A Study of Nivolumab in Combination with Ipilimumab Compared to Nivolumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.

Phase 1

• Conditions: Stage IIIb/c/d or Stage IV no evidence of disease (NED) melanoma following complete resection of the lesion(s) with high risk of relapse.; MedDRA version: 20.0 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10040891 Term: Skin melanoma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003729-41-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 2560

Inclusion Criteria

_Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study;
_Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work;
_No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions).
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 1884
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 666

Exclusion Criteria

_History of ocular/uveal melanoma;
_;
_Patients with active, known or suspected autoimmune disease;
_Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

Study & Design

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