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Clinical Trial Finder

Search Results

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, China, 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 5338122, California 5332921

Status

Recruiting

Address

Community Cancer Institute

Clovis 5338122, California 5332921, 93611

Site Contact

Uzair Chaudhary, Site 0032

[email protected]

559-387-1600

USC/Norris Comprehensive Cancer Center, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

USC/Norris Comprehensive Cancer Center

Los Angeles 5368361, California 5332921, 90033

Site Contact

Anthony El-Khoueiry, Site 0041

[email protected]

323-865-3967

Hoag Memorial Hospital Presbyterian, Newport Beach 5376890, California 5332921

Status

Recruiting

Address

Hoag Memorial Hospital Presbyterian

Newport Beach 5376890, California 5332921, 92663

Site Contact

Carlos Becerra, Site 0050

[email protected]

949-764-8222

University of Iowa, Iowa City 4862034, Iowa 4862182

Status

Recruiting

Address

University of Iowa

Iowa City 4862034, Iowa 4862182, 52242

Site Contact

Douglas Laux, Site 0062

[email protected]

319-356-1032

John Theurer Cancer Center, Hackensack 5098706, New Jersey 5101760

Status

Recruiting

Address

John Theurer Cancer Center

Hackensack 5098706, New Jersey 5101760, 07601

Site Contact

Martin Gutierrez, Site 0007

[email protected]

551-996-5863

Local Institution - 0006, New York 5128581, New York 5128638

Status

Active, not recruiting

Address

Local Institution - 0006

New York 5128581, New York 5128638, 10032

Site Contact

[email protected]

855-907-3286

Local Institution - 0002, New York 5128581, New York 5128638

Status

Completed

Address

Local Institution - 0002

New York 5128581, New York 5128638, 10065

Site Contact

[email protected]

855-907-3286

Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Providence Cancer Center Oncology and Hematology Care- Eastside

Portland 5746545, Oregon 5744337, 97213

Site Contact

Rom Leidner, Site 0001

[email protected]

503-215-5696

Local Institution - 0063, Nashville 4644585, Tennessee 4662168

Status

Not yet recruiting

Address

Local Institution - 0063

Nashville 4644585, Tennessee 4662168, 37067

Site Contact

Site 0063

[email protected]

855-907-3286

Vanderbilt University Medical Center, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville 4644585, Tennessee 4662168, 37232

Site Contact

Jordan Berlin, Site 0052

[email protected]

615-343-4967

Houston Methodist Hospital, Houston 4699066, Texas 4736286

Status

Recruiting

Address

Houston Methodist Hospital

Houston 4699066, Texas 4736286, 77030

Site Contact

Maen Abdelrahim, Site 0061

[email protected]

346-241-5495

International Sites

Blacktown Hospital, Blacktown 2175411, New South Wales 2155400, Australia

Status

Recruiting

Address

Blacktown Hospital

Blacktown 2175411, New South Wales 2155400, 2148

Site Contact

Adnan Nagrial, Site 0057

[email protected]

+61 02 86705071

Liverpool Hospital, Liverpool 2159851, New South Wales 2155400, Australia

Status

Recruiting

Address

Liverpool Hospital

Liverpool 2159851, New South Wales 2155400, 2170

Site Contact

Abhijit Pal, Site 0058

[email protected]

61287389744

Princess Alexandra Hospital, Brisbane 2174003, Queensland 2152274, Australia

Status

Recruiting

Address

Princess Alexandra Hospital

Brisbane 2174003, Queensland 2152274, 4102

Site Contact

Aaron Hansen, Site 0054

[email protected]

61731765564

Cabrini Hospital - Malvern, Malvern 2158952, Victoria 2145234, Australia

Status

Recruiting

Address

Cabrini Hospital - Malvern

Malvern 2158952, Victoria 2145234, 3144

Site Contact

Shehara Mendis, Site 0053

[email protected]

(03)95083434

St Vincent's Hospital, Melbourne 2158177, Victoria 2145234, Australia

Status

Recruiting

Address

St Vincent's Hospital

Melbourne 2158177, Victoria 2145234, 3065

Site Contact

Melissa Moore, Site 0055

[email protected]

