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Trial ID CA102-003  |   NCT04943900

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

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

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Key Eligibility 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: - 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part 1A: Monotherapy (BMS-986416)

ASSIGNED INTERVENTION
  • Drug: BMS-986416

Study Arms

Experimental: Part 1B: Combination Therapy (BMS-986416 + Nivolumab)

ASSIGNED INTERVENTION
  • Drug: BMS-986416, Nivolumab

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