Advanced Cancer
Conditions
Keywords
Non-small cell lung cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Pancreatic Cancer (PAC)
Brief summary
The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.
Interventions
Specified dose on specified days
Specified dose on specified days
Sponsors
Study design
Eligibility
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com * Patients with metastatic or advanced solid tumors * Women with histologically or cytologically confirmed triple negative breast carcinoma * Participants with histologically or cytologically confirmed pancreatic adenocarcinoma * Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)
Exclusion criteria
* Active brain metastases or leptomeningeal metastases. * Any serious or uncontrolled medical disorder * Prior malignancy active within the previous 3 years Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From first dose to 30 days post last dose (up to 34 months) | 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 |
| Number of Participants With Serious Adverse Events (SAEs) | From first dose to 30 days post last dose (up to 34 months) | 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 |
| Number of Participants With Laboratory Abnormalities in Specific Liver Tests | From first dose to 30 days post last dose (up to 34 months) | 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 |
| Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | From first dose to 30 days post last dose (up to 34 months) | 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 |
| Number of Participants With Laboratory Results of Worst CTC Grade | From first dose to 30 days post last dose (up to 34 months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daratumumab Serum Concentrations | From day 1 to follow-up 2 (up to 36 months) | Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab |
| Objective Response Rate (ORR) | Up to 36 months | 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) |
| Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Up to 36 months | 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 |
| Duration of Response (DOR) | Up to 36 months | 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 |
| Best Overall Response (BOR) | Up to 36 months | 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. |
| Progression Free Survival (PFS) | Up to 36 months | 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. |
| Nivolumab Serum Concentrations | From day 1 to follow-up 2 (up to 36 months) | Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab |
Countries
Australia, Canada, France, Germany, Italy, Puerto Rico, Spain, Switzerland, United States
Participant flow
Pre-assignment details
105 participants treated
Participants by arm
| Arm | Count |
|---|---|
| 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) | 41 |
| 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) | 21 |
| 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) | 43 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative reason by sponsor | 0 | 0 | 1 |
| Overall Study | Adverse Event unrelated to Study Drug | 6 | 0 | 1 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Disease Progression | 30 | 19 | 41 |
| Overall Study | Other reasons | 2 | 0 | 0 |
| Overall Study | Study Drug Toxicity | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Nivolumab + Daratumumab (TNBC) | Nivolumab + Daratumumab (NSCLC) | Nivolumab + Daratumumab (PAC) | Total |
|---|---|---|---|---|
| Age, Continuous | 55.1 Years STANDARD_DEVIATION 13.1 | 59.5 Years STANDARD_DEVIATION 8.5 | 61.9 Years STANDARD_DEVIATION 9.4 | 58.8 Years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 3 Participants | 21 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 18 Participants | 22 Participants | 60 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 0 Participants | 8 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 33 Participants | 21 Participants | 35 Participants | 89 Participants |
| Sex: Female, Male Female | 41 Participants | 7 Participants | 20 Participants | 68 Participants |
| Sex: Female, Male Male | 0 Participants | 14 Participants | 23 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 29 / 41 | 11 / 21 | 36 / 43 |
| other Total, other adverse events | 40 / 41 | 21 / 21 | 41 / 43 |
| serious Total, serious adverse events | 36 / 41 | 17 / 21 | 36 / 43 |
Outcome results
Number of Participants With Adverse Events (AEs)
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
Time frame: From first dose to 30 days post last dose (up to 34 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Adverse Events (AEs) | 41 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Adverse Events (AEs) | 21 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Adverse Events (AEs) | 42 Participants |
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
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
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3XULN | 6 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 5XULN | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 10XULN | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5XULN | 10 Participants |
| Nivolumab + Daratumumab (TNBC) | 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 |
| Nivolumab + Daratumumab (TNBC) | 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 |
| Nivolumab + Daratumumab (TNBC) | 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 |
| Nivolumab + Daratumumab (TNBC) | 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 |
| Nivolumab + Daratumumab (NSCLC) | 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 |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3XULN | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5XULN | 5 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 5XULN | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | 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 |
| Nivolumab + Daratumumab (NSCLC) | 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 |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 10XULN | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | 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 |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN 30 DAYS | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 8 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5XULN | 34 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN ONE DAY | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3XULN | 10 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 5XULN | 6 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 10XULN | 3 Participants |
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
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
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 3 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 3 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 2 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 4 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 2 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 3 Participants |
Number of Participants With Laboratory Results of Worst CTC Grade
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
Time frame: From first dose to 30 days post last dose (up to 34 months)
Population: All treated participants
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 0 | 13 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 2 | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 0 | 30 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 0 | 33 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 1 | 14 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 2 | 7 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 3 | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 4 | NA Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Not Reported | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 0 | 29 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 4 | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Not Reported | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 0 | 27 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 1 | 7 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 2 | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Not Reported | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 0 | 23 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 1 | 7 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 3 | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Not Reported | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 0 | 16 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 1 | 15 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 2 | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 3 | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Not Reported | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 0 | 19 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 1 | 15 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 3 | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Not Reported | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 0 | 30 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 1 | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Not Reported | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 0 | 30 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 1 | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Not Reported | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 0 | 29 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 1 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 2 | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 3 | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Not Reported | 6 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 0 | 15 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 1 | 13 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 2 | 6 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Not Reported | 7 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 0 | 9 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Not Reported | 31 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 0 | 15 