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

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Ipilimumab

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.