Clinical trialPhase 1 / Phase 2Completed
A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread
Phase 1/2 Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab Combined With Daratumumab in Participants With Advanced or Metastatic Solid Tumors
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 15 June 2017
- Expected end
- 6 July 2020
- Enrollment
- 105 participants
- Sites
- 20
- Primary outcomes
- Number of Participants With Adverse Events (AEs); Number of Participants With Serious Adverse Events (SAEs); Number of Participants With Laboratory Abnormalities in Specific Liver Tests; Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests; Number of Participants With Laboratory Results of Worst CTC Grade
- Sponsor
- Industry
- Results posted
- 2021-07-23
- Last update
- 23 July 2021
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Adverse Events (AEs) [From first dose to 30 days post last dose (up to 34 months)]. Count Of Participants, Participants. Nivolumab + Daratumumab (TNBC) (n=41): 41; Nivolumab + Daratumumab (NSCLC) (n=21): 21; Nivolumab + Daratumumab (PAC) (n=43): 42.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Serious Adverse Events (SAEs) [From first dose to 30 days post last dose (up to 34 months)]. Count Of Participants, Participants. Nivolumab + Daratumumab (TNBC) (n=41): 29; Nivolumab + Daratumumab (NSCLC) (n=21): 14; Nivolumab + Daratumumab (PAC) (n=43): 29.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Laboratory Abnormalities in Specific Liver Tests [From first dose to 30 days post last dose (up to 34 months)]. Count Of Participants, Participants. ALT OR AST > 3XULN: Nivolumab + Daratumumab (TNBC) (n=37): 6; Nivolumab + Daratumumab (NSCLC) (n=21): 2; Nivolumab + Daratumumab (PAC) (n=43): 10. ALT OR AST > 5XULN: Nivolumab + Daratumumab (TNBC) (n=37): 5; Nivolumab + Daratumumab (NSCLC) (n=21): 2; Nivolumab + Daratumumab (PAC) (n=43): 6. ALT OR AST > 10XULN: Nivolumab + Daratumumab (TNBC) (n=37): 2; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 3. ALT OR AST > 20XULN: Nivolumab + Daratumumab (TNBC) (n=37): 0; Nivolumab + Daratumumab (NSCLC) (n=21): 0; Nivolumab + Daratumumab (PAC) (n=43): 0. TOTAL BILIRUBIN > 2XULN: Nivolumab + Daratumumab (TNBC) (n=37): 1; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 8. ALP > 1.5XULN: Nivolumab + Daratumumab (TNBC) (n=37): 10; Nivolumab + Daratumumab (NSCLC) (n=21): 5; Nivolumab + Daratumumab (PAC) (n=43): 34. CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN ONE DAY: Nivolumab + Daratumumab (TNBC) (n=37): 1; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 5. CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN 30 DAYS: Nivolumab + Daratumumab (TNBC) (n=37): 1; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 5. CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY: Nivolumab + Daratumumab (TNBC) (n=37): 1; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 5. CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS: Nivolumab + Daratumumab (TNBC) (n=37): 1; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 5.