Phase 1 Study of BMS-986416 with and without Nivolumab in Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors

• Registration Number: JPRN-jRCT2031210475
• Lead Sponsor: Perez Raymond

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 134

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified