A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors

Last updated: May 7, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

BMS-986360

Docetaxel

Capecitabine

Clinical Study ID

NCT05625412
IM043-004
2022-500930-27
  • Ages > 18
  • All Genders

Study Summary

The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants in Part 1 must have histologic or cytologic confirmation of non-smallcell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamouscell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renalcell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), orsarcoma, that is advanced (metastatic, recurrent, and/or unresectable) withmeasurable disease per RECIST v1.1. In Part 2, only participants with histologicconfirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 areeligible.

  • In Part 2, archival biopsy collected within 3 months of screening with nointervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of 20 freshly cut unstained FFPE slides with an associated pathological report) orfresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional atprogression. Therefore, the participant in Part 2 must have a suitable tumor lesionfor the biopsy procedure, as judged by the investigator, in order to be eligible forthe study.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

  • Participants resistant/refractory to or intolerant of existing standard therapiesknown to provide clinical benefit (in addition, participants with NSCLC must beresistant or refractory to anti-PD-(L)1-based immunotherapy)

Exclusion

Exclusion Criteria:

  • Participants with primary central nervous system (CNS) disease, or tumors with CNSmetastases as the only disease site, will be excluded. Participants with controlledbrain metastases, however, will be allowed to enroll. Controlled brain metastasesare defined as no radiographic progression for at least 4 weeks following radiationand/or surgical treatment (or 4 weeks of observation if no intervention isclinically indicated), no longer taking steroids for at least 2 weeks prior to firstdose of study intervention, and with no new or progressive neurological signs andsymptoms.

  • Participants with a condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressivemedications within 30 days of randomization. Inhaled or topical steroids and adrenalreplacement steroid doses > 10 mg daily prednisone equivalent are permitted in theabsence of active autoimmune disease.

  • Participants with concurrent malignancy or history of prior malignancy active within 2 years (except history of early-stage basal/squamous cell skin cancer ornon-invasive or in situ cancers who have undergone definitive treatment) areexcluded unless treatment was completed at least 2 years before randomization andthe participant has no evidence of disease.

  • Participants with NSCLC with known or not tested for epidermal growth factorreceptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600Emutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1)translocations sensitive to available targeted inhibitor therapy

Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 220
Treatment Group(s): 4
Primary Treatment: BMS-986360
Phase: 1
Study Start date:
December 09, 2022
Estimated Completion Date:
July 30, 2027

Connect with a study center

  • Hospital Británico de Buenos Aires

    Ciudad autónoma de Buenos Aires, Buenos Aires 1280
    Argentina

    Active - Recruiting

  • Local Institution - 0033

    Ciudad autónoma de Buenos Aires, Buenos Aires 1280
    Argentina

    Site Not Available

  • Local Institution - 0032

    ABB, Ciudad Autónoma De Buenos Aires C1199ABB
    Argentina

    Site Not Available

  • Clinica Adventista Belgrano

    Caba, Ciudad Autónoma De Buenos Aires C1430EGF
    Argentina

    Active - Recruiting

  • Local Institution - 0030

    Caba, Ciudad Autónoma De Buenos Aires C1430EGF
    Argentina

    Site Not Available

  • Instituto Alexander Fleming

    Ciudad Autónoma de Buenos Aires, 1426
    Argentina

    Active - Recruiting

  • Local Institution - 0031

    Ciudad Autónoma de Buenos Aires, 1426
    Argentina

    Site Not Available

  • Local Institution - 0010

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • St Vincent's Hospital - The Kinghorn Cancer Center

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • GenesisCare North Shore

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Local Institution - 0061

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Gallipoli Medical Research Foundation

