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

Last updated: November 20, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

Ipilimumab

Rabeprazole

BMS-986408

Clinical Study ID

NCT05407675
CA099-003
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with a histologically or cytologically confirmed, advanced,unresectable/metastatic, solid malignancy of any histology measurable by ResponseEvaluation Criteria in Solid Tumors (RECIST) v1.1

  • Participants who have received, been refractory to, ineligible for, or intolerant ofexisting therapy(ies) known to provide clinical benefit for the condition of theparticipant

  • Participants with melanoma should have documentation of mutation status for B-typeRaf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)

  • Participants must have experienced radiographically documented progressive diseaseon or after the most recent therapy

Exclusion

Exclusion Criteria:

  • An active, known or suspected autoimmune disease

  • Conditions requiring systemic treatment with either corticosteroids within 14 daysor other immunosuppressive medications within 30 days of the first dose of studytreatment

  • Current or recent gastrointestinal disease or gastrointestinal surgery that couldimpact the absorption of study drug

  • Untreated central nervous system (CNS) metastases or leptomeningeal metastasis

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 101
Treatment Group(s): 5
Primary Treatment: Ipilimumab
Phase: 1/2
Study Start date:
August 02, 2022
Estimated Completion Date:
October 14, 2025

Connect with a study center

  • Local Institution - 0007

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Local Institution - 0011

    Hamilton, Ontario L8V5C2
    Canada

    Site Not Available

  • Local Institution - 0005

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Local Institution - 0006

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine 33076
    France

    Active - Recruiting

  • Local Institution - 0015

    Bordeaux, Aquitaine 33076
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, Paris 94800
    France

    Active - Recruiting

  • Local Institution - 0014

    Villejuif, Paris 94800
    France

    Site Not Available

  • Centre Leon Berard

    Lyon Cedex08, Rhône-Alpes 69373
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone-CEPCM

    Marseille, 13385
    France

    Active - Recruiting

  • Local Institution - 0018

    Marseille, 13385
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • Local Institution - 0019

    Toulouse, 31059
    France

    Site Not Available

  • Local Institution - 0024

    Málaga, Andalucía 29010
    Spain

    Site Not Available

  • Local Institution - 0025

    Madrid, Madrid, Comunidad De 28009
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Local Institution - 0022

    Madrid, 28040
    Spain

    Site Not Available

  • Local Institution - 0023

    Madrid, 28050
    Spain

    Site Not Available

  • Cantonal Hospital St.Gallen

    st.Gallen, Sankt Gallen 9007
    Switzerland

    Active - Recruiting

  • Local Institution - 0021

    st.Gallen, Sankt Gallen 9007
    Switzerland

    Site Not Available

  • Local Institution - 0012

    Basel, 4031
    Switzerland

    Site Not Available

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Local Institution - 0020

    Geneva, 1205
    Switzerland

    Site Not Available

  • Hôpitaux Universitaire de Genève

    Genève, 1211
    Switzerland

    Site Not Available

  • Local Institution - 0020

    Genève, 1211
    Switzerland

    Site Not Available

  • The Angeles Clinic and Research Institute - West Los Angeles Office

    Los Angeles, California 90025
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Local Institution - 0010

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0001

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Local Institution - 0003

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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