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MDX-010 Alone or with gp100 Peptides in Stage IV Melanoma
NCT00077532Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2004
- Primary completion
- Jan 2007
- Countries
- 1
- Sponsor
- National Institutes of Health
- Modality
- Monoclonal Antibodies
- Drugs
- ipilimumab
- Conditions
- melanoma
01
Overview
Phase 2, randomised, open-label trial of ipilimumab in melanoma (2 arms), sponsored by National Institutes of Health. Primary endpoint: Objective Response (Partial and Complete). Started Mar 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
MDX-010 Alone
MDX-010 IV every 3 weeks
MDX-010 + gp100
MDX-010 IV + gp100 peptides emulsified in Montanide ISA-51 SC every 3 weeks
03
Who it enrols
Patients aged 16+ with histologically confirmed stage IV melanoma, ECOG 0-2, and adequate organ function. Excludes patients with active autoimmune disease, HIV, Hepatitis B/C, or prior anti-CTLA-4 therapy.
04
Endpoints
Primary
Objective Response (Partial and Complete)
Secondary
Safety and Toxicity Profile
Immunologic Response
Pharmacokinetics
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