Phase 2
Completed N=292
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
Source: ClinicalTrials.gov NCT02598960 ↗Enrolled (actual)
292
Serious AEs
63.7%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths — 4; 6; 4; 6 Participants
Summary
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths |
4; 6; 4; 6; 9; 3 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests |
1; 2; 0; 2; 2; 0 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in Specific Liver Tests |
0; 1; 1; 0; 1; 0 | — |
| SECONDARY Best Overall Response |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Overall Response Rate |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
3.48; 1.74; 2.66; 1.64; 1.84; 1.64 | — |
| SECONDARY Duration of Response |
20.70; 30.10; NA; NA; NA | — |
| SECONDARY Number of Participants With Anti-Drug Antibody Response |
1; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- For Dose Escalation:
- Subjects with any previously treated advanced (metastatic or refractory) solid tumor
- For Cohort Expansion:
- Subjects must have a previously treated advanced solid tumor to be eligible
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
- Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Exclusion Criteria
- Known central nervous system metastases or central nervous system as the only source of disease
- Other concomitant malignancies (with some exceptions per protocol)
- Active, known or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- History of active or chronic hepatitis (e.g. Hep B or C)
- Impaired liver or bone marrow function
- Major surgery less than 1 month before start of the study
Data sourced from ClinicalTrials.gov (NCT02598960). 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.