EUCTR2014-002351-26-ESActive, not recruitingNot Applicable
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects who are at High Risk for RecurrencePharmacogenetics Blood Sample Amendment 01 (site-specific)- dated 03-dec-2014 - CheckMate 238: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 238)
Bristol-Myers Squibb International Corporation0 sites1,070 target enrollmentStarted: February 26, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,070
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Man and woman, 15 years or older (in some countries, only subjects aged 18 years or older will be recruited)
- •-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
- •-Adequate function of the blood, kidney, and liver
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 870
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
Exclusion Criteria
- •-Ocular or uveal melanoma
- •-History of carcinomatosis meningitis
- •-History of auto-immune disease
- •-Previous non-melanoma cancers unless complete remission since 3 years
- •-Treatment directed against the resected melanoma that is administrated after the surgery
- •-Postive testing for hepatitis B, hepatitis C, or known HIV
Investigators
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