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

NCT ID: NCT04943900

Last Updated: 2025-04-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2025-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A: Monotherapy (BMS-986416)

Group Type EXPERIMENTAL

BMS-986416

Intervention Type DRUG

Specified dose on specified days

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

Group Type EXPERIMENTAL

BMS-986416

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986416

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-936558 Opdivo

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Local Institution - 0005

Baltimore, Maryland, United States

Site Status

Local Institution - 0002

Hackensack, New Jersey, United States

Site Status

Local Institution - 0013

Cleveland, Ohio, United States

Site Status

Local Institution - 0003

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0004

Houston, Texas, United States

Site Status

Local Institution - 0021

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution - 0027

ABB, Buenos Aires F.D., Argentina

Site Status

Local Institution - 0022

CABA, Buenos Aires F.D., Argentina

Site Status

Local Institution - 0043

Edegem, Antwerpen, Belgium

Site Status

Local Institution - 0016

Ghent, Oost-Vlaanderen, Belgium

Site Status

Local Institution - 0009

Edmonton, Alberta, Canada

Site Status

Local Institution - 0008

Toronto, Ontario, Canada

Site Status

Local Institution - 0001

Montreal, Quebec, Canada

Site Status

Local Institution - 0025

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0026

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0024

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0010

Chuo-ku, Tokyo, Japan

Site Status

Local Institution - 0020

Maastricht, Limburg, Netherlands

Site Status

Countries

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United States Argentina Belgium Canada Chile Japan Netherlands

Related Links

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Other Identifiers

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CA102-003

Identifier Type: -

Identifier Source: org_study_id

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