A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Last updated: January 3, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Adenocarcinoma

Melanoma

Esophageal Disorders

Treatment

BMS-986340

BMS-936558-01

Docetaxel

Clinical Study ID

NCT04895709
CA052-002
U1111-1265-4508
2021-001188-26
2023-503651-10
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarkeranalysis

  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bonelesion biopsies are not acceptable.

  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

  • Radiographically documented progressive disease on or after the most recent therapy

  • Received standard-of-care therapies, (except for Part 1C, where participants withprior docetaxel use for the advanced/metastatic setting will be excluded), includingan available programmed death (ligand)-1 inhibitor known to be effective in thetumor type for which they are being evaluated

  • Advanced or metastatic disease and have received, be refractory to, not be acandidate for, or be intolerant of existing therapies known to provide clinicalbenefit for the condition of the participant

Exclusion

Exclusion Criteria:

  • Women who are pregnant or breastfeeding

  • Primary central nervous system (CNS) malignancy

  • Untreated CNS metastases

  • Leptomeningeal metastases

  • Concurrent malignancy requiring treatment or history of prior malignancy activewithin 2 years prior to the first dose of study treatment

  • Active, known, or suspected autoimmune disease

  • Condition requiring systemic treatment with either corticosteroids within 14 days orother immunosuppressive medications within 30 days of the first dose of studytreatment

  • Prior organ or tissue allograft

  • Uncontrolled or significant cardiovascular disease

  • Major surgery within 4 weeks of study drug administration

  • History of or with active interstitial lung disease or pulmonary fibrosis

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 905
Treatment Group(s): 3
Primary Treatment: BMS-986340
Phase: 1/2
Study Start date:
May 27, 2021
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Blacktown Hospital

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Local Institution - 0057

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Local Institution - 0058

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Local Institution - 0054

    Brisbane, Queensland 4102
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Active - Recruiting

  • Cabrini Hospital - Malvern

    Malvern, Victoria 3144
    Australia

    Active - Recruiting

  • Local Institution - 0053

    Malvern, Victoria 3144
    Australia

    Active - Recruiting

  • Local Institution - 0055

    Melbourne, Victoria 3065
    Australia

    Active - Recruiting

  • St Vincent's Hospital

    Melbourne, Victoria 3065
    Australia

    Active - Recruiting

  • Local Institution - 0056

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • One Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta T6X 1E8
    Canada

    Active - Recruiting

  • Local Institution - 0027

    Edmonton, Alberta T6X 1E8
    Canada

    Active - Recruiting

  • BC Cancer Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Local Institution - 0030

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Hamilton Health Sciences-Juravinski Cancer Centre

    Hamilton, Ontario L8V5C2
    Canada

    Active - Recruiting

  • Local Institution - 0029

    Hamilton, Ontario L8V5C2
    Canada

    Site Not Available

  • Local Institution - 0009

    Toronto, Ontario M5G 2M9
    Canada

    Completed

  • Centre Hospitalier de luniversite de Montreal

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • Local Institution - 0015

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • Local Institution

    Montréal, Quebec H2X 3E4
    Canada

    Site Not Available

  • Local Institution - 0016

    Ottawa, K1H 8L6
    Canada

    Active - Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8L6
    Canada

    Active - Recruiting

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg 89081
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit

    Dresden, 01307
    Germany

    Active - Recruiting

  • Local Institution - 0018

    Essen, 45147
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • Universitaetsklinikum Wuerzburg

    Wuerzburg, 97078
    Germany

    Active - Recruiting

  • Local Institution

    Würzburg, 97078
    Germany

    Site Not Available

  • Local Institution - 0036

    Petah Tikva, HaMerkaz 4941492
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, HaMerkaz 4941492
    Israel

    Active - Recruiting

  • Local Institution - 0035

    Ramat Gan, HaMerkaz 5265601
    Israel

    Site Not Available

  • Local Institution - 0038

    Ramat Gan, HaMerkaz 5265601
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5265601
    Israel

    Active - Recruiting

  • Local Institution - 0039

    Haifa, HaTsafon 3109601
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, HaTsafon 3109601
    Israel

    Active - Recruiting

  • Local Institution - 0037

    Tel Aviv, Tell Abīb 6423906
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb 6423906
    Israel

    Active - Recruiting

  • Humanitas

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Istituto di Candiolo

    Candiolo, Torino 10060
    Italy

    Site Not Available

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

    Candiolo, Torino 10060
    Italy

    Active - Recruiting

  • Local Institution - 0033

    Candiolo, Torino 10060
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1

    Milan, 20133
    Italy

    Active - Recruiting

  • Local Institution

    Milano, 20133
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Napoli, 80131
    Italy

    Active - Recruiting

  • Local Institution - 0034

    Napoli, 80131
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS Universita Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Active - Recruiting

  • Local Institution - 0040

    Roma, 00168
    Italy

    Site Not Available

  • ospedale le scotte-U.O.C. Immunoterapia Oncologica

    Siena, 53100
    Italy

    Active - Recruiting

  • Local Institution - 0064

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalucía 29010
    Spain

    Active - Recruiting

  • Local Institution - 0048

    Málaga, Andalucía 29010
    Spain

    Active - Recruiting

  • Institut Catalan d Oncologia (ICO) - Badalona

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Active - Recruiting

  • Local Institution - 0014

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Local Institution - 0049

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad De 28041
    Spain

    Active - Recruiting

  • Local Institution - 0047

    Madrid, Madrid, Comunidad De 28041
    Spain

    Active - Recruiting

  • Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD

    Madrid, 28040
    Spain

    Active - Recruiting

  • Local Institution - 0011

    Madrid, 28050
    Spain

    Active - Recruiting

  • Local Institution - 0013

    Madrid, 28040
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra-oNCOLOGY

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Local Institution - 0012

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Community Cancer Institute

    Clovis, California 93611
    United States

    Active - Recruiting

  • Local Institution

    La Jolla, California 92093
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Local Institution - 0002

    New York, New York 10065
    United States

    Completed

  • Memorial Sloan Kettering Nassau

    New York, New York 10065
    United States

    Completed

  • Providence Cancer Center Oncology and Hematology Care- Eastside

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Local Institution - 0052

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Local Institution - 0063

    Nashville, Tennessee 37067
    United States

    Site Not Available

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee 37067
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Local Institution - 0061

    Houston, Texas 77030
    United States

    Site Not Available

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