Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Melanoma

Treatments

Drug: MDX-010 (CTLA-4)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00050102

MDX010-08

CA184-013 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.