    Brisbane, Queensland 4120
    Australia

    Active - Recruiting

  • Gallipoli Medical Research Ltd

    Brisbane, Queensland 4120
    Australia

    Active - Recruiting

  • Local Institution - 0008

    Brisbane, Queensland 4120
    Australia

    Site Not Available

  • Frankston Hospital

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • Local Institution - 0063

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Local Institution - 0062

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Local Institution - 0003

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Local Institution - 0005

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G1Z5
    Canada

    Active - Recruiting

  • Bradfordhill

    Santiago, Región Metropolitana De Santiago 8420383
    Chile

    Active - Recruiting

  • FALP

    Santiago, Región Metropolitana De Santiago 7500921
    Chile

    Active - Recruiting

  • Fundacion Arturo Lopez Perez (FALP)

    Santiago, Región Metropolitana De Santiago 7500921
    Chile

    Active - Recruiting

  • Local Institution - 0034

    Santiago, Región Metropolitana De Santiago 8420383
    Chile

    Site Not Available

  • Local Institution - 0035

    Santiago, Región Metropolitana De Santiago 8330032
    Chile

    Site Not Available

  • Local Institution - 0047

    Santiago, Región Metropolitana De Santiago 7500921
    Chile

    Site Not Available

  • Pontificia Universidad Catolica de Chile

    Santiago, Región Metropolitana De Santiago 8330032
    Chile

    Active - Recruiting

  • Institut Paoli-Calmettes

    Marseille, Provence-Alpes-Côte-d'Azur 13273
    France

    Active - Recruiting

  • Local Institution - 0049

    Marseille, Provence-Alpes-Côte-d'Azur 13273
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, Val-de-Marne 94800
    France

    Active - Recruiting

  • Local Institution - 0052

    Villejuif, Val-de-Marne 94800
    France

    Site Not Available

  • Institut Curie

    Paris, 75248
    France

    Active - Recruiting

  • Local Institution - 0048

    Paris, 75248
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Active - Recruiting

  • Local Institution - 0050

    Toulouse, 31059
    France

    Site Not Available

  • Humanitas

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Local Institution - 0057

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Local Institution - 0058

    Rome, Roma 00144
    Italy

    Site Not Available

  • Istituto di Candiolo

    Candiolo, Torino 10060
    Italy

    Active - Recruiting

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino 10060
    Italy

    Active - Recruiting

  • Local Institution - 0059

    Candiolo, Torino 10060
    Italy

    Site Not Available

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128
    Italy

    Active - Recruiting

  • Local Institution - 0065

    Padova, 35128
    Italy

    Site Not Available

  • Local Institution - 0036

    Mexico City, Distrito Federal 14080
    Mexico

    Site Not Available

  • Local Institution - 0038

    Mexico City, Distrito Federal 03100
    Mexico

    Site Not Available

  • Local Institution - 0041

    Zapopan, Jalisco 45070
    Mexico

    Site Not Available

  • Local Institution - 0039

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Local Institution - 0037

    Puebla, 72424
    Mexico

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Active - Recruiting

  • Local Institution - 0053

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Site Not Available

  • Local Institution - 0054

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad De 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad De 28034
    Spain

    Active - Recruiting

  • Local Institution - 0055

    Madrid, Madrid, Comunidad De 28034
    Spain

    Site Not Available

  • Local Institution - 0056

    Madrid, Madrid, Comunidad De 28041
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Local Institution - 0064

    Sevilla, 41013
    Spain

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Local Institution - 0019

    Los Angeles, California 90048
    United States

    Site Not Available

  • Local Institution - 0029

    Los Angeles, California 90025
    United States

    Site Not Available

  • Local Institution - 0051

    Los Angeles, California 90067
    United States

    Site Not Available

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

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Local Institution - 0067

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • University of Hawaii Cancer Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Local Institution - 0026

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Ochsner Medical Center - Jefferson Highway

    New Orleans, Louisiana 70121
    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

  • Carolina BioOncology Institute

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Local Institution - 0018

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Local Institution - 0028

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology Nashville

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Local Institution - 0027

    San Antonio, Texas 78229
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Local Institution - 0046

    West Valley City, Utah 84119
    United States

    Site Not Available

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

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