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

Last updated: April 3, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cervical Cancer

Carcinoma

Digestive System Neoplasms

Treatment

BMS-986340

BMS-936558-01

Docetaxel

Clinical Study ID

NCT04895709
CA052-002
U1111-1265-4508
2023-503651-10
2021-001188-26
  • 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 biomarker analysis.

  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion 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 with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.

  • Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.

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 active within 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 or other immunosuppressive medications within 30 days of the first dose of study treatment.

  • 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: 949
Treatment Group(s): 3
Primary Treatment: BMS-986340
Phase: 1/2
Study Start date:
May 27, 2021
Estimated Completion Date:
July 07, 2028

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

  • Blacktown Hospital

    Blacktown 2175411, New South Wales 2155400 2148
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool 2159851, New South Wales 2155400 2170
    Australia

    Site Not Available

  • Local Institution - 0054

    Brisbane, Queensland 4102
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane 2174003, Queensland 2152274 4102
    Australia

    Site Not Available

  • 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

  • Cabrini Hospital - Malvern

    Malvern 2158952, Victoria 2145234 3144
    Australia

    Site Not Available

  • St Vincent's Hospital

    Melbourne 2158177, Victoria 2145234 3065
    Australia

    Site Not Available

  • Local Institution - 0056

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • One Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • One Clinical Research

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6X 1E8
    Canada

    Active - Recruiting

  • Local Institution - 0027

    Edmonton, Alberta T6X 1E8
    Canada

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton 5946768, Alberta 5883102 T6X 1E8
    Canada

    Site Not Available

  • BC Cancer Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Local Institution - 0030

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • BC Cancer Vancouver

    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
    Canada

    Site Not Available

  • 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

  • Hamilton Health Sciences-Juravinski Cancer Centre

    Hamilton 5969782, Ontario 6093943 L8V5C2
    Canada

    Site Not Available

  • Local Institution - 0009

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • 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

  • Centre Hospitalier de luniversite de Montreal

    Montreal 6077243, Quebec 6115047 H2X 0A9
    Canada

    Site Not Available

  • Local Institution - 0016

    Ottawa, K1H 8L6
    Canada

    Active - Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8L6
    Canada

    Active - Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa 6094817, K1H 8L6
    Canada

    Site Not Available

  • Local Institution - 0067

    Beijing, Beijing Municipality 100142
    China

    Site Not Available

  • Local Institution - 0067

    Beijing 1816670, Beijing Municipality 2038349 100142
    China

    Site Not Available

  • Local Institution - 0066

    Jinan, Shandong 250117
    China

    Site Not Available

  • Local Institution - 0066

    Jinan 1805753, Shandong 1796328 250117
    China

    Site Not Available

  • Local Institution - 0065

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Local Institution - 0065

    Hangzhou 1808926, Zhejiang 1784764 310022
    China

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg 89081
    Germany

    Active - Recruiting

  • Universitaetsklinikum Ulm

    Ulm 2820256, Baden-Wurttemberg 2953481 89081
    Germany

    Site Not Available

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

    Dresden, 01307
    Germany

    Active - Recruiting

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

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Local Institution - 0018

    Essen, 45147
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt 2925536, 60590
    Germany

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Wuerzburg, 97078
    Germany

    Site Not Available

  • Local Institution

    Würzburg, 97078
    Germany

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078
    Germany

    Active - Recruiting

  • Universitaetsklinikum Wuerzburg

    Würzburg 2805615, 97078
    Germany

    Site Not Available

  • Rabin Medical Center

    Petah Tikva, Central District 4941492
    Israel

    Active - Recruiting

  • Local Institution - 0035

    Ramat Gan, Central District 5265601
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, Central District 5265601
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva 293918, Central District 294904 4941492
    Israel

    Site Not Available

  • Local Institution - 0036

    Petah Tikva, HaMerkaz 4941492
    Israel

    Active - Recruiting

  • Local Institution - 0038

    Ramat Gan, HaMerkaz 5265601
    Israel

    Active - Recruiting

  • Local Institution - 0039

    Haifa, HaTsafon 3109601
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, Northern District 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

  • Sourasky Medical Center

    Tel Aviv 293397, Tell Abīb 6423906
    Israel

    Site Not Available

  • Humanitas

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Humanitas

    Rozzano 3168837, Milano 20089
    Italy

    Site Not Available

  • 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

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

    Candiolo 3180861, Torino 10060
    Italy

    Site Not Available

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

    Milan, 20133
    Italy

    Active - Recruiting

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

    Milan 3173435, 20133
    Italy

    Site Not Available

  • Local Institution

    Milano, 20133
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Local Institution - 0034

    Napoli, 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • 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

    Site Not Available

  • Local Institution - 0040

    Roma, 00168
    Italy

    Site Not Available

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

    Roma 8957247, 00168
    Italy

    Site Not Available

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

    Siena, 53100
    Italy

    Active - Recruiting

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

    Siena 3166548, 53100
    Italy

    Site Not Available

  • Local Institution - 0064

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa 1859924, Chiba 2113014 277-8577
    Japan

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Malaga, Andalucía 29010
    Spain

    Site Not Available

  • Local Institution - 0048

    Málaga, Andalucía 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga 2514256, Andalusia 2593109 29010
    Spain

    Site Not Available

  • 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

  • Institut Catalan d Oncologia (ICO) - Badalona

    Badalona 3129028, Barcelona [Barcelona] 08916
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Local Institution - 0049

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Local Institution - 0047

    Madrid, Madrid, Comunidad De 28041
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de 28041
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 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

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

    Madrid 3117735, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Clinica Universidad de Navarra-oNCOLOGY

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Local Institution - 0012

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra-oNCOLOGY

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • 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

  • Community Cancer Institute

    Clovis 5338122, California 5332921 93611
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • Hoag Memorial Hospital Presbyterian

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Local Institution - 0062

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • University of Iowa

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • John Theurer Cancer Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • 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

  • Local Institution - 0006

    New York, New York 10032
    United States

    Completed

  • Memorial Sloan Kettering Nassau

    New York, New York 10065
    United States

    Completed

  • Local Institution - 0002

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Local Institution - 0006

    New York 5128581, New York 5128638 10032
    United States

    Completed

  • Providence Cancer Center Oncology and Hematology Care- Eastside

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Local Institution - 0001

    Portland 5746545, Oregon 5744337 97213
    United States

    Site Not Available

  • Providence Cancer Center Oncology and Hematology Care- Eastside

    Portland 5746545, Oregon 5744337 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

  • Local Institution - 0063

    Nashville 4644585, Tennessee 4662168 37067
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Local Institution - 0061

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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