RecruitingPhase 1Phase 2NCT04895709

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

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Sponsor

Bristol-Myers Squibb

Enrollment

949 participants

Start Date

May 27, 2021

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer Gastric/Gastroesophageal Junction Adenocarcinoma Microsatellite Stable Colorectal Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing a new experimental drug called BMS-986340 either alone or in combination with nivolumab (an immunotherapy) or docetaxel (a chemotherapy) in patients with advanced solid tumors that have progressed despite standard treatments. **You may be eligible if...** - You have an advanced or metastatic solid tumor (not a primary brain tumor) - Your cancer has progressed on standard therapies including an immunotherapy checkpoint inhibitor (if one is known to help your tumor type) - You have at least one measurable tumor and one tumor accessible for biopsy - You have good performance status (ECOG 0–1) - You have not had prior docetaxel in the advanced/metastatic setting (for the docetaxel combination group) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have untreated or leptomeningeal brain metastases - You have active autoimmune disease - You are on systemic steroids or immunosuppressants - You have had a prior organ or tissue transplant - You have uncontrolled heart disease or interstitial lung disease - You have had major surgery within 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986340

Specified dose on specified days

DRUGBMS-936558-01

Specified dose on specified days

DRUGDocetaxel

Specified dose on specified days

Locations(48)

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

University of Iowa

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

Providence Cancer Center Oncology and Hematology Care- Eastside

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

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

Naples, 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 Díaz-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

View Full Details on ClinicalTrials.gov

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NCT04895709

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