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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04895709
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, Germany, Israel, Italy, Japan, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, Triple Negative Breast Neoplasms
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Part 1A: BMS-986340 Dose Escalation

Experimental: Part 2A: BMS-986340 Dose Expansion

Experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation

Experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion

Experimental: Part 1C: BMS-986340 + Docetaxel Dose Escalation

Interventions

Drug: - BMS-986340

Specified dose on specified days

Drug: - BMS-936558-01

Specified dose on specified days

Drug: - Docetaxel

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Community Cancer Institute, Clovis, California

Status

Recruiting

Address

Community Cancer Institute

Clovis, California, 93611

Site Contact

Uzair Chaudhary, Site 0032

[email protected]

559-387-1600

USC/Norris Comprehensive Cancer Center, Los Angeles, California

Status

Recruiting

Address

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Site Contact

Anthony El-Khoueiry, Site 0041

[email protected]

323-865-3967

Hoag Memorial Hospital Presbyterian, Newport Beach, California

Status

Recruiting

Address

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Site Contact

Carlos Becerra, Site 0050

[email protected]

949-764-8222

University of Iowa, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa

Iowa City, Iowa, 52242

Site Contact

Yousef Zakharia, Site 0062

[email protected]

319-384-8076

John Theurer Cancer Center, Hackensack, New Jersey

Status

Recruiting

Address

John Theurer Cancer Center

Hackensack, New Jersey, 07601

Site Contact

Martin Gutierrez, Site 0007

[email protected]

551-996-5863

New York, New York

Status

Recruiting

Address

Columbia University Irving Medical Center

New York, New York, 10032

Site Contact

Ryan Moy, Site 0006

[email protected]

714-726-7966

Memorial Sloan Kettering Nassau, New York, New York

Status

Completed

Address

Memorial Sloan Kettering Nassau

New York, New York, 10065

Portland, Oregon

Status

Recruiting

Address

Providence Cancer Center Oncology and Hematology Care- Eastside

Portland, Oregon, 97213

Site Contact

Rom Leidner, Site 0001

[email protected]

503-215-5696

Local Institution - 0063, Nashville, Tennessee

Status

Not yet recruiting

Address

Local Institution - 0063

Nashville, Tennessee, 37067

Site Contact

Site 0063

[email protected]

855-907-3286

Local Institution - 0052, Nashville, Tennessee

Status

Not yet recruiting

Address

Local Institution - 0052

Nashville, Tennessee, 37232

Site Contact

Site 0052

[email protected]

855-907-3286

Local Institution - 0061, Houston, Texas

Status

Not yet recruiting

Address

Local Institution - 0061

Houston, Texas, 77030

Site Contact

Site 0061

[email protected]

855-907-3286

International Sites

Blacktown Hospital, Blacktown, New South Wales, Australia

Status

Recruiting

Address

Blacktown Hospital

Blacktown, New South Wales, 2148

Site Contact

Adnan Nagrial, Site 0057

[email protected]

61403170371

Liverpool Hospital, Liverpool, New South Wales, Australia

Status

Recruiting

Address

Liverpool Hospital

Liverpool, New South Wales, 2170

Site Contact

Abhijit Pal, Site 0058

[email protected]

61287389744

Princess Alexandra Hospital, Brisbane, Queensland, Australia

Status

Recruiting

Address

Princess Alexandra Hospital

Brisbane, Queensland, 4102

Site Contact

Aaron Hansen, Site 0054

[email protected]

61731765564

Cabrini Hospital - Malvern, Malvern, Victoria, Australia

Status

Recruiting

Address

Cabrini Hospital - Malvern

Malvern, Victoria, 3144

Site Contact

Shehara Mendis, Site 0053

[email protected]

(03) 9508 3434

St Vincent's Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

St Vincent's Hospital

Melbourne, Victoria, 3065

Site Contact

Melissa Moore, Site 0055

[email protected]

61392313155

One Clinical Research, Nedlands, Western Australia, Australia

Status

Recruiting

Address

One Clinical Research

Nedlands, Western Australia, 6009

Site Contact

Muhammad Khattak, Site 0056

[email protected]

0410565868

Cross Cancer Institute, Edmonton, Alberta, Canada

Status

Recruiting

Address

Cross Cancer Institute

Edmonton, Alberta, T6X 1E8

Site Contact

Quincy Chu, Site 0027

[email protected]

7804328248

BC Cancer Vancouver, Vancouver, British Columbia, Canada

Status

Recruiting

Address

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6

Site Contact

Anna Tinker, Site 0030

[email protected]

604-877-6000

Hamilton, Ontario, Canada

Status

Recruiting

Address

Hamilton Health Sciences-Juravinski Cancer Centre

Hamilton, Ontario, L8V5C2

Site Contact

Sebastien Hotte, Site 0029

[email protected]

9053170886

Local Institution - 0009, Toronto, Ontario, Canada

Status

Active, not recruiting

Address

Local Institution - 0009

Toronto, Ontario, M5G 2M9

Montreal, Quebec, Canada

Status

Recruiting

Address

Centre Hospitalier de luniversite de Montreal

Montreal, Quebec, H2X 0A9

Site Contact

Rahima Jamal, Site 0015

[email protected]

