Phase 2
Completed N=105
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
Source: ClinicalTrials.gov NCT03098550 ↗Enrolled (actual)
105
Serious AEs
84.8%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 41; 21; 42 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
41; 21; 42 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
29; 14; 29 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in Specific Liver Tests |
6; 2; 10; 5; 2; 6 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests |
4; 3; 4; 4; 3; 2 | — |
| PRIMARY Number of Participants With Laboratory Results of Worst CTC Grade |
13; 5; 5; 14; 9; 23 | — |
| SECONDARY Objective Response Rate (ORR) |
4.9; 9.5; 0 | — |
| SECONDARY Duration of Response (DOR) |
4.17; 9.40 | — |
| SECONDARY Best Overall Response (BOR) |
0; 0; 0; 2; 2; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
1.22; 4.85; 1.22 | — |
| SECONDARY Nivolumab Serum Concentrations |
52.9; 43.5; 42.5; 87.0; 77.9; 64.3 | — |
| SECONDARY Daratumumab Serum Concentrations |
334.1819; 310.7272; 277.6708; 332.9353; 321.6084; 275.1521 | — |
| SECONDARY Percentage of Participants Anti Drug Antibody (ADA) by Positivity |
0.00; 6.3; 0.00; 0.00; 5.6; 0.00 | — |
Eligibility Criteria
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/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03098550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.