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Not Reported | 25 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 0 | 35 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Not Reported | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 0 | 23 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 1 | 12 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Not Reported | 5 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 2 | 3 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Not Reported | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 0 | 33 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Not Reported | 4 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 0 | 33 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 1 | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Not Reported | 6 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 0 | 25 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 1 | 8 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 2 | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Not Reported | 6 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 0 | 34 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Not Reported | 6 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 1 | 2 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Not Reported | 6 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 0 | 10 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 1 | 9 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Not Reported | 22 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 0 | 19 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 1 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Not Reported | 22 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 0 | 21 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 0 | 14 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 0 | 15 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 1 | 5 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 1 | 7 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 0 | 15 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 1 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 2 | 5 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 0 | 15 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 2 | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 0 | 18 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 1 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Not Reported | 13 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 0 | 6 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Not Reported | 15 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Not Reported | 13 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 0 | 20 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 1 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 0 | 12 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 1 | 7 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 0 | 6 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 0 | 18 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 0 | 17 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 0 | 5 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 1 | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 1 | 3 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 0 | 17 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Not Reported | 15 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 0 | 5 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 1 | 9 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 2 | 7 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 4 | NA Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 0 | 19 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 0 | 16 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 1 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 0 | 13 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 3 | 3 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 0 | 16 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 0 | 16 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 1 | 3 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 0 | 12 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 0 | 1 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 1 | 6 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 3 | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 1 | 13 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 0 | 30 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 2 | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 2 | 3 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 0 | 7 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 3 | 6 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 0 | 35 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 1 | 19 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Bilirubin | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 0 | 15 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 0 | 36 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 0 | 38 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 2 | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 0 | 42 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 1 | 21 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 1 | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 1 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Creatinine | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 2 | 6 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 0 | 33 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 1 | 2 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 3 | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 2 | 4 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 0 | 14 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 3 | 3 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 0 | 6 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 1 | 6 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Phosphorous | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 0 | 15 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Not Reported | 27 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 1 | 11 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 1 | 14 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypocalcemia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 0 | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 2 | 12 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 1 | 23 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 2 | 13 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Albumin | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 0 | 40 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 1 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 2 | 12 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 3 | 3 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 1 | 2 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperkalemia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 3 | 13 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Amylase | Not Reported | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Grade 4 | NA Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 0 | 31 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 1 | 5 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hemoglobin | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 2 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 0 | 24 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 3 | 3 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Grade 4 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 1 | 18 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 0 | 33 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Lipase | Not Reported | 2 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypoglycemia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 1 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 3 | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyperglycemia | Not Reported | 28 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alkaline Phosphatase | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypercalcemia | Grade 0 | 42 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypermagnesemia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 1 | 6 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypernatremia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 0 | 38 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 0 | 19 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 0 | 20 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Platelet Count | Not Reported | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Aspartate Aminotransferase | Grade 0 | 20 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 1 | 15 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 0 | 35 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Not Reported | 1 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 2 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Alanine Aminotransferase | Grade 3 | 4 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 3 | 7 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypomagnesemia | Grade 1 | 4 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Leukocytes | Grade 1 | 3 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hyponatremia | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Laboratory Results of Worst CTC Grade | Hypokalemia | Grade 3 | 3 Participants |
Number of Participants With Serious Adverse Events (SAEs)
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
Time frame: From first dose to 30 days post last dose (up to 34 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Number of Participants With Serious Adverse Events (SAEs) | 29 Participants |
| Nivolumab + Daratumumab (NSCLC) | Number of Participants With Serious Adverse Events (SAEs) | 14 Participants |
| Nivolumab + Daratumumab (PAC) | Number of Participants With Serious Adverse Events (SAEs) | 29 Participants |
Best Overall Response (BOR)
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.