61392313155

One Clinical Research, Nedlands 2064874, Western Australia 2058645, Australia

Status

Recruiting

Address

One Clinical Research

Nedlands 2064874, Western Australia 2058645, 6009

Site Contact

Muhammad Khattak, Site 0056

[email protected]

+61 08 6279 9466

Cross Cancer Institute, Edmonton 5946768, Alberta 5883102, Canada

Status

Recruiting

Address

Cross Cancer Institute

Edmonton 5946768, Alberta 5883102, T6X 1E8

Site Contact

Quincy Chu, Site 0027

[email protected]

7804328248

BC Cancer Vancouver, Vancouver 6173331, British Columbia 5909050, Canada

Status

Recruiting

Address

BC Cancer Vancouver

Vancouver 6173331, British Columbia 5909050, V5Z 4E6

Site Contact

Anna Tinker, Site 0030

[email protected]

604-877-6000

Hamilton 5969782, Ontario 6093943, Canada

Status

Recruiting

Address

Hamilton Health Sciences-Juravinski Cancer Centre

Hamilton 5969782, Ontario 6093943, L8V5C2

Site Contact

Sebastien Hotte, Site 0029

[email protected]

9053170886

Local Institution - 0009, Toronto 6167865, Ontario 6093943, Canada

Status

Completed

Address

Local Institution - 0009

Toronto 6167865, Ontario 6093943, M5G 2M9

Site Contact

[email protected]

855-907-3286

Montreal 6077243, Quebec 6115047, Canada

Status

Recruiting

Address

Centre Hospitalier de luniversite de Montreal

Montreal 6077243, Quebec 6115047, H2X 0A9

Site Contact

Rahima Jamal, Site 0015

[email protected]

51489080008444

The Ottawa Hospital Cancer Centre, Ottawa 6094817, Canada

Status

Recruiting

Address

The Ottawa Hospital Cancer Centre

Ottawa 6094817, , K1H 8L6

Site Contact

John Hilton, Site 0016

[email protected]

(613)737-7700

Local Institution - 0067, Beijing 1816670, Beijing Municipality 2038349, China

Status

Not yet recruiting

Address

Local Institution - 0067

Beijing 1816670, Beijing Municipality 2038349, 100142

Site Contact

Site 0067

[email protected]

855-907-3286

Local Institution - 0066, Jinan 1805753, Shandong 1796328, China

Status

Not yet recruiting

Address

Local Institution - 0066

Jinan 1805753, Shandong 1796328, 250117

Site Contact

Site 0066

[email protected]

855-907-3286

Local Institution - 0065, Hangzhou 1808926, Zhejiang 1784764, China

Status

Not yet recruiting

Address

Local Institution - 0065

Hangzhou 1808926, Zhejiang 1784764, 310022

Site Contact

Site 0065

[email protected]

855-907-3286

Universitaetsklinikum Ulm, Ulm 2820256, Baden-Wurttemberg 2953481, Germany

Status

Recruiting

Address

Universitaetsklinikum Ulm

Ulm 2820256, Baden-Wurttemberg 2953481, 89081

Site Contact

Simon Laban, Site 0044

[email protected]

4973150059548

Dresden 2935022, Germany

Status

Recruiting

Address

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

Dresden 2935022, , 01307

Site Contact

Martin Wermke, Site 0010

[email protected]

+493514587566

Universitaetsklinikum Essen, Essen 2928810, Germany

Status

Recruiting

Address

Universitaetsklinikum Essen

Essen 2928810, , 45147

Site Contact

Stefan Kasper-Virchow, Site 0018

[email protected]

00492017233449

Universitatsklinikum Frankfurt, Frankfurt 2925536, Germany

Status

Recruiting

Address

Universitatsklinikum Frankfurt

Frankfurt 2925536, , 60590

Site Contact

Martin Sebastian, Site 0020

[email protected]

+496963016217

Universitaetsklinikum Wuerzburg, Würzburg 2805615, Germany

Status

Recruiting

Address

Universitaetsklinikum Wuerzburg

Würzburg 2805615, , 97078

Site Contact

Cyrus Sayehli, Site 0019

[email protected]

4993120140964

Rabin Medical Center, Petah Tikva 293918, Central District 294904, Israel

Status

Recruiting

Address

Rabin Medical Center

Petah Tikva 293918, Central District 294904, 4941492

Site Contact

Salomon Stemmer, Site 0036

[email protected]

