A Phase Ib/II Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer
Study Identifier:
CA115-001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
N/A
Terminated/Withdrawn
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Study Summary
To evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female & Male
Age
18+ years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn
Requirements information
Inclusion criteria
- Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have a life expectancy of at least 3 months at the time of first dose.
- Principal inclusion criteria:
- Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Participants must have a life expectancy of at least 3 months at the time of first dose.
Exclusion criteria
- Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
- Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
- Participants with an active, known, or suspected autoimmune disease.
- Other protocol-defined inclusion/exclusion criteria apply.
- Untreated symptomatic central nervous system metastases or leptomeningeal metastases
- Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts
- Participants with an active, known, or suspected autoimmune disease. Other protocol-defined inclusion/exclusion criteria apply
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Manish Sharma
Status
Recruitment Complete
Condition(s) Treated at Site
Solid Tumor
Non-Small Cell Lung Cancer