Melanoma
Conditions
Brief summary
The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine \[DTIC\]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.
Interventions
DRUGMDX-010 (CTLA-4)
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of unresectable metastatic melanoma. * No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within 5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy) for melanoma.
Exclusion criteria
Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study: * Any other prior malignancy, except for the following: adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for \>=5 years. * Active autoimmune disease. * Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.
Countries
United States
Outcome results
None listed