A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
NCT ID: NCT04895709
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
949 participants
INTERVENTIONAL
2021-05-27
2028-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1A: BMS-986340 Dose Escalation
BMS-986340
Specified dose on specified days
Part 2A: BMS-986340 Dose Expansion
BMS-986340
Specified dose on specified days
Part 1B: BMS-986340 + Nivolumab Dose Escalation
BMS-986340
Specified dose on specified days
BMS-936558-01
Specified dose on specified days
Part 2B: BMS-986340 + Nivolumab Dose Expansion
BMS-986340
Specified dose on specified days
BMS-936558-01
Specified dose on specified days
Part 1C: BMS-986340 + Docetaxel Dose Escalation
BMS-986340
Specified dose on specified days
Docetaxel
Specified dose on specified days
Part 1A-J: BMS-986340 Dose Escalation
BMS-986340
Specified dose on specified days
Part 1B-J: BMS-986340 + Nivolumab Dose Escalation
BMS-986340
Specified dose on specified days
BMS-936558-01
Specified dose on specified days
Interventions
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BMS-986340
Specified dose on specified days
BMS-936558-01
Specified dose on specified days
Docetaxel
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Community Cancer Institute
Clovis, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Local Institution - 0062
Iowa City, Iowa, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Local Institution - 0006
New York, New York, United States
Local Institution - 0002
New York, New York, United States
Local Institution - 0001
Portland, Oregon, United States
Local Institution - 0063
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
Blacktown Hospital
Blacktown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Cabrini Hospital - Malvern
Malvern, Victoria, Australia
St Vincent's Hospital
Melbourne, Victoria, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer Vancouver
Vancouver, British Columbia, Canada
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, Canada
Local Institution - 0009
Toronto, Ontario, Canada
Centre Hospitalier de luniversite de Montreal
Montreal, Quebec, Canada
The Ottawa Hospital Cancer Centre
Ottawa, , Canada
Local Institution - 0067
Beijing, Beijing Municipality, China
Local Institution - 0066
Jinan, Shandong, China
Local Institution - 0065
Hangzhou, Zhejiang, China
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
Dresden, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Rabin Medical Center
Petah Tikva, Central District, Israel
Local Institution - 0035
Ramat Gan, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Sourasky Medical Center
Tel Aviv, Tell Abīb, Israel
Humanitas
Rozzano, Milano, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, , Italy
ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena, , Italy
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Institut Catalan d Oncologia (ICO) - Badalona
Badalona, Barcelona [Barcelona], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Fundación Jiménez DÃaz-START Madrid-FJD
Madrid, , Spain
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC
Madrid, , Spain
Clinica Universidad de Navarra-oNCOLOGY
Pamplona, , Spain
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Uzair Chaudhary, Site 0032
Role: primary
Anthony El-Khoueiry, Site 0041
Role: primary
Carlos Becerra, Site 0050
Role: primary
Martin Gutierrez, Site 0007
Role: primary
Site 0063
Role: primary
Jordan Berlin, Site 0052
Role: primary
Maen Abdelrahim, Site 0061
Role: primary
Adnan Nagrial, Site 0057
Role: primary
Abhijit Pal, Site 0058
Role: primary
Aaron Hansen, Site 0054
Role: primary
Shehara Mendis, Site 0053
Role: primary
Melissa Moore, Site 0055
Role: primary
Muhammad Khattak, Site 0056
Role: primary
Quincy Chu, Site 0027
Role: primary
Anna Tinker, Site 0030
Role: primary
Sebastien Hotte, Site 0029
Role: primary
Rahima Jamal, Site 0015
Role: primary
John Hilton, Site 0016
Role: primary
Site 0067
Role: primary
Site 0066
Role: primary
Site 0065
Role: primary
Simon Laban, Site 0044
Role: primary
Martin Wermke, Site 0010
Role: primary
Stefan Kasper-Virchow, Site 0018
Role: primary
Martin Sebastian, Site 0020
Role: primary
Cyrus Sayehli, Site 0019
Role: primary
Salomon Stemmer, Site 0036
Role: primary
Tamar Beller, Site 0038
Role: primary
Ruth Perets, Site 0039
Role: primary
Ravit Geva, Site 0037
Role: primary
Matteo Simonelli, Site 0023
Role: primary
Vanesa Gregorc, Site 0033
Role: primary
Filippo De Braud, Site 0024
Role: primary
Paolo Ascierto, Site 0034
Role: primary
Gennaro Daniele, Site 0040
Role: primary
Michele Maio, Site 0025
Role: primary
Yasutoshi Kuboki, Site 0064
Role: primary
Javier Garcia Corbacho, Site 0048
Role: primary
Cinta Hierro Carbo, Site 0014
Role: primary
Elena Garralda Cabanas, Site 0049
Role: primary
Luis Paz-Ares Rodriguez, Site 0047
Role: primary
Victor Moreno Garcia, Site 0013
Role: primary
Emiliano Calvo, Site 0011
Role: primary
Ignacio Melero Bermejo, Site 0012
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-503651-10
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1265-4508
Identifier Type: OTHER
Identifier Source: secondary_id
CA052-002
Identifier Type: -
Identifier Source: org_study_id