Time frame: Up to 36 months
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Best Overall Response (BOR) | Progressive Disease (PD) | 22 Participants |
| Nivolumab + Daratumumab (TNBC) | Best Overall Response (BOR) | Stable Disease (SD) | 8 Participants |
| Nivolumab + Daratumumab (TNBC) | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Nivolumab + Daratumumab (TNBC) | Best Overall Response (BOR) | Unable to Determine (UTD) | 9 Participants |
| Nivolumab + Daratumumab (TNBC) | Best Overall Response (BOR) | Partial Response (PR) | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | Best Overall Response (BOR) | Partial Response (PR) | 2 Participants |
| Nivolumab + Daratumumab (NSCLC) | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Nivolumab + Daratumumab (NSCLC) | Best Overall Response (BOR) | Stable Disease (SD) | 10 Participants |
| Nivolumab + Daratumumab (NSCLC) | Best Overall Response (BOR) | Progressive Disease (PD) | 9 Participants |
| Nivolumab + Daratumumab (NSCLC) | Best Overall Response (BOR) | Unable to Determine (UTD) | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Best Overall Response (BOR) | Unable to Determine (UTD) | 3 Participants |
| Nivolumab + Daratumumab (PAC) | Best Overall Response (BOR) | Progressive Disease (PD) | 31 Participants |
| Nivolumab + Daratumumab (PAC) | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| Nivolumab + Daratumumab (PAC) | Best Overall Response (BOR) | Stable Disease (SD) | 9 Participants |
| Nivolumab + Daratumumab (PAC) | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
Daratumumab Serum Concentrations
Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab
Time frame: From day 1 to follow-up 2 (up to 36 months)
Population: All pharmacokinetic participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Daratumumab Serum Concentrations | Cycle 7 day 1 | 294.8322 µg/mL | — |
| Nivolumab + Daratumumab (TNBC) | Daratumumab Serum Concentrations | Cycle 2 Day 1 (hour 4) | 735.2131 µg/mL | Geometric Coefficient of Variation 36.9 |
| Nivolumab + Daratumumab (TNBC) | Daratumumab Serum Concentrations | Follow-up 2 | 134.0478 µg/mL | — |
| Nivolumab + Daratumumab (TNBC) | Daratumumab Serum Concentrations | Cycle 4 day 1 | 559.8988 µg/mL | Geometric Coefficient of Variation 31 |
| Nivolumab + Daratumumab (TNBC) | Daratumumab Serum Concentrations | Cycle 3 day 1 | 629.9607 µg/mL | Geometric Coefficient of Variation 19.8 |
| Nivolumab + Daratumumab (TNBC) | Daratumumab Serum Concentrations | Follow-up 1 | 177.5615 µg/mL | Geometric Coefficient of Variation 65 |
| Nivolumab + Daratumumab (TNBC) | Daratumumab Serum Concentrations | Cycle 2 Day 1 (hour 0) | 332.9353 µg/mL | Geometric Coefficient of Variation 29.6 |
| Nivolumab + Daratumumab (TNBC) | Daratumumab Serum Concentrations | Cycle 1 Day 1 (hour 8) | 334.1819 µg/mL | Geometric Coefficient of Variation 28.1 |
| Nivolumab + Daratumumab (NSCLC) | Daratumumab Serum Concentrations | Cycle 3 day 1 | 477.6488 µg/mL | Geometric Coefficient of Variation 25 |
| Nivolumab + Daratumumab (NSCLC) | Daratumumab Serum Concentrations | Follow-up 2 | 57.3349 µg/mL | — |
| Nivolumab + Daratumumab (NSCLC) | Daratumumab Serum Concentrations | Cycle 1 Day 1 (hour 8) | 310.7272 µg/mL | Geometric Coefficient of Variation 15.6 |
| Nivolumab + Daratumumab (NSCLC) | Daratumumab Serum Concentrations | Cycle 2 Day 1 (hour 0) | 321.6084 µg/mL | Geometric Coefficient of Variation 25.7 |
| Nivolumab + Daratumumab (NSCLC) | Daratumumab Serum Concentrations | Cycle 2 Day 1 (hour 4) | 641.8146 µg/mL | Geometric Coefficient of Variation 26.3 |
| Nivolumab + Daratumumab (NSCLC) | Daratumumab Serum Concentrations | Cycle 4 day 1 | 393.5442 µg/mL | Geometric Coefficient of Variation 48.9 |
| Nivolumab + Daratumumab (NSCLC) | Daratumumab Serum Concentrations | Cycle 7 day 1 | 515.2495 µg/mL | Geometric Coefficient of Variation 21.9 |
