A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors

Last updated: March 12, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

Nivolumab/relatlimab/rHuPH20

Bevacizumab

BMS-986482

Clinical Study ID

NCT06697197
CA236-0001
U1111-1309-0886
2024-516602-28
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All participants must have a histologically or cytologically confirmed, advanced,unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and havereceived, be refractory to, ineligible for, intolerant of, or refused existingtherapy(ies) known to provide clinical benefit for the condition of the participant.

  • Participant must be ≥ 18 years or the legal age of consent in the jurisdiction inwhich the study is taking place, inclusive, at the time of signing the ICF.

  • Participants in Part 1A may have NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma,urothelial carcinoma, PDAC, melanoma or breast cancer (TNBC and ER+HER2-).

  • Participants in Part 1B1 and 2B1 must have NSCLC and, if known, should havedocumented status for EGFR, KRAS, ALK, ROS1, RET, NTRK, MET exon 14 skippingmutations, and BRAF V600E.Participants must have received platinum-basedchemotherapy and anti-PD-(L)1 therapy, if eligible and available.

  • Participants in Parts 1B2, 2B2, and 1C must have cutaneous, acral, mucosal, orunknown primary melanoma. Participants with uveal/ocular melanoma are excluded.Participants must be melanoma 2L+.

  • Participants in Part 1B3 must have advanced or metastatic MSS-CRC.

  • Participants in Part 2A may have advanced solid tumors (advanced, unresectable, ormetastatic NSCLC, advanced, unresectable, hormone resistant ER+HER2-breast cancer orpancreatic adenocarcinoma [PDAC]) based on emerging data.

  • Participants in Part 2B3 must have advanced or metastatic MSS-CRC.

  • For all participants in Part 1C cohort, a tumor sample from a ("fresh") biopsy [corebiopsy (at least 4 passages recommended), punch biopsy, excisional biopsy orsurgical specimen] must be obtained (obtained within 1 month of the start of theScreening, if there are tumor sites that can be biopsied with acceptable clinicalrisk).

Exclusion

Exclusion Criteria:

  • History of life threatening immune mediated toxicity related to prior T-cell agonistor checkpoint inhibitor therapy, except those that are unlikely to re-occur withstandard countermeasures.

  • Any significant acute or chronic medical illness which would interfere with studyintervention or follow-up in the opinion of the investigator.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 413
Treatment Group(s): 4
Primary Treatment: Nivolumab/relatlimab/rHuPH20
Phase: 1/2
Study Start date:
February 17, 2025
Estimated Completion Date:
January 05, 2029

Connect with a study center

  • Local Institution - 0017

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • Local Institution - 0022

    Copenhagen, Hovedstaden DK-2100
    Denmark

    Site Not Available

  • Local Institution - 0016

    Marseille, Bouches-du-Rhône 13385
    France

    Site Not Available

  • Local Institution - 0012

    Villejuif, Val-de-Marne 94800
    France

    Site Not Available

  • Local Institution - 0038

    Athens, Attikí 11527
    Greece

    Site Not Available

  • Local Institution - 0039

    Thessaloniki, Thessaloníki 564 29
    Greece

    Site Not Available

  • Local Institution - 0037

    Milan, Lombardia 20133
    Italy

    Site Not Available

  • Local Institution - 0036

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Local Institution - 0018

    Amsterdam, Noord-Holland 1066 CX
    Netherlands

    Site Not Available

  • Local Institution - 0028

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Local Institution - 0033

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Local Institution - 0035

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Local Institution - 0034

    Madrid, 28050
    Spain

    Site Not Available

  • Local Institution - 0023

    Solna, Stockholms Län [se-01] 171 64
    Sweden

    Site Not Available

  • Local Institution - 0005

    Irvine, California 92612
    United States

    Site Not Available

  • Local Institution - 0030

    Los Angeles, California 90025
    United States

    Site Not Available

  • Local Institution - 0008

    Aurora, Colorado 80045
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0009

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Local Institution - 0007

    Lake Success, New York 11042
    United States

    Site Not Available

  • Northwell Health/ RJ Zuckerberg Cancer Center

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Local Institution - 0011

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Local Institution - 0010

    Seattle, Washington 98109
    United States

    Site Not Available

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