Coefficient of Variation 26.3
|
569.8158 µg/mL
Geometric Coefficient of Variation 27.4
|
|
Daratumumab Serum Concentrations
Cycle 3 day 1
|
629.9607 µg/mL
Geometric Coefficient of Variation 19.8
|
477.6488 µg/mL
Geometric Coefficient of Variation 25.0
|
473.0335 µg/mL
Geometric Coefficient of Variation 23.8
|
|
Daratumumab Serum Concentrations
Cycle 4 day 1
|
559.8988 µg/mL
Geometric Coefficient of Variation 31.0
|
393.5442 µg/mL
Geometric Coefficient of Variation 48.9
|
406.9487 µg/mL
Geometric Coefficient of Variation 28.2
|
|
Daratumumab Serum Concentrations
Cycle 7 day 1
|
294.8322 µg/mL
Geometric Coefficient of Variation NA
Coefficient of variation could not be calculated for TNBC cohort due to small number of participants analyzed.
|
515.2495 µg/mL
Geometric Coefficient of Variation 21.9
|
229.0854 µg/mL
Geometric Coefficient of Variation NA
Coefficient of variation could not be calculated for PAC cohort due to small number of participants analyzed.
|
|
Daratumumab Serum Concentrations
Follow-up 1
|
177.5615 µg/mL
Geometric Coefficient of Variation 65.0
|
157.5960 µg/mL
Geometric Coefficient of Variation 62.2
|
184.1510 µg/mL
Geometric Coefficient of Variation 51.7
|
|
Daratumumab Serum Concentrations
Follow-up 2
|
134.0478 µg/mL
Geometric Coefficient of Variation NA
Coefficient of variation could not be calculated for TNBC cohort due to small number of participants analyzed.
|
57.3349 µg/mL
Geometric Coefficient of Variation NA
Coefficient of variation could not be calculated for NSCLC cohort due to small number of participants analyzed.
|
8.4517 µg/mL
Geometric Coefficient of Variation 158.4
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All immunogenicity participants
Percentage of participants Anti Drug Antibody (ADA) to assess immunogenicity by ADA positive status and ADA negative status, relative to baseline. ADA positive is a participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment. ADA Negative is a participant with no ADA-positive sample after initiation of treatment
Outcome measures
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 Participants
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 Participants
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 Participants
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Percentage of Participants Anti Drug Antibody (ADA) by Positivity
Nivolumab Baseline ADA Positive
|
0.00 Percentage of Participants
|
6.3 Percentage of Participants
|
0.00 Percentage of Participants
|
|
Percentage of Participants Anti Drug Antibody (ADA) by Positivity
Daratumumab Baseline ADA Positive
|
0.00 Percentage of Participants
|
5.6 Percentage of Participants
|
0.00 Percentage of Participants
|
|
Percentage of Participants Anti Drug Antibody (ADA) by Positivity
Nivolumab ADA Positive
|
0.00 Percentage of Participants
|
0.00 Percentage of Participants
|
0.00 Percentage of Participants
|
|
Percentage of Participants Anti Drug Antibody (ADA) by Positivity
Nivolumab ADA Negative
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Anti Drug Antibody (ADA) by Positivity
Daratumumab ADA Positive
|
0.00 Percentage of Participants
|
0.00 Percentage of Participants
|
0.00 Percentage of Participants
|
|
Percentage of Participants Anti Drug Antibody (ADA) by Positivity
Daratumumab ADA Negative
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
Adverse Events
Nivolumab + Daratumumab (TNBC)
Serious events: 36 serious events
Other events: 40 other events
Deaths: 29 deaths
Nivolumab + Daratumumab (NSCLC)
Serious events: 17 serious events
Other events: 21 other events
Deaths: 11 deaths
Nivolumab + Daratumumab (PAC)
Serious events: 36 serious events
Other events: 41 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 participants at risk
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 participants at risk
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 participants at risk
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Cardiac disorders
Cardiac tamponade
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Ileus paralytic
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Asthenia
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Death
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Fatigue
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Generalised oedema
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Pain
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Pyrexia
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
9.3%
4/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Hepatobiliary disorders
Hepatic failure
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Device related infection
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Lung abscess
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Nosocomial infection
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Septic shock
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
General physical condition abnormal
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Liver function test abnormal
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Procalcitonin increased
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Transaminases increased
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
53.7%
22/41 • From first dose to 100 days post last dose (up to 36 months)
|
38.1%
8/21 • From first dose to 100 days post last dose (up to 36 months)
|
58.1%
25/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spinal cord
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Seizure
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
19.5%
8/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Vascular disorders
Embolism
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
Other adverse events
| Measure |
Nivolumab + Daratumumab (TNBC)
n=41 participants at risk
Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (NSCLC)
n=21 participants at risk
Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
Nivolumab + Daratumumab (PAC)
n=43 participants at risk
Pancreatic adenocarcinoma cancer (PAC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.5%
8/41 • From first dose to 100 days post last dose (up to 36 months)
|
28.6%
6/21 • From first dose to 100 days post last dose (up to 36 months)
|
16.3%
7/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Endocrine disorders
Hypothyroidism
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Eye disorders
Vision blurred
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
19.5%
8/41 • From first dose to 100 days post last dose (up to 36 months)
|
19.0%
4/21 • From first dose to 100 days post last dose (up to 36 months)
|
44.2%
19/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.2%
5/41 • From first dose to 100 days post last dose (up to 36 months)
|
19.0%
4/21 • From first dose to 100 days post last dose (up to 36 months)
|
18.6%
8/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
16.3%
7/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Constipation
|
29.3%
12/41 • From first dose to 100 days post last dose (up to 36 months)
|
42.9%
9/21 • From first dose to 100 days post last dose (up to 36 months)
|
30.2%
13/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
