A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors

Program Status

Active, not recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

BMS-986416, Nivolumab

Tags

MSS/ MMRp

Comments

BMS-986416: anti LAG-3
Nivolumab: anti PD-1 (Opdivo), immunotherapy

Location Location Status
United States
Local Institution - 0006
Atlanta, Georgia 30322
Active, not recruiting
Local Institution - 0005
Baltimore, Maryland 21287
Active, not recruiting
Local Institution - 0002
Hackensack, New Jersey 07601
Active, not recruiting
Local Institution - 0013
Cleveland, Ohio 44106-1716
Active, not recruiting
Local Institution - 0003
Pittsburgh, Pennsylvania 15232
Active, not recruiting
Local Institution - 0004
Houston, Texas 77030
Active, not recruiting
Argentina
Local Institution - 0021
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
Active, not recruiting
Local Institution - 0027
ABB, Ciudad Autónoma De Buenos Aires C1199ABB
Active, not recruiting
Local Institution - 0022
Caba, Ciudad Autónoma De Buenos Aires C1430EGF
Active, not recruiting
Belgium
Local Institution - 0043
Edegem, Antwerpen 2650
Active, not recruiting
Local Institution - 0016
Gent, Oost-Vlaanderen 9000
Active, not recruiting
Canada
Local Institution - 0009
Edmonton, Alberta T6X 1E8
Active, not recruiting
Local Institution - 0008
Toronto, Ontario M5G 2M9
Active, not recruiting
Local Institution - 0001
Montréal, Quebec H2X 3H8
Active, not recruiting
Chile
Local Institution - 0025
Santiago, Región Metropolitana De Santiago 7500921
Active, not recruiting
Local Institution - 0026
Santiago, Región Metropolitana De Santiago 7620002
Active, not recruiting
Local Institution - 0024
Santiago, Región Metropolitana De Santiago 8420383
Active, not recruiting
Japan
Local Institution - 0010
Chuo-ku, Tokyo 104-0045
Active, not recruiting
Netherlands
Local Institution - 0020
Maastricht, Limburg 6229 HX
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
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

Exclusion Criteria:

Uncontrolled or significant cardiovascular disease
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)

Other protocol-defined inclusion/exclusion criteria apply

NCT ID

NCT04943900

Date Trial Added

2021-06-29

Updated Date

2024-04-01