51489080008444

The Ottawa Hospital Cancer Centre, Ottawa, Canada

Status

Recruiting

Address

The Ottawa Hospital Cancer Centre

Ottawa, , K1H 8L6

Site Contact

John Hilton, Site 0016

[email protected]

(613)737-7700

Dresden, Germany

Status

Recruiting

Address

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

Dresden, , 01307

Site Contact

Martin Wermke, Site 0010

[email protected]

+493514587566

Universitaetsklinikum Essen, Essen, Germany

Status

Recruiting

Address

Universitaetsklinikum Essen

Essen, , 45147

Site Contact

Stefan Kasper-Virchow, Site 0018

[email protected]

0049201 7233449

Universitatsklinikum Frankfurt, Frankfurt, Germany

Status

Recruiting

Address

Universitatsklinikum Frankfurt

Frankfurt, , 60590

Site Contact

Martin Sebastian, Site 0020

[email protected]

+496963016217

Universitaetsklinikum Ulm, Ulm, Germany

Status

Recruiting

Address

Universitaetsklinikum Ulm

Ulm, , 89081

Site Contact

Simon Laban, Site 0044

[email protected]

4973150059548

Universitaetsklinikum Wuerzburg, Wuerzburg, Germany

Status

Recruiting

Address

Universitaetsklinikum Wuerzburg

Wuerzburg, , 97078

Site Contact

Cyrus Sayehli, Site 0019

[email protected]

4993120140964

Rabin Medical Center, Petah Tikva, HaMerkaz, Israel

Status

Recruiting

Address

Rabin Medical Center

Petah Tikva, HaMerkaz, 4941492

Site Contact

Salomon Stemmer, Site 0036

[email protected]

97239378076

Local Institution - 0035, Ramat Gan, HaMerkaz, Israel

Status

Withdrawn

Address

Local Institution - 0035

Ramat Gan, HaMerkaz, 5265601

Sheba Medical Center, Ramat Gan, HaMerkaz, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, HaMerkaz, 5265601

Site Contact

Tamar Beller, Site 0038

[email protected]

97235307039

Rambam Health Care Campus, Haifa, HaTsafon, Israel

Status

Recruiting

Address

Rambam Health Care Campus

Haifa, HaTsafon, 3109601

Site Contact

Ruth Perets, Site 0039

[email protected]

+972-47776700

Sourasky Medical Center, Tel Aviv, Tell Abīb, Israel

Status

Recruiting

Address

Sourasky Medical Center

Tel Aviv, Tell Abīb, 6423906

Site Contact

Ravit Geva, Site 0037

[email protected]

97236973082

Humanitas, Rozzano, Milano, Italy

Status

Recruiting

Address

Humanitas

Rozzano, Milano, 20089

Site Contact

Matteo Simonelli, Site 0023

[email protected]

+390282244559

Istituto di Candiolo, Candiolo, Torino, Italy

Status

Recruiting

Address

Istituto di Candiolo

Candiolo, Torino, 10060

Site Contact

Vanesa Gregorc, Site 0033

[email protected]

390119933250

Milan, Italy

Status

Recruiting

Address

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

Milan, , 20133

Site Contact

Filippo De Braud, Site 0024

[email protected]

390223903066

Napoli, Italy

Status

Recruiting

Address

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli, , 80131

Site Contact

Paolo Ascierto, Site 0034

[email protected]

390815903431

Roma, Italy

Status

Recruiting

Address

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

Roma, , 00168

Site Contact

Gennaro Daniele, Site 0040

[email protected]

+390630153446

Siena, Italy

Status

Recruiting

Address

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

Siena, , 53100

Site Contact

Michele Maio, Site 0025

[email protected]

390577586335

Local Institution - 0064, Kashiwa, Chiba, Japan

Status

Not yet recruiting

Address

Local Institution - 0064

Kashiwa, Chiba, 277-8577

Site Contact

Site 0064

[email protected]

855-907-3286

Málaga, Andalucía, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de la Victoria

Málaga, Andalucía, 29010

Site Contact

Javier Garcia Corbacho, Site 0048

[email protected]

951032250

Badalona, Barcelona [Barcelona], Spain

Status

Recruiting

Address

Institut Català d'Oncologia (ICO) - Badalona

Badalona, Barcelona [Barcelona], 08916

Site Contact

Cinta Hierro Carbo, Site 0014

[email protected]

34934978925

Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035

Site Contact

Elena Garralda Cabanas, Site 0049

[email protected]

349327460004910

Hospital Universitario 12 de Octubre, Madrid, Madrid, Comunidad De, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad De, 28041

Site Contact

Luis Paz-Ares Rodriguez, Site 0047

[email protected]

0034913908922

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD

Madrid, , 28040

Site Contact

Victor Moreno Garcia, Site 0013

[email protected]

615387743

Madrid, Spain

Status

Recruiting

Address

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

Madrid, , 28050

Site Contact

Emiliano Calvo Aller, Site 0011

[email protected]

+34620423957

Clinica Universidad de Navarra-oNCOLOGY, Pamplona, Spain

Status

Recruiting

Address

Clinica Universidad de Navarra-oNCOLOGY

Pamplona, , 31008

Site Contact

Ignacio Melero Bermejo, Site 0012

[email protected]

34653574014

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