NCT04099251Active, not recruitingPhase 3
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 790 (actual)
- First submitted
- 20 Sept 2019
- Start date
- 28 Oct 2019
- Primary completion date
- 28 Jun 2022
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Melanoma, Childhood cancers
- NCT number
- NCT04099251
- EudraCT number
- 2022-502354-14
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 790
- From 28 Oct 2019 to the primary completion date, 28 Jun 2022
- 130 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of ocular or mucosal melanoma.
- Participants with active known or suspected autoimmune disease.
- Known history of allergy or hypersensitivity to study drug components.
Other
- Pregnant or nursing women.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (130)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0049 Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Local Institution - 0051 Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Local Institution - 0105 Coordinator of this site? Confirm its status | Cairns | Australia | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Geelong | Australia | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Greenslopes | Australia | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Malvern | Australia | Unknown status |
| Local Institution - 0106 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Local Institution - 0138 Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Wollstonecraft | Australia | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Local Institution - 0142 Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0123 Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Local Institution - 0133 Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Local Institution - 0053 Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Ostrava-Poruba | Czechia | Unknown status |
| Local Institution - 0073 Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Local Institution - 0074 Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Local Institution - 0072 Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Buxtehude | Germany | Unknown status |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Gera | Germany | Unknown status |
| Local Institution - 0114 Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| Local Institution - 0060 Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Local Institution - 0055 Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Local Institution - 0057 Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Local Institution - 0056 Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Local Institution - 0102 Coordinator of this site? Confirm its status | Regensburg | Germany | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Local Institution - 0067 Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Local Institution - 0065 Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Local Institution - 0071 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0066 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0068 Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Local Institution - 0064 Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Local Institution - 0014 Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Tampere | Finland | Unknown status |
| Local Institution - 0110 Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Local Institution - 0112 Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Local Institution - 0113 Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Local Institution - 0111 Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Local Institution - 0082 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Local Institution - 0084 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Local Institution - 0083 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Local Institution - 0146 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Local Institution - 0101 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Local Institution - 0039 Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Local Institution - 0046 Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Local Institution - 0145 Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Local Institution - 0038 Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Local Institution - 0107 Coordinator of this site? Confirm its status | Breda | Netherlands | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Grålum | Norway | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Local Institution - 0023 Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Local Institution - 0022 Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Craiova | Romania | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Sector 2 | Romania | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Linköping | Sweden | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | Örebro | Sweden | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Local Institution - 0141 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Local Institution - 0144 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Local Institution - 0088 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0143 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0086 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Local Institution - 0132 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Local Institution - 0099 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0085 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0090 Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Local Institution - 0148 Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Local Institution - 0080 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0151 Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Local Institution - 0094 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Local Institution - 0081 Coordinator of this site? Confirm its status | Robbinsdale | United States | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Local Institution - 0119 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Local Institution - 0122 Coordinator of this site? Confirm its status | San Jose | United States | Unknown status |
| Local Institution - 0087 Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| Local Institution - 0126 Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Local Institution - 0109 Coordinator of this site? Confirm its status | Vallejo | United States | Unknown status |
| Local Institution - 0121 Coordinator of this site? Confirm its status | Vallejo | United States | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Vallejo | United States | Unknown status |
| Local Institution - 0089 Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.