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests [From first dose to 30 days post last dose (up to 34 months)]. Count Of Participants, Participants. TSH > ULN: Nivolumab + Daratumumab (TNBC) (n=16): 4; Nivolumab + Daratumumab (NSCLC) (n=15): 3; Nivolumab + Daratumumab (PAC) (n=21): 4. TSH > ULN WITH TSH <= ULN AT BASELINE: Nivolumab + Daratumumab (TNBC) (n=16): 4; Nivolumab + Daratumumab (NSCLC) (n=15): 3; Nivolumab + Daratumumab (PAC) (n=21): 2. TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN: Nivolumab + Daratumumab (TNBC) (n=16): 1; Nivolumab + Daratumumab (NSCLC) (n=15): 1; Nivolumab + Daratumumab (PAC) (n=21): 3. TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN: Nivolumab + Daratumumab (TNBC) (n=16): 2; Nivolumab + Daratumumab (NSCLC) (n=15): 2; Nivolumab + Daratumumab (PAC) (n=21): 0. TSH > ULN WITH FT3/FT4 TEST MISSING: Nivolumab + Daratumumab (TNBC) (n=16): 1; Nivolumab + Daratumumab (NSCLC) (n=15): 0; Nivolumab + Daratumumab (PAC) (n=21): 1. TSH < LLN: Nivolumab + Daratumumab (TNBC) (n=16): 1; Nivolumab + Daratumumab (NSCLC) (n=15): 2; Nivolumab + Daratumumab (PAC) (n=21): 2. TSH < LLN WITH TSH >= LLN AT BASELINE: Nivolumab + Daratumumab (TNBC) (n=16): 1; Nivolumab + Daratumumab (NSCLC) (n=15): 2; Nivolumab + Daratumumab (PAC) (n=21): 1. TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN: Nivolumab + Daratumumab (TNBC) (n=16): 1; Nivolumab + Daratumumab (NSCLC) (n=15): 0; Nivolumab + Daratumumab (PAC) (n=21): 0. TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN: Nivolumab + Daratumumab (TNBC) (n=16): 0; Nivolumab + Daratumumab (NSCLC) (n=15): 2; Nivolumab + Daratumumab (PAC) (n=21): 1. TSH < LLN WITH FT3/FT4 TEST MISSING: Nivolumab + Daratumumab (TNBC) (n=16): 0; Nivolumab + Daratumumab (NSCLC) (n=15): 0; Nivolumab + Daratumumab (PAC) (n=21): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) [Up to 36 months]. Number, Percentage of Participants (95% Confidence Interval). Nivolumab + Daratumumab (TNBC) (n=41): 4.9 (0.6 to 16.5); Nivolumab + Daratumumab (NSCLC) (n=21): 9.5 (1.2 to 30.4); Nivolumab + Daratumumab (PAC) (n=43): 0 (0.0 to 8.2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response (DOR) [Up to 36 months]. Median, Months (95% Confidence Interval). Nivolumab + Daratumumab (TNBC) (n=2): 4.17 (NA to NA) [not estimable, could not be calculated due to too few events.]; Nivolumab + Daratumumab (NSCLC) (n=2): 9.40 (7.72 to 11.07).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Best Overall Response (BOR) [Up to 36 months]. Count Of Participants, Participants. Complete Response (CR): Nivolumab + Daratumumab (TNBC) (n=41): 0; Nivolumab + Daratumumab (NSCLC) (n=21): 0; Nivolumab + Daratumumab (PAC) (n=43): 0. Partial Response (PR): Nivolumab + Daratumumab (TNBC) (n=41): 2; Nivolumab + Daratumumab (NSCLC) (n=21): 2; Nivolumab + Daratumumab (PAC) (n=43): 0. Stable Disease (SD): Nivolumab + Daratumumab (TNBC) (n=41): 8; Nivolumab + Daratumumab (NSCLC) (n=21): 10; Nivolumab + Daratumumab (PAC) (n=43): 9. Progressive Disease (PD): Nivolumab + Daratumumab (TNBC) (n=41): 22; Nivolumab + Daratumumab (NSCLC) (n=21): 9; Nivolumab + Daratumumab (PAC) (n=43): 31. Unable to Determine (UTD): Nivolumab + Daratumumab (TNBC) (n=41): 9; Nivolumab + Daratumumab (NSCLC) (n=21): 0; Nivolumab + Daratumumab (PAC) (n=43): 3.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [Up to 36 months]. Median, Months (95% Confidence Interval). Nivolumab + Daratumumab (TNBC) (n=41): 1.22 (1.15 to 1.41); Nivolumab + Daratumumab (NSCLC) (n=21): 4.85 (1.12 to 7.69); Nivolumab + Daratumumab (PAC) (n=43): 1.22 (1.15 to 1.38).