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

April 7, 2025 updated by: Bristol-Myers Squibb

A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0021
    • Ciudad Autónoma De Buenos Aires
      • ABB, Ciudad Autónoma De Buenos Aires, Argentina, C1199ABB
        • Local Institution - 0027
      • Caba, Ciudad Autónoma De Buenos Aires, Argentina, C1430EGF
        • Local Institution - 0022
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Local Institution - 0043
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Local Institution - 0016
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6X 1E8
        • Local Institution - 0009
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0008
    • Quebec
      • Montréal, Quebec, Canada, H2X 3H8
        • Local Institution - 0001
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7620002
        • Local Institution - 0026
    • Región Metropolitana De Santiago
      • Santiago, Región Metropolitana De Santiago, Chile, 7500921
        • Local Institution - 0025
      • Santiago, Región Metropolitana De Santiago, Chile, 8420383
        • Local Institution - 0024
  • Japan
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Local Institution - 0010
  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Local Institution - 0020
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0006
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0005
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0002
    • Ohio
      • Cleveland, Ohio, United States, 44106-1716
        • Local Institution - 0013
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0003
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 0004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A: Monotherapy (BMS-986416)
Drug: BMS-986416
Specified dose on specified days
Experimental: Part 1B: Combination Therapy (BMS-986416 + Nivolumab)
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986416
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 100 days after the last treatment of study intervention(s)
Up to 100 days after the last treatment of study intervention(s)
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 100 days after the last treatment of study intervention(s)
Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to 100 days after the last treatment of study intervention(s)
Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to discontinuation
Time Frame: Up to 100 days after the last treatment of study intervention(s)
Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to death
Time Frame: Up to 100 days after the last treatment of study intervention(s)
Up to 100 days after the last treatment of study intervention(s)
Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)
Time Frame: Up to 100 days after the last treatment of study intervention(s)
Up to 100 days after the last treatment of study intervention(s)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed serum concentration (Cmax) of BMS-986416
Time Frame: Up to 100 days after the last treatment of study intervention(s)
Up to 100 days after the last treatment of study intervention(s)
Time of maximum observed serum concentration (Tmax) of BMS-986416
Time Frame: Up to 100 days after the last treatment of study intervention(s)
Up to 100 days after the last treatment of study intervention(s)
Trough observed serum concentration (Ctrough) of BMS-986416
Time Frame: Up to 100 days after the last treatment of study intervention(s)
Up to 100 days after the last treatment of study intervention(s)
Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment
Time Frame: Up to 2 years
Up to 2 years
Duration of Response (DOR) using RECIST 1.1 per Investigator assessment
Time Frame: Up to 2 years
Up to 2 years
Incidence of clinically significant changes in ECG parameters: QTcF
Time Frame: Up to 100 days after the last treatment of study intervention(s)
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Up to 100 days after the last treatment of study intervention(s)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2021

Primary Completion (Actual)

February 27, 2025

Study Completion (Actual)

February 27, 2025

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA102-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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