Melanoma Clinical Trial

A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors

Summary

The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 (BMS-986415) alone and in combination with Nivolumab in participants with advanced solid tumors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate
ECOG performance status of 0 or 1
Clinical or radiological evidence of disease
Adequate hematological, hepatic and renal function
Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessed by Investigator as being at high risk for venous thromboembolism (VTE) or history of VTE ≥ 6 months from enrollment

Exclusion Criteria:

Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment
Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ
Rapidly progressive disease
Serious cardiac illness or medical conditions
Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

473

Study ID:

NCT04423029

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 36 Locations for this study

See Locations Near You

Local Institution
Orange California, 92868, United States
University of California Irvine
Orange California, 92868, United States More Info
Jennifer Valerin, Site 0014
Contact
714-456-5153
SCRI - HealthOne Denver
Denver Colorado, 80218, United States
Local Institution
New Haven Connecticut, 06520, United States
Yale School of Medicine
New Haven Connecticut, 06520, United States More Info
Mario Sznol, Site 0017
Contact
203-464-8725
Local Institution
Miami Florida, 33136, United States
University of Miami
Miami Florida, 33136, United States More Info
Jose Lutzky, Site 0003
Contact
786-208-8076
Augusta University Georgia Cancer Center
Augusta Georgia, 30912, United States More Info
Sharad Ghamande, Site 0033
Contact
706-721-3992
Local Institution
Augusta Georgia, 30912, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States More Info
Mohammed Milhem, Site 0011
Contact
319-356-2324
Local Institution
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Dipesh Uprety, Site 0020
Contact
31357687463135769810
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Ding Wang, Site 0013
Contact
73447980147344793311
Local Institution
Detroit Michigan, 48202, United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul Minnesota, 55101, United States More Info
Arkadiusz Dudek, Site 0005
Contact
31299615816512543321
Local Institution
Saint Paul Minnesota, 55101, United States
Atlantic Health System
Morristown New Jersey, 07960, United States More Info
Eric Whitman, Site 0004
Contact
973-971-7111
Local Institution
Bronx New York, 10461, United States
Montefiore Medical Center
Bronx New York, 10467, United States More Info
Jinyu Lu, Site 0021
Contact
718-405-8404
Local Institution
Buffalo New York, 14203, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States More Info
Christos Fountzilas, Site 0008
Contact
Local Institution
Cleveland Ohio, 44106, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Jorge Garcia, Site 0032
Contact
216-312-4225
Local Institution
Oklahoma City Oklahoma, 73104, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Raid Aljumaily, Site 0007
Contact
405-271-4022
Local Institution
Providence Rhode Island, 02903, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States More Info
Benedito Carneiro Filho, Site 0006
Contact
401-606-5483
Lifespan - The Miriam Hospital
Providence Rhode Island, 02906, United States More Info
Benedito Carneiro Filho, Site 0034
Contact
401-606-5483
Local Institution
Nashville Tennessee, 37205, United States
SCRI - Tennessee Oncology - Saint Thomas West Clinic
Nashville Tennessee, 37205, United States More Info
Meredith McKean, Site 0012
Contact
615-329-7274
Local Institution
Houston Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Hussein Tawbi, Site 0016
Contact
713-792-4185
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Sangeeta Goswami, Site 0009
Contact
832-292-4157
Huntsman Cancer Institute and Hospital
Salt Lake City Utah, 84112, United States More Info
Siwen Hu-Lieskovan, Site 0019
Contact
801-585-0255
Local Institution
Salt Lake City Utah, 84112, United States
Local Institution
Fairfax Virginia, 22031, United States
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax Virginia, 22031, United States More Info
Alexander Spira, Site 0015
Contact
703-280-5390
Froedtert Hospital
Milwaukee Wisconsin, 53226, United States More Info
Ariel Nelson, Site 0024
Contact
41480549234148054600
Local Institution - 0023
Box Hill , 3128, Australia
Local Institution - 0022
Heidelberg , 3084, Australia
Local Institution
Paris Ile-de-France, 75010, France
Local Institution
Pierre-Bénite Rhone, 69495, France
Local Institution - 0026
Bordeaux Cedex , 33000, France More Info
Site 0026
Contact
Local Institution - 0002
Paris , 75010, France More Info
Site 0002
Contact
Local Institution - 0027
Pierre-Benite , 69495, France More Info
Site 0027
Contact
Local Institution - 0001
Villejuif , 94805, France More Info
Site 0001
Contact
Local Institution
Pamplona Navarre, 31008, Spain
Local Institution - 0029
Barcelona , 08035, Spain More Info
Site 0029
Contact
Local Institution
Madrid , 08040, Spain
Local Institution - 0031
Madrid , 28027, Spain More Info
Site 0031
Contact
Local Institution - 0030
Madrid , 28034, Spain More Info
Site 0030
Contact
Local Institution
Madrid , 28034, Spain
Local Institution - 0028
Madrid , 28040, Spain More Info
Site 0028
Contact
Local Institution - 0025
Pamplona , 31008, Spain More Info
Site 0025
Contact

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

473

Study ID:

NCT04423029

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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