97239378076

Local Institution - 0035, Ramat Gan, Central District 294904, Israel

Status

Withdrawn

Address

Local Institution - 0035

Ramat Gan, Central District 294904, 5265601

Site Contact

[email protected]

855-907-3286

Sheba Medical Center, Ramat Gan, Central District 294904, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, Central District 294904, 5265601

Site Contact

Tamar Beller, Site 0038

[email protected]

97235302542

Rambam Health Care Campus, Haifa, Northern District 294824, Israel

Status

Recruiting

Address

Rambam Health Care Campus

Haifa, Northern District 294824, 3109601

Site Contact

Ruth Perets, Site 0039

[email protected]

+972-47776700

Sourasky Medical Center, Tel Aviv 293397, Tell Abīb, Israel

Status

Recruiting

Address

Sourasky Medical Center

Tel Aviv 293397, Tell Abīb, 6423906

Site Contact

Ravit Geva, Site 0037

[email protected]

97236973082

Humanitas, Rozzano 3168837, Milano, Italy

Status

Recruiting

Address

Humanitas

Rozzano 3168837, Milano, 20089

Site Contact

Matteo Simonelli, Site 0023

[email protected]

+390282244559

Candiolo 3180861, Torino, Italy

Status

Recruiting

Address

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

Candiolo 3180861, Torino, 10060

Site Contact

Vanesa Gregorc, Site 0033

[email protected]

390119933250

Milan 3173435, Italy

Status

Recruiting

Address

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

Milan 3173435, , 20133

Site Contact

Filippo De Braud, Site 0024

[email protected]

390223903066

Napoli 9031661, Italy

Status

Recruiting

Address

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli 9031661, , 80131

Site Contact

Paolo Ascierto, Site 0034

[email protected]

390815903431

Roma 8957247, Italy

Status

Recruiting

Address

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

Roma 8957247, , 00168

Site Contact

Gennaro Daniele, Site 0040

[email protected]

+390630153446

Siena 3166548, Italy

Status

Recruiting

Address

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

Siena 3166548, , 53100

Site Contact

Michele Maio, Site 0025

[email protected]

390577586335

National Cancer Center Hospital East, Kashiwa 1859924, Chiba 2113014, Japan

Status

Recruiting

Address

National Cancer Center Hospital East

Kashiwa 1859924, Chiba 2113014, 277-8577

Site Contact

Yasutoshi Kuboki, Site 0064

[email protected]

81471331111

Málaga 2514256, Andalusia 2593109, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de la Victoria

Málaga 2514256, Andalusia 2593109, 29010

Site Contact

Javier Garcia Corbacho, Site 0048

[email protected]

951032250

Badalona 3129028, Barcelona [Barcelona], Spain

Status

Recruiting

Address

Institut Catalan d Oncologia (ICO) - Badalona

Badalona 3129028, Barcelona [Barcelona], 08916

Site Contact

Cinta Hierro Carbo, Site 0014

[email protected]

34934978925

Hospital Universitari Vall d'Hebron, Barcelona 3128760, Barcelona [Barcelona], Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona 3128760, Barcelona [Barcelona], 08035

Site Contact

Elena Garralda Cabanas, Site 0049

[email protected]

349327460004910

Hospital Universitario 12 de Octubre, Madrid 3117735, Madrid, Comunidad de, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid 3117735, Madrid, Comunidad de, 28041

Site Contact

Luis Paz-Ares Rodriguez, Site 0047

[email protected]

0034913908922

Madrid 3117735, Spain

Status

Recruiting

Address

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD

Madrid 3117735, , 28040

Site Contact

Victor Moreno Garcia, Site 0013

[email protected]

915504800ext2805

Madrid 3117735, Spain

Status

Recruiting

Address

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

Madrid 3117735, , 28050

Site Contact

Emiliano Calvo, Site 0011

[email protected]

+34934894304

Clinica Universidad de Navarra-oNCOLOGY, Pamplona 3114472, Spain

Status

Recruiting

Address

Clinica Universidad de Navarra-oNCOLOGY

Pamplona 3114472, , 31008

Site Contact

Ignacio Melero Bermejo, Site 0012

[email protected]

34948255400

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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