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Clinical Trials in the Netherlands / NCT04099251
Active, not recruiting Phase 3

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 Netherlands 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)

Nivolumab →Placebo

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
No
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)

FacilityCityRegionStatus
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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A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1% Recruiting
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Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) Recruiting

Other trials for the same condition

Timing of Immunotherapy in Melanoma Recruiting
Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Active, not recruiting
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma Active, not recruiting
Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma Active, not recruiting
MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer Recruiting
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 Netherlands