Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
Purpose
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
Condition
- Melanoma
Eligibility
- Eligible Ages
- Over 15 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age - Completely removed melanoma by surgery performed within 12 weeks of randomization - Stage IIIb/C or Stage IV before complete resection - No previous anti-cancer treatment
Exclusion Criteria
- Ocular or uveal melanoma - History of carcinomatosis meningitis - History of auto-immune disease - Treatment directed against the resected melanoma that is administrated after the surgery Other protocol-defined inclusion/exclusion criteria apply
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ipilimumab and Placebo matching Nivolumab |
|
|
|
Experimental Nivolumab and Placebo matching Ipilimumab |
|
Recruiting Locations
More Details
- NCT ID
- NCT02388906
- Status
- Active, not recruiting
- Sponsor
- Bristol-Myers Squibb