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

NCT04895709 · Bristol-Myers Squibb
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Official title
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
About this study
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 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
Enrollment target: 949 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-05-27
Estimated completion: 2028-07-07
Last updated: 2026-04-13
Interventions
Drug: BMS-986340Drug: BMS-936558-01Drug: Docetaxel
Primary outcomes
  • Incidence of adverse events (AEs) (Up to 120 weeks)
  • Incidence of serious adverse events (SAEs) (Up to 120 weeks)
  • Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria (Up to 120 weeks)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (48)
Community Cancer InstituteRecruiting
Clovis, California, United States
USC/Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
University of IowaRecruiting
Iowa City, Iowa, United States
John Theurer Cancer CenterRecruiting
Hackensack, New Jersey, United States
Local Institution - 0006Completed
New York, New York, United States
Local Institution - 0002Completed
New York, New York, United States
Providence Cancer Center Oncology and Hematology Care- EastsideRecruiting
Portland, Oregon, United States
Local Institution - 0063Not Yet Recruiting
Nashville, Tennessee, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Houston Methodist HospitalRecruiting
Houston, Texas, United States
Blacktown HospitalRecruiting
Blacktown, New South Wales, Australia
Liverpool HospitalRecruiting
Liverpool, New South Wales, Australia
Princess Alexandra HospitalRecruiting
Brisbane, Queensland, Australia
Cabrini Hospital - MalvernRecruiting
Malvern, Victoria, Australia
St Vincent's HospitalRecruiting
Melbourne, Victoria, Australia
One Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
Cross Cancer InstituteRecruiting
Edmonton, Alberta, Canada
BC Cancer VancouverRecruiting
Vancouver, British Columbia, Canada
Hamilton Health Sciences-Juravinski Cancer CentreRecruiting
Hamilton, Ontario, Canada
Local Institution - 0009Completed
Toronto, Ontario, Canada
Centre Hospitalier de luniversite de MontrealRecruiting
Montreal, Quebec, Canada
The Ottawa Hospital Cancer CentreRecruiting
Ottawa, Canada
Local Institution - 0067Not Yet Recruiting
Beijing, Beijing Municipality, China
Universitaetsklinikum UlmRecruiting
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial UnitRecruiting
Dresden, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Universitatsklinikum FrankfurtRecruiting
Frankfurt, Germany
Universitaetsklinikum WuerzburgRecruiting
Würzburg, Germany
Rabin Medical CenterRecruiting
Petah Tikva, Central District, Israel
Local Institution - 0035Withdrawn
Ramat Gan, Central District, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Central District, Israel
Rambam Health Care CampusRecruiting
Haifa, Northern District, Israel
Sourasky Medical CenterRecruiting
Tel Aviv, Tell Abīb, Israel
HumanitasRecruiting
Rozzano, Milano, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'OncologiaRecruiting
Candiolo, Torino, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1Recruiting
Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione PascaleRecruiting
Naples, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRecruiting
Roma, Italy
ospedale le scotte-U.O.C. Immunoterapia OncologicaRecruiting
Siena, Italy
National Cancer Center Hospital EastRecruiting
Kashiwa, Chiba, Japan
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Andalusia, Spain
Institut Catalan d Oncologia (ICO) - BadalonaRecruiting
Badalona, Barcelona [Barcelona], Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJDRecruiting
Madrid, Spain
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCCRecruiting
Madrid, Spain
Clinica Universidad de Navarra-oNCOLOGYRecruiting
Pamplona, Spain
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors · TrialPath