A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
NCT ID: NCT05407675
Last Updated: 2025-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
68 participants
INTERVENTIONAL
2022-08-02
2025-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: BMS-986408 Monotherapy
BMS-986408
Specified dose on specified days
Part 2: BMS-986408 in combination with nivolumab
BMS-986408
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2: BMS-986408 in combination with nivolumab and ipilimumab
BMS-986408
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 2: BMS-986408 in combination with nivolumab and chemotherapy
BMS-986408
Specified dose on specified days
Nivolumab
Specified dose on specified days
Platinum-doublet chemotherapy
Specified dose on specified days
Part 2: BMS-986408 in combination with rabeprazole
BMS-986408
Specified dose on specified days
Rabeprazole
Specified dose on specified days
Part 3: BMS-986408 in combination with nivolumab
BMS-986408
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 3: BMS-986408 in combination with nivolumab and chemotherapy
BMS-986408
Specified dose on specified days
Nivolumab
Specified dose on specified days
Platinum-doublet chemotherapy
Specified dose on specified days
Interventions
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BMS-986408
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Platinum-doublet chemotherapy
Specified dose on specified days
Rabeprazole
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
* Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
* Participants must have experienced radiographically documented progressive disease on or after the most recent therapy
Exclusion Criteria
* Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
* Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
* Untreated central nervous system (CNS) metastases or leptomeningeal metastasis
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0010
Boston, Massachusetts, United States
Local Institution - 0001
Hackensack, New Jersey, United States
Local Institution - 0003
Houston, Texas, United States
Local Institution - 0007
Edmonton, Alberta, Canada
Local Institution - 0011
Hamilton, Ontario, Canada
Local Institution - 0005
Ottawa, Ontario, Canada
Local Institution - 0006
Toronto, Ontario, Canada
Local Institution - 0015
Bordeaux, Aquitaine, France
Local Institution - 0014
Villejuif, Paris, France
Local Institution - 0018
Marseille, , France
Local Institution - 0019
Toulouse, , France
Local Institution - 0024
Málaga, Andalusia, Spain
Local Institution - 0025
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0022
Madrid, , Spain
Local Institution - 0023
Madrid, , Spain
Local Institution - 0021
Sankt Gallen, Canton of St. Gallen, Switzerland
Local Institution - 0012
Basel, , Switzerland
Local Institution - 0020
Geneva, , Switzerland
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA099-003
Identifier Type: -
Identifier Source: org_study_id
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