| Nivolumab + Daratumumab (NSCLC) | Daratumumab Serum Concentrations | Follow-up 1 | 157.5960 µg/mL | Geometric Coefficient of Variation 62.2 |
| Nivolumab + Daratumumab (PAC) | Daratumumab Serum Concentrations | Cycle 4 day 1 | 406.9487 µg/mL | Geometric Coefficient of Variation 28.2 |
| Nivolumab + Daratumumab (PAC) | Daratumumab Serum Concentrations | Cycle 2 Day 1 (hour 0) | 275.1521 µg/mL | Geometric Coefficient of Variation 35.9 |
| Nivolumab + Daratumumab (PAC) | Daratumumab Serum Concentrations | Follow-up 1 | 184.1510 µg/mL | Geometric Coefficient of Variation 51.7 |
| Nivolumab + Daratumumab (PAC) | Daratumumab Serum Concentrations | Cycle 7 day 1 | 229.0854 µg/mL | — |
| Nivolumab + Daratumumab (PAC) | Daratumumab Serum Concentrations | Cycle 1 Day 1 (hour 8) | 277.6708 µg/mL | Geometric Coefficient of Variation 28.4 |
| Nivolumab + Daratumumab (PAC) | Daratumumab Serum Concentrations | Cycle 3 day 1 | 473.0335 µg/mL | Geometric Coefficient of Variation 23.8 |
| Nivolumab + Daratumumab (PAC) | Daratumumab Serum Concentrations | Cycle 2 Day 1 (hour 4) | 569.8158 µg/mL | Geometric Coefficient of Variation 27.4 |
| Nivolumab + Daratumumab (PAC) | Daratumumab Serum Concentrations | Follow-up 2 | 8.4517 µg/mL | Geometric Coefficient of Variation 158.4 |
Duration of Response (DOR)
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
Time frame: Up to 36 months
Population: All treated participants with objective response
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Duration of Response (DOR) | 4.17 Months |
| Nivolumab + Daratumumab (NSCLC) | Duration of Response (DOR) | 9.40 Months |
Nivolumab Serum Concentrations
Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab
Time frame: From day 1 to follow-up 2 (up to 36 months)
Population: All pharmacokinetic participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Nivolumab Serum Concentrations | Cycle 7 Day 1 | 44.8 µg/mL | Geometric Coefficient of Variation 32.8 |
| Nivolumab + Daratumumab (TNBC) | Nivolumab Serum Concentrations | Cycle 3 Day 1 | 52.9 µg/mL | Geometric Coefficient of Variation 34.8 |
| Nivolumab + Daratumumab (TNBC) | Nivolumab Serum Concentrations | Cycle 4 Day 1 | 87.0 µg/mL | Geometric Coefficient of Variation 34 |
| Nivolumab + Daratumumab (TNBC) | Nivolumab Serum Concentrations | Follow-up 2 | 23.5 µg/mL | Geometric Coefficient of Variation 60.6 |
| Nivolumab + Daratumumab (TNBC) | Nivolumab Serum Concentrations | Follow-up 1 | 48.9 µg/mL | Geometric Coefficient of Variation 44 |
| Nivolumab + Daratumumab (NSCLC) | Nivolumab Serum Concentrations | Cycle 11 Day 1 | 124.3 µg/mL | Geometric Coefficient of Variation 46.5 |
| Nivolumab + Daratumumab (NSCLC) | Nivolumab Serum Concentrations | Cycle 4 Day 1 | 77.9 µg/mL | Geometric Coefficient of Variation 37.6 |
| Nivolumab + Daratumumab (NSCLC) | Nivolumab Serum Concentrations | Follow-up 2 | 17.4 µg/mL | Geometric Coefficient of Variation 96.1 |
| Nivolumab + Daratumumab (NSCLC) | Nivolumab Serum Concentrations | Follow-up 1 | 71.6 µg/mL | Geometric Coefficient of Variation 58.9 |
| Nivolumab + Daratumumab (NSCLC) | Nivolumab Serum Concentrations | Cycle 7 Day 1 | 116.2 µg/mL | Geometric Coefficient of Variation 23.8 |
| Nivolumab + Daratumumab (NSCLC) | Nivolumab Serum Concentrations | Cycle 3 Day 1 | 43.5 µg/mL | Geometric Coefficient of Variation 26.6 |
| Nivolumab + Daratumumab (PAC) | Nivolumab Serum Concentrations | Follow-up 2 | 6.3 µg/mL | Geometric Coefficient of Variation 89.7 |
| Nivolumab + Daratumumab (PAC) | Nivolumab Serum Concentrations | Cycle 3 Day 1 | 42.5 µg/mL | Geometric Coefficient of Variation 29.7 |
| Nivolumab + Daratumumab (PAC) | Nivolumab Serum Concentrations | Cycle 7 Day 1 | 83.3 µg/mL | — |
| Nivolumab + Daratumumab (PAC) | Nivolumab Serum Concentrations | Follow-up 1 | 32.8 µg/mL | Geometric Coefficient of Variation 48.6 |