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Nivolumab Serum Concentrations [From day 1 to follow-up 2 (up to 36 months)]. Geometric Mean, µg/mL (Geometric Coefficient of Variation). Cycle 3 Day 1: Nivolumab + Daratumumab (TNBC) (n=41): 52.9 (34.8); Nivolumab (NSCLC) (n=21): 43.5 (26.6); Nivolumab (PAC) (n=43): 42.5 (29.7). Cycle 4 Day 1: Nivolumab + Daratumumab (TNBC) (n=41): 87.0 (34.0); Nivolumab (NSCLC) (n=21): 77.9 (37.6); Nivolumab (PAC) (n=43): 64.3 (31.4). Cycle 7 Day 1: Nivolumab + Daratumumab (TNBC) (n=41): 44.8 (32.8); Nivolumab (NSCLC) (n=21): 116.2 (23.8); Nivolumab (PAC) (n=43): 83.3 (NA) [Coefficient of variation could not be calculated for PAC cohort due to small number of participants analyzed.]. Cycle 11 Day 1: Nivolumab (NSCLC) (n=21): 124.3 (46.5). Follow-up 1: Nivolumab + Daratumumab (TNBC) (n=41): 48.9 (44.0); Nivolumab (NSCLC) (n=21): 71.6 (58.9); Nivolumab (PAC) (n=43): 32.8 (48.6). Follow-up 2: Nivolumab + Daratumumab (TNBC) (n=41): 23.5 (60.6); Nivolumab (NSCLC) (n=21): 17.4 (96.1); Nivolumab (PAC) (n=43): 6.3 (89.7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Daratumumab Serum Concentrations [From day 1 to follow-up 2 (up to 36 months)]. Geometric Mean, µg/mL (Geometric Coefficient of Variation). Cycle 1 Day 1 (hour 8): Nivolumab + Daratumumab (TNBC) (n=41): 334.1819 (28.1); Daratumumab (NSCLC) (n=21): 310.7272 (15.6); Daratumumab (PAC) (n=43): 277.6708 (28.4). Cycle 2 Day 1 (hour 0): Nivolumab + Daratumumab (TNBC) (n=41): 332.9353 (29.6); Daratumumab (NSCLC) (n=21): 321.6084 (25.7); Daratumumab (PAC) (n=43): 275.1521 (35.9). Cycle 2 Day 1 (hour 4): Nivolumab + Daratumumab (TNBC) (n=41): 735.2131 (36.9); Daratumumab (NSCLC) (n=21): 641.8146 (26.3); Daratumumab (PAC) (n=43): 569.8158 (27.4). Cycle 3 day 1: Nivolumab + Daratumumab (TNBC) (n=41): 629.9607 (19.8); Daratumumab (NSCLC) (n=21): 477.6488 (25.0); Daratumumab (PAC) (n=43): 473.0335 (23.8). Cycle 4 day 1: Nivolumab + Daratumumab (TNBC) (n=41): 559.8988 (31.0); Daratumumab (NSCLC) (n=21): 393.5442 (48.9); Daratumumab (PAC) (n=43): 406.9487 (28.2). Cycle 7 day 1: Nivolumab + Daratumumab (TNBC) (n=41): 294.8322 (NA) [Coefficient of variation could not be calculated for TNBC cohort due to small number of participants analyzed.]; Daratumumab (NSCLC) (n=21): 515.2495 (21.9); Daratumumab (PAC) (n=43): 229.0854 (NA) [Coefficient of variation could not be calculated for PAC cohort due to small number of participants analyzed.]. Follow-up 1: Nivolumab + Daratumumab (TNBC) (n=41): 177.5615 (65.0); Daratumumab (NSCLC) (n=21): 157.5960 (62.2); Daratumumab (PAC) (n=43): 184.1510 (51.7). Follow-up 2: Nivolumab + Daratumumab (TNBC) (n=41): 134.0478 (NA) [Coefficient of variation could not be calculated for TNBC cohort due to small number of participants analyzed.]; Daratumumab (NSCLC) (n=21): 57.3349 (NA) [Coefficient of variation could not be calculated for NSCLC cohort due to small number of participants analyzed.]; Daratumumab (PAC) (n=43): 8.4517 (158.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Participants Anti Drug Antibody (ADA) by Positivity [Up to 36 months]. Number, Percentage of Participants. Nivolumab Baseline ADA Positive: Nivolumab + Daratumumab (TNBC) (n=41): 0.00; Nivolumab + Daratumumab (NSCLC) (n=21): 6.3; Nivolumab + Daratumumab (PAC) (n=43): 0.00. Daratumumab Baseline ADA Positive: Nivolumab + Daratumumab (TNBC) (n=41): 0.00; Nivolumab + Daratumumab (NSCLC) (n=21): 5.6; Nivolumab + Daratumumab (PAC) (n=43): 0.00. Nivolumab ADA Positive: Nivolumab + Daratumumab (TNBC) (n=41): 0.00; Nivolumab + Daratumumab (NSCLC) (n=21): 0.00; Nivolumab + Daratumumab (PAC) (n=43): 0.00. Nivolumab ADA Negative: Nivolumab + Daratumumab (TNBC) (n=41): 100.0; Nivolumab + Daratumumab (NSCLC) (n=21): 100.0; Nivolumab + Daratumumab (PAC) (n=43): 100.0. Daratumumab ADA Positive: Nivolumab + Daratumumab (TNBC) (n=41): 0.00; Nivolumab + Daratumumab (NSCLC) (n=21): 0.00; Nivolumab + Daratumumab (PAC) (n=43): 0.00. Daratumumab ADA Negative: Nivolumab + Daratumumab (TNBC) (n=41): 100.0; Nivolumab + Daratumumab (NSCLC) (n=21): 100.0; Nivolumab + Daratumumab (PAC) (n=43): 100.0.