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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: Nivolumab

Drug: BMS-986416

Study type

Interventional

Funder types

Industry

Identifiers

NCT04943900

CA102-003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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