A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
NCT ID: NCT04943900
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
67 participants
INTERVENTIONAL
2021-08-09
2025-02-27
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 1A: Monotherapy (BMS-986416)
BMS-986416
Specified dose on specified days
Part 1B: Combination Therapy (BMS-986416 + Nivolumab)
BMS-986416
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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BMS-986416
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
* Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
* Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
* Disease amenable to serial biopsy
Exclusion Criteria
* Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
* Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)
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 - 0006
Atlanta, Georgia, United States
Local Institution - 0005
Baltimore, Maryland, United States
Local Institution - 0002
Hackensack, New Jersey, United States
Local Institution - 0013
Cleveland, Ohio, United States
Local Institution - 0003
Pittsburgh, Pennsylvania, United States
Local Institution - 0004
Houston, Texas, United States
Local Institution - 0021
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0027
ABB, Buenos Aires F.D., Argentina
Local Institution - 0022
CABA, Buenos Aires F.D., Argentina
Local Institution - 0043
Edegem, Antwerpen, Belgium
Local Institution - 0016
Ghent, Oost-Vlaanderen, Belgium
Local Institution - 0009
Edmonton, Alberta, Canada
Local Institution - 0008
Toronto, Ontario, Canada
Local Institution - 0001
Montreal, Quebec, Canada
Local Institution - 0025
Santiago, Santiago Metropolitan, Chile
Local Institution - 0026
Santiago, Santiago Metropolitan, Chile
Local Institution - 0024
Santiago, Santiago Metropolitan, Chile
Local Institution - 0010
Chuo-ku, Tokyo, Japan
Local Institution - 0020
Maastricht, Limburg, Netherlands
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA102-003
Identifier Type: -
Identifier Source: org_study_id
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