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Laboratory Results of Worst CTC Grade [From first dose to 30 days post last dose (up to 34 months)]. Count Of Participants, Participants. Hemoglobin / Grade 0: Nivolumab + Daratumumab (TNBC) (n=41): 13; Nivolumab + Daratumumab (NSCLC) (n=21): 5; Nivolumab + Daratumumab (PAC) (n=43): 5. Hemoglobin / Grade 1: Nivolumab + Daratumumab (TNBC) (n=41): 14; Nivolumab + Daratumumab (NSCLC) (n=21): 9; Nivolumab + Daratumumab (PAC) (n=43): 23. Hemoglobin / Grade 2: Nivolumab + Daratumumab (TNBC) (n=41): 7; Nivolumab + Daratumumab (NSCLC) (n=21): 7; Nivolumab + Daratumumab (PAC) (n=43): 12. Hemoglobin / Grade 3: Nivolumab + Daratumumab (TNBC) (n=41): 5; Nivolumab + Daratumumab (NSCLC) (n=21): 0; Nivolumab + Daratumumab (PAC) (n=43): 3. Hemoglobin / Grade 4: Nivolumab + Daratumumab (TNBC) (n=41): NA [Per Anemia criteria in CTC Version 4.0 there is no grade 4 for hemoglobin]; Nivolumab + Daratumumab (NSCLC) (n=21): NA [Per Anemia criteria in CTC Version 4.0 there is no grade 4 for hemoglobin]; Nivolumab + Daratumumab (PAC) (n=43): NA [Per Anemia criteria in CTC Version 4.0 there is no grade 4 for hemoglobin]. Hemoglobin / Not Reported: Nivolumab + Daratumumab (TNBC) (n=41): 2; Nivolumab + Daratumumab (NSCLC) (n=21): 0; Nivolumab + Daratumumab (PAC) (n=43): 0. Platelet Count / Grade 0: Nivolumab + Daratumumab (TNBC) (n=41): 29; Nivolumab + Daratumumab (NSCLC) (n=21): 16; Nivolumab + Daratumumab (PAC) (n=43): 24. Platelet Count / Grade 1: Nivolumab + Daratumumab (TNBC) (n=41): 4; Nivolumab + Daratumumab (NSCLC) (n=21): 4; Nivolumab + Daratumumab (PAC) (n=43): 18. Platelet Count / Grade 2: Nivolumab + Daratumumab (TNBC) (n=41): 0; Nivolumab + Daratumumab (NSCLC) (n=21): 0; Nivolumab + Daratumumab (PAC) (n=43): 0. Platelet Count / Grade 3: Nivolumab + Daratumumab (TNBC) (n=41): 1; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 1. Platelet Count / Grade 4: Nivolumab + Daratumumab (TNBC) (n=41): 5; Nivolumab + Daratumumab (NSCLC) (n=21): 0; Nivolumab + Daratumumab (PAC) (n=43): 0. Platelet Count / Not Reported: Nivolumab + Daratumumab (TNBC) (n=41): 2; Nivolumab + Daratumumab (NSCLC) (n=21): 0; Nivolumab + Daratumumab (PAC) (n=43): 0. Leukocytes / Grade 0: Nivolumab + Daratumumab (TNBC) (n=41): 27; Nivolumab + Daratumumab (NSCLC) (n=21): 18; Nivolumab + Daratumumab (PAC) (n=43): 35. Leukocytes / Grade 1: Nivolumab + Daratumumab (TNBC) (n=41): 7; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 3. Leukocytes / Grade 2: Nivolumab + Daratumumab (TNBC) (n=41): 4; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 5. Leukocytes / Grade 3: Nivolumab + Daratumumab (TNBC) (n=41): 1; Nivolumab + Daratumumab (NSCLC) (n=21): 1; Nivolumab + Daratumumab (PAC) (n=43): 0. Leukocytes / Grade 4: Nivolumab + Daratumumab (TNBC) (n=41): 0; Nivolumab + Daratumumab (NSCLC) (n=21): 0; Nivolumab + Daratumumab (PAC) (n=43): 0. Leukocytes / Not Reported: Nivolumab + Dar