CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 790 enrolled / 790 target
Drug / intervention
Nivolumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04099251
NCT04099251Phase 3ActiveUpdate Overdue (9.9/mo)Completion was 48mo ago
CompareCT.gov

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

Bristol-Myers Squibb·interventional·Posted Sep 23, 2019·Updated Jun 23, 2026

In Brief

A Phase 3 clinical trial evaluating Nivolumab and Placebo for Melanoma. Active but no longer recruiting, targeting 790 participants across 130 sites in 20 countries.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
20202021202220232024202520262027
First PostedSep 23, 2019
Enrollment StartOct 28, 2019
Primary CompletionJun 28, 2022
Study CompletionNov 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.8 years ago

Arms & Interventions

Nivolumabexperimental

Biological: Nivolumab
Placeboplacebo_comparator

Other: Placebo

Interventions

Nivolumabbiological

Specified dose on specified days

Placeboother

Specified dose on specified days