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: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10040891Term: Skin melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003729-41-PL
• 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: 2017-04-11
• Study Completion: 2021-02-02
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1844

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? 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 1894
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