Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

NCT04099251 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2019-10-28

Last updated

2026-08-07

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

NivolumabPlacebo

Nivolumab: Specified dose on specified days

Placebo: Specified dose on specified days

Study summary

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Had a negative sentinel lymph node biopsy. * Participant has not been previously treated for melanoma. * ECOG 0 or 1. * Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma. Exclusion Criteria: * History of ocular or mucosal melanoma. * Pregnant or nursing women. * Participants with active known or suspected autoimmune disease. * Known history of allergy or hypersensitivity to study drug components. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways. Other protocol defined inclusion/exclusion criteria apply.

Primary outcome measure(s)

Recurrence Free Survival (RFS) — From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)
Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization.

Trial sites (130)

Facility	City	Region
Local Institution - 0088	Birmingham	Alabama
Local Institution - 0126	Tucson	Arizona
Local Institution - 0087	Springdale	Arkansas
Local Institution - 0080	Los Angeles	California
Local Institution - 0077	San Francisco	California
Local Institution - 0119	San Francisco	California
Local Institution - 0122	San Jose	California
Local Institution - 0121	Vallejo	California
Local Institution - 0109	Vallejo	California
Local Institution - 0120	Vallejo	California
Local Institution - 0091	Aurora	Colorado
Local Institution - 0089	Washington D.C.	District of Columbia
Local Institution - 0141	Atlanta	Georgia
Local Institution - 0132	Chicago	Illinois
Local Institution - 0135	Baltimore	Maryland
Local Institution - 0078	Boston	Massachusetts
Local Institution - 0127	Boston	Massachusetts
Local Institution - 0143	Boston	Massachusetts
Local Institution - 0151	Minneapolis	Minnesota
Local Institution - 0081	Robbinsdale	Minnesota
Local Institution - 0079	Omaha	Nebraska
Local Institution - 0093	Hackensack	New Jersey
Local Institution - 0094	New York	New York
Local Institution - 0086	Charlotte	North Carolina
Local Institution - 0099	Cleveland	Ohio
Local Institution - 0076	Portland	Oregon
Local Institution - 0092	Allentown	Pennsylvania
Local Institution - 0031	Pittsburgh	Pennsylvania
Local Institution - 0148	Germantown	Tennessee
Local Institution - 0144	Austin	Texas
Local Institution - 0085	Dallas	Texas
Local Institution - 0090	Fairfax	Virginia
Local Institution - 0018	Waratah	New South Wales
Local Institution - 0025	Westmead	New South Wales
Local Institution - 0016	Wollstonecraft	New South Wales
Local Institution - 0105	Cairns	Queensland
Local Institution - 0017	Greenslopes	Queensland
Local Institution - 0024	Herston	Queensland
Local Institution - 0138	Southport	Queensland
Local Institution - 0019	Box Hill	Victoria

+ 90 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

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Other trials for the same condition

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. Recruiting

A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) Active, not recruiting

A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition Active, not recruiting

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04099251 on ClinicalTrials.gov ↗ ← All trials in the UK