| Nivolumab + Daratumumab (PAC) | Nivolumab Serum Concentrations | Cycle 4 Day 1 | 64.3 µg/mL | Geometric Coefficient of Variation 31.4 |
Objective Response Rate (ORR)
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)
Time frame: Up to 36 months
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Objective Response Rate (ORR) | 4.9 Percentage of Participants |
| Nivolumab + Daratumumab (NSCLC) | Objective Response Rate (ORR) | 9.5 Percentage of Participants |
| Nivolumab + Daratumumab (PAC) | Objective Response Rate (ORR) | 0 Percentage of Participants |
Percentage of Participants Anti Drug Antibody (ADA) by Positivity
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
Time frame: Up to 36 months
Population: All immunogenicity participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Nivolumab Baseline ADA Positive | 0.00 Percentage of Participants |
| Nivolumab + Daratumumab (TNBC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Daratumumab Baseline ADA Positive | 0.00 Percentage of Participants |
| Nivolumab + Daratumumab (TNBC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Nivolumab ADA Positive | 0.00 Percentage of Participants |
| Nivolumab + Daratumumab (TNBC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Nivolumab ADA Negative | 100.0 Percentage of Participants |
| Nivolumab + Daratumumab (TNBC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Daratumumab ADA Positive | 0.00 Percentage of Participants |
| Nivolumab + Daratumumab (TNBC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Daratumumab ADA Negative | 100.0 Percentage of Participants |
| Nivolumab + Daratumumab (NSCLC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Daratumumab ADA Negative | 100.0 Percentage of Participants |
| Nivolumab + Daratumumab (NSCLC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Nivolumab Baseline ADA Positive | 6.3 Percentage of Participants |
| Nivolumab + Daratumumab (NSCLC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Nivolumab ADA Negative | 100.0 Percentage of Participants |
| Nivolumab + Daratumumab (NSCLC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Daratumumab ADA Positive | 0.00 Percentage of Participants |
| Nivolumab + Daratumumab (NSCLC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Daratumumab Baseline ADA Positive | 5.6 Percentage of Participants |
| Nivolumab + Daratumumab (NSCLC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Nivolumab ADA Positive | 0.00 Percentage of Participants |
| Nivolumab + Daratumumab (PAC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Daratumumab Baseline ADA Positive | 0.00 Percentage of Participants |
| Nivolumab + Daratumumab (PAC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Nivolumab ADA Positive | 0.00 Percentage of Participants |
| Nivolumab + Daratumumab (PAC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Daratumumab ADA Negative | 100.0 Percentage of Participants |
| Nivolumab + Daratumumab (PAC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Nivolumab ADA Negative | 100.0 Percentage of Participants |
| Nivolumab + Daratumumab (PAC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Nivolumab Baseline ADA Positive | 0.00 Percentage of Participants |
| Nivolumab + Daratumumab (PAC) | Percentage of Participants Anti Drug Antibody (ADA) by Positivity | Daratumumab ADA Positive | 0.00 Percentage of Participants |
Progression Free Survival (PFS)
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.
Time frame: Up to 36 months
Population: All treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab + Daratumumab (TNBC) | Progression Free Survival (PFS) | 1.22 Months |
| Nivolumab + Daratumumab (NSCLC) | Progression Free Survival (PFS) | 4.85 Months |
| Nivolumab + Daratumumab (PAC) | Progression Free Survival (PFS) | 1.22 Months |