Study comparing nivolumab to ipilimumab in prevention of recurrenceof melanoma after complete resection of stage IIIb/c or Stage IV melanoma

Phase 1

• Conditions: High risk, completely resected Stage IIIb/c and IV melanoma subjects; MedDRA version: 19.0Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002351-26-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-11
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1070

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? no
Number of subjects for this age range:
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified