A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

March 12, 2024 updated by: Bristol-Myers Squibb

A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

402

Phase

  • Phase 2
  • 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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0007
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Local Institution - 0011
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0005
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0006
  • France
      • Marseille, France, 13385
        • Local Institution - 0018
      • Toulouse, France, 31059
        • Local Institution - 0019
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Local Institution - 0015
    • Paris
      • Villejuif, Paris, France, 94800
        • Local Institution - 0014
  • Spain
      • Madrid, Spain, 28040
        • Local Institution - 0022
      • Madrid, Spain, 28050
        • Local Institution - 0023
    • Andalucía
      • Málaga, Andalucía, Spain, 29010
        • Local Institution - 0024
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28009
        • Local Institution - 0025
  • Switzerland
      • Basel, Switzerland, 4031
        • Local Institution - 0012
      • Genève, Switzerland, 1211
        • Local Institution - 0020
    • Sankt Gallen
      • st.Gallen, Sankt Gallen, Switzerland, 9007
        • Local Institution - 0021
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0010
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0001
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 0003

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 a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
  • Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
  • Participants must have experienced radiographically documented progressive disease on or after the most recent therapy

Exclusion Criteria:

  • An active, known or suspected autoimmune disease
  • Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
  • Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
  • Untreated central nervous system (CNS) metastases or leptomeningeal metastasis

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 1: BMS-986408 Monotherapy
Drug: BMS-986408
Specified dose on specified days
Experimental: Part 2: BMS-986408 in combination with nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986408
Specified dose on specified days
Experimental: Part 2: BMS-986408 in combination with nivolumab and ipilimumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: BMS-986408
Specified dose on specified days
Experimental: Part 2: BMS-986408 in combination with nivolumab and chemotherapy
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986408
Specified dose on specified days
Biological: Platinum-doublet chemotherapy
Specified dose on specified days
Other Names:
  • PDCT
  • carbplatin, paclitaxel, pemetrexed, cisplatin
Experimental: Part 2: BMS-986408 in combination with rabeprazole
Drug: BMS-986408
Specified dose on specified days
Drug: Rabeprazole
Specified dose on specified days
Experimental: Part 3: BMS-986408 in combination with nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986408
Specified dose on specified days
Experimental: Part 3: BMS-986408 in combination with nivolumab and chemotherapy
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986408
Specified dose on specified days
Biological: Platinum-doublet chemotherapy
Specified dose on specified days
Other Names:
  • PDCT
  • carbplatin, paclitaxel, pemetrexed, cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Dose-Limiting Toxicities (DLTs)
Time Frame: Up to 28 days
Up to 28 days
Number of participants with Adverse Events (AEs)
Time Frame: Up to 29 months
Up to 29 months
Number of deaths
Time Frame: Up to 50 months
Up to 50 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum concentration (Cmax)
Time Frame: Up to 27 months
Up to 27 months
Time of maximum observed concentration (Tmax)
Time Frame: Up to 27 months
Up to 27 months
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T))
Time Frame: Up to 27 months
Up to 27 months
Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to 50 months
Up to 50 months
Duration of Response (DOR) assessed by RECIST v1.1
Time Frame: Up to 50 months
Up to 50 months

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 2, 2022

Primary Completion (Estimated)

October 14, 2025

Study Completion (Estimated)

October 14, 2025

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA099-003

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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