Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (CheckMate 238)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Melanoma

Treatments: Drug: Ipilimumab; Drug: Nivolumab; Other: Placebo matching Ipilimumab; Other: Placebo matching Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388906

CA209-238

2014-002351-26 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

Enrollment: 906 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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906 participants in 2 patient groups

Ipilimumab and Placebo matching Nivolumab

Experimental group

Treatment:

Other: Placebo matching Nivolumab

Drug: Ipilimumab

Nivolumab and Placebo matching Ipilimumab

Experimental group

Treatment:

Other: Placebo matching Ipilimumab

Drug: Nivolumab