22.0%
9/41 • From first dose to 100 days post last dose (up to 36 months)
|
42.9%
9/21 • From first dose to 100 days post last dose (up to 36 months)
|
39.5%
17/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
23.8%
5/21 • From first dose to 100 days post last dose (up to 36 months)
|
14.0%
6/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Nausea
|
39.0%
16/41 • From first dose to 100 days post last dose (up to 36 months)
|
38.1%
8/21 • From first dose to 100 days post last dose (up to 36 months)
|
41.9%
18/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Stomatitis
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Vomiting
|
29.3%
12/41 • From first dose to 100 days post last dose (up to 36 months)
|
28.6%
6/21 • From first dose to 100 days post last dose (up to 36 months)
|
34.9%
15/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Asthenia
|
29.3%
12/41 • From first dose to 100 days post last dose (up to 36 months)
|
57.1%
12/21 • From first dose to 100 days post last dose (up to 36 months)
|
25.6%
11/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Chest pain
|
22.0%
9/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Chills
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
9.3%
4/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Fatigue
|
19.5%
8/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
34.9%
15/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Oedema peripheral
|
12.2%
5/41 • From first dose to 100 days post last dose (up to 36 months)
|
33.3%
7/21 • From first dose to 100 days post last dose (up to 36 months)
|
23.3%
10/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Pain
|
9.8%
4/41 • From first dose to 100 days post last dose (up to 36 months)
|
23.8%
5/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Pyrexia
|
24.4%
10/41 • From first dose to 100 days post last dose (up to 36 months)
|
33.3%
7/21 • From first dose to 100 days post last dose (up to 36 months)
|
32.6%
14/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Immune system disorders
Hypersensitivity
|
14.6%
6/41 • From first dose to 100 days post last dose (up to 36 months)
|
23.8%
5/21 • From first dose to 100 days post last dose (up to 36 months)
|
16.3%
7/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
4/41 • From first dose to 100 days post last dose (up to 36 months)
|
28.6%
6/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
43.9%
18/41 • From first dose to 100 days post last dose (up to 36 months)
|
52.4%
11/21 • From first dose to 100 days post last dose (up to 36 months)
|
41.9%
18/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Alanine aminotransferase increased
|
12.2%
5/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Aspartate aminotransferase increased
|
14.6%
6/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
9.3%
4/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
14.0%
6/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Blood bilirubin increased
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
9.3%
4/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
9.3%
4/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Lymphocyte count decreased
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Weight decreased
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
14.0%
6/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.6%
15/41 • From first dose to 100 days post last dose (up to 36 months)
|
23.8%
5/21 • From first dose to 100 days post last dose (up to 36 months)
|
32.6%
14/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
9.3%
4/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
11.6%
5/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.6%
6/41 • From first dose to 100 days post last dose (up to 36 months)
|
19.0%
4/21 • From first dose to 100 days post last dose (up to 36 months)
|
11.6%
5/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.5%
8/41 • From first dose to 100 days post last dose (up to 36 months)
|
38.1%
8/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.8%
4/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.2%
5/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Headache
|
24.4%
10/41 • From first dose to 100 days post last dose (up to 36 months)
|
19.0%
4/21 • From first dose to 100 days post last dose (up to 36 months)
|
18.6%
8/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Somnolence
|
12.2%
5/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Psychiatric disorders
Anxiety
|
19.5%
8/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
9.3%
4/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Psychiatric disorders
Sleep disorder
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
23.8%
5/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
43.9%
18/41 • From first dose to 100 days post last dose (up to 36 months)
|
23.8%
5/21 • From first dose to 100 days post last dose (up to 36 months)
|
9.3%
4/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.6%
15/41 • From first dose to 100 days post last dose (up to 36 months)
|
28.6%
6/21 • From first dose to 100 days post last dose (up to 36 months)
|
23.3%
10/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.8%
4/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
11.6%
5/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
4/41 • From first dose to 100 days post last dose (up to 36 months)
|
38.1%
8/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Vascular disorders
Flushing
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.2%
5/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Mucosal inflammation
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
General disorders
Non-cardiac chest pain
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Respiratory tract infection
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
19.0%
4/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Blood albumin decreased
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Platelet count decreased
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
Transaminases increased
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Investigations
White blood cell count decreased
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Paraesthesia
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
2.3%
1/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Psychiatric disorders
Depression
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
4.8%
1/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
4.7%
2/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
7.0%
3/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
4.9%
2/41 • From first dose to 100 days post last dose (up to 36 months)
|
14.3%
3/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/41 • From first dose to 100 days post last dose (up to 36 months)
|
9.5%
2/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
|
Vascular disorders
Lymphoedema
|
7.3%
3/41 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/21 • From first dose to 100 days post last dose (up to 36 months)
|
0.00%
0/43 • From first dose to 100 days post last dose (up to 36 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER