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.
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
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There are 36 Locations for this study
Orange California, 92868, United States
Denver Colorado, 80218, United States
New Haven Connecticut, 06520, United States
Miami Florida, 33136, United States
Augusta Georgia, 30912, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Saint Paul Minnesota, 55101, United States More Info
Saint Paul Minnesota, 55101, United States
Bronx New York, 10461, United States
Buffalo New York, 14203, United States
Buffalo New York, 14263, United States More Info
Contact
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73104, United States
Providence Rhode Island, 02903, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37205, United States More Info
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Fairfax Virginia, 22031, United States
Fairfax Virginia, 22031, United States More Info
Box Hill , 3128, Australia
Heidelberg , 3084, Australia
Paris Ile-de-France, 75010, France
Pierre-Bénite Rhone, 69495, France
Pamplona Navarre, 31008, Spain
Madrid , 08040, Spain
Madrid , 28034, Spain
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