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 46 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
Ryan Moy, Site 0006
Contact
714-726-7966
Memorial Sloan Kettering Nassau
New York New York, 10065, United States
Providence Cancer Center Oncology and Hematology Care- Eastside
Portland Oregon, 97213, United States More Info
Rom Leidner, Site 0001
Contact
503-215-5696
Local Institution - 0063
Nashville Tennessee, 37067, United States More Info
Site 0063
Contact
Local Institution - 0052
Nashville Tennessee, 37232, United States More Info
Site 0052
Contact
Local Institution - 0061
Houston Texas, 77030, United States More Info
Site 0061
Contact
Blacktown Hospital
Blacktown New South Wales, 2148, Australia More Info
Adnan Nagrial, Site 0057
Contact
61403170371
Liverpool Hospital
Liverpool New South Wales, 2170, Australia More Info
Abhijit Pal, Site 0058
Contact
61287389744
Princess Alexandra Hospital
Brisbane Queensland, 4102, Australia More Info
Aaron Hansen, Site 0054
Contact
61731765564
Cabrini Hospital - Malvern
Malvern Victoria, 3144, Australia More Info
Shehara Mendis, Site 0053
Contact
(03) 9508 3434
St Vincent's Hospital
Melbourne Victoria, 3065, Australia More Info
Melissa Moore, Site 0055
Contact
61392313155
One Clinical Research
Nedlands Western Australia, 6009, Australia More Info
Muhammad Khattak, Site 0056
Contact
0410565868
Cross Cancer Institute
Edmonton Alberta, T6X 1, Canada More Info
Quincy Chu, Site 0027
Contact
7804328248
BC Cancer Vancouver
Vancouver British Columbia, V5Z 4, Canada More Info
Anna Tinker, Site 0030
Contact
604-877-6000
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton Ontario, L8V5C, Canada More Info
Sebastien Hotte, Site 0029
Contact
9053170886
Local Institution - 0009
Toronto Ontario, M5G 2, Canada
Centre Hospitalier de luniversite de Montreal
Montreal Quebec, H2X 0, Canada More Info
Rahima Jamal, Site 0015
Contact
51489080008444
The Ottawa Hospital Cancer Centre
Ottawa , K1H 8, Canada More Info
John Hilton, Site 0016
Contact
(613)737-7700
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
Rabin Medical Center
Petah Tikva HaMerkaz, 49414, Israel More Info
Salomon Stemmer, Site 0036
Contact
97239378076
Local Institution - 0035
Ramat Gan HaMerkaz, 52656, Israel
Sheba Medical Center
Ramat Gan HaMerkaz, 52656, Israel More Info
Tamar Beller, Site 0038
Contact
97235307039
Rambam Health Care Campus
Haifa HaTsafon, 31096, Israel More Info
Ruth Perets, Site 0039
Contact
+972-47776700
Sourasky Medical Center
Tel Aviv Tell Abīb, 64239, Israel More Info
Ravit Geva, Site 0037
Contact
97236973082
Humanitas
Rozzano Milano, 20089, Italy More Info
Matteo Simonelli, Site 0023
Contact
+390282244559
Istituto di Candiolo
Candiolo Torino, 10060, Italy More Info
Vanesa Gregorc, Site 0033
Contact
390119933250
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
Milan , 20133, Italy More Info
Filippo De Braud, Site 0024
Contact
390223903066
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli , 80131, Italy More Info
Paolo Ascierto, Site 0034
Contact
390815903431
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma , 00168, Italy More Info
Gennaro Daniele, Site 0040
Contact
+390630153446
ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena , 53100, Italy More Info
Michele Maio, Site 0025
Contact
390577586335
Local Institution - 0064
Kashiwa Chiba, 277-8, Japan More Info
Site 0064
Contact
Hospital Universitario Virgen de la Victoria
Málaga Andalucía, 29010, Spain More Info
Javier Garcia Corbacho, Site 0048
Contact
951032250
Institut Català d'Oncologia (ICO) - Badalona
Badalona Barcelona [Barcelona], 08916, Spain More Info
Cinta Hierro Carbo, Site 0014
Contact
34934978925
Hospital Universitari Vall d'Hebron
Barcelona Barcelona [Barcelona], 08035, Spain More Info
Elena Garralda Cabanas, Site 0049
Contact
349327460004910
Hospital Universitario 12 de Octubre
Madrid Madrid, Comunidad De, 28041, Spain More Info
Luis Paz-Ares Rodriguez, Site 0047
Contact
0034913908922
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD
Madrid , 28040, Spain More Info
Victor Moreno Garcia, Site 0013
Contact
615387743
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC
Madrid , 28050, Spain More Info
Emiliano Calvo Aller, Site 0011
Contact
+34620423957
Clinica Universidad de Navarra-oNCOLOGY
Pamplona , 31008, Spain More Info
Ignacio Melero Bermejo, Site 0012
Contact
34653574014

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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