Esophageal Cancer Clinical Trial

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

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 in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

View Eligibility Criteria

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 is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

665

Study ID:

NCT04895709

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 44 Locations for this study

See Locations Near You

Community Cancer Institute
Clovis California, 93611, United States More Info
Uzair Chaudhary, Site 0032
Contact
559-387-1600
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Anthony El-Khoueiry, Site 0041
Contact
323-865-3967
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States More Info
Carlos Becerra, Site 0050
Contact
949-764-8222
University of Iowa
Iowa City Iowa, 52242, United States More Info
Yousef Zakharia, Site 0062
Contact
319-384-8076
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States More Info
Martin Gutierrez, Site 0007
Contact
551-996-5863
Columbia University Irving Medical Center
New York New York, 10032, United States More Info
Shaheer Khan, Site 0006
Contact
646-942-4921
Memorial Sloan Kettering Nassau
New York New York, 10065, United States More Info
Margaret Callahan, Site 0002
Contact
186-049-0095
Providence Cancer Center Oncology and Hematology Care- Eastside
Portland Oregon, 97213, United States More Info
Rom Leidner, Site 0001
Contact
503-215-5696
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
Jordan Berlin, Site 0052
Contact
615-343-4967
Houston Methodist Hospital
Houston Texas, 77030, United States More Info
Maen Abdelrahim, Site 0061
Contact
346-241-5495
Local Institution - 0057
Blacktown New South Wales, 2148, Australia More Info
Site 0057
Contact
Local Institution - 0058
Liverpool New South Wales, 2170, Australia More Info
Site 0058
Contact
Local Institution - 0054
Brisbane Queensland, 4102, Australia More Info
Site 0054
Contact
Local Institution - 0053
Malvern Victoria, 3144, Australia More Info
Site 0053
Contact
Local Institution - 0055
Melbourne Victoria, 3065, Australia More Info
Site 0055
Contact
Local Institution - 0056
Nedlands Western Australia, 6009, Australia More Info
Site 0056
Contact
Local Institution - 0030
Vancouver British Columbia, V5Z 4, Canada More Info
Site 0030
Contact
Local Institution - 0029
Hamilton Ontario, L8V5C, Canada More Info
Site 0029
Contact
Local Institution - 0009
Toronto Ontario, M5G 2, Canada More Info
Site 0009
Contact
Local Institution - 0015
Montreal Quebec, H2X 0, Canada More Info
Site 0015
Contact
Local Institution - 0027
Edmonton , T6X 1, Canada More Info
Site 0027
Contact
Local Institution - 0016
Ottawa , K1H 8, Canada More Info
Site 0016
Contact
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
Dresden , 01307, Germany More Info
Martin Wermke, Site 0010
Contact
+493514587566
Universitaetsklinikum Essen
Essen , 45147, Germany More Info
Stefan Kasper-Virchow, Site 0018
Contact
0049201 7233449
Universitatsklinikum Frankfurt
Frankfurt , 60590, Germany More Info
Martin Sebastian, Site 0020
Contact
+496963016217
Universitaetsklinikum Ulm
Ulm , 89081, Germany More Info
Simon Laban, Site 0044
Contact
+4973150059548
Universitaetsklinikum Wuerzburg
Wuerzburg , 97078, Germany More Info
Cyrus Sayehli, Site 0019
Contact
4993120140964
Local Institution - 0036
Petah Tikva HaMerkaz, 49414, Israel More Info
Site 0036
Contact
Local Institution - 0035
Ramat Gan HaMerkaz, 52656, Israel
Local Institution - 0038
Ramat Gan HaMerkaz, 52656, Israel More Info
Site 0038
Contact
Local Institution - 0039
Haifa HaTsafon, 31096, Israel More Info
Site 0039
Contact
Local Institution - 0037
Tel Aviv Tell Abīb, 64239, Israel More Info
Site 0037
Contact
Humanitas
Rozzano Milano, 20089, Italy More Info
Matteo Simonelli, Site 0023
Contact
+390282244559
Local Institution - 0033
Candiolo Torino, 10060, Italy More Info
Site 0033
Contact
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
Milan , 20133, Italy More Info
Filippo De Braud, Site 0024
Contact
390223903066
Local Institution - 0034
Napoli , 80131, Italy More Info
Site 0034
Contact
Local Institution - 0040
Roma , 00168, Italy More Info
Site 0040
Contact
ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena , 53100, Italy More Info
Michele Maio, Site 0025
Contact
390577586335
Local Institution - 0048
Málaga Andalucía, 29010, Spain More Info
Site 0048
Contact
Local Institution - 0014
Badalona Barcelona [Barcelona], 08916, Spain More Info
Site 0014
Contact
Local Institution - 0049
Barcelona Barcelona [Barcelona], 08035, Spain More Info
Site 0049
Contact
Local Institution - 0047
Madrid Madrid, Comunidad De, 28041, Spain More Info
Site 0047
Contact
Local Institution - 0013
Madrid , 28040, Spain More Info
Site 0013
Contact
Local Institution - 0011
Madrid , 28050, Spain More Info
Site 0011
Contact
Local Institution - 0012
Pamplona , 31008, Spain More Info
Site 0012
Contact

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

665

Study ID:

NCT04895709

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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