Phase 2
Completed N=235
An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
Malignant Solid Tumor
Source: ClinicalTrials.gov NCT02754141 ↗
Enrolled (actual)
235
Serious AEs
47.8%
Results posted
Apr 2023
Primary outcomePrimary: Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths. — 7; 4; 3; 4 Participants
Summary
The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths. |
7; 4; 3; 4; 5; 7 | — |
| SECONDARY Number of Participants With a Best Overall Response (BOR) at Week 24 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With an Objective Response Rate (ORR) at Week 24 |
0; 0; 0; 0; 0; 8.3 | — |
| SECONDARY Progression Free Survival Rate (PFSR) at Week 24 |
7.1; 8.3; 0; 11.1; 16.7; 83.3 | — |
| SECONDARY Median Duration of Response (DOR) |
17.40; 5.70; 9.30; 2.10; 24.40; 3.90 | — |
| SECONDARY Cmax |
30.6524; 94.9210; 218.0423; 499.5178; 28.8892; 64.3400 | — |
| SECONDARY Tmax |
2.409; 0.933; 2.992; 2.700; 1.00; 2.942 | — |
| SECONDARY AUC (0-T) |
1417.4834; 2565.0489; 9362.9155; 30716.0037; 1225.3679; 3418.8393 | — |
| SECONDARY AUC (Tau) |
1417.4834; 34198.6293; 1307.7132; 3546.1659; 9139.4853; 23533.0706 | — |
| SECONDARY Ctau |
1.9173; 82.2225; 0.8999; 41.0567; 25.9755; 74.8859 | — |
| SECONDARY Mean Change From Baseline in CD73 Assays |
-33.790; -103.700; -204.710; -3.220; -33.790; -103.700 | — |
| SECONDARY Number of Participants With a Positive Anti-drug Antibody (ADA) Test. |
5; 4; 8; 3; 2; 5 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Acceptable lab testing results
- Allow biopsies
Exclusion Criteria
- Central nervous system (CNS) tumors
- Uncontrolled or significant cardiovascular diseases
- Active or known autoimmune disease
- Organ transplant
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02754141). 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.