Study on Nivolumab for Preventing Melanoma Recurrence in Patients with Completely Removed Stage IIB/C Melanoma

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What is this study about?

This clinical trial is focused on studying a type of skin cancer called Stage IIB/C melanoma. The study is investigating the effectiveness of a treatment called nivolumab, which is also known by its code name BMS-936558. Nivolumab is a type of medication that is given through an infusion, which means it is delivered directly into the bloodstream through a vein. The trial compares nivolumab to a placebo to see if it can help prevent the cancer from coming back after it has been completely removed by surgery.

The main goal of the study is to see how well nivolumab works in keeping the cancer from returning. Participants in the study will receive either nivolumab or a placebo after their melanoma has been surgically removed. The study will monitor participants over a period of time to check for any signs of the cancer returning. This will help researchers understand if nivolumab can provide better outcomes compared to not receiving the active treatment.

Throughout the study, participants will undergo regular check-ups and imaging tests, such as CT scans and MRI, to ensure there is no evidence of the disease. The study aims to provide valuable information on whether nivolumab can be an effective treatment option for preventing the recurrence of Stage IIB/C melanoma after surgery. The trial is expected to continue until 2027, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatment.

1 randomization

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication nivolumab, and the other group will receive a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

2 treatment administration

If you are in the group receiving nivolumab, you will be given a solution called OPDIVO at a concentration of 10 mg/mL. This will be administered through an intravenous infusion, which means it will be given directly into your vein.

The frequency and duration of the administration will be determined by the study protocol, and you will be informed about the specific schedule.

3 monitoring and follow-up

Throughout the trial, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to ensure your safety and to assess the effectiveness of the treatment.

You will be required to attend scheduled visits to the clinic for these assessments.

4 end of treatment

The treatment phase will continue as per the study’s timeline, which is estimated to conclude by June 2027. You will be informed about the end date of your participation based on when you joined the study.

After the treatment phase, there may be additional follow-up visits to monitor your health and gather further data for the study.

Who Can Join the Study?

  • Participants must have been diagnosed with Stage IIB/C cutaneous melanoma, which means a specific type of skin cancer that has been completely removed by surgery with no remaining cancer cells at the edges of the removed tissue.
  • The complete surgical removal of the melanoma must have been done within 12 weeks before joining the study. If there are delays beyond 12 weeks due to unexpected reasons, this should be discussed with the study team.
  • Participants must have had a negative sentinel lymph node biopsy, which means a test showing that the first lymph node to which cancer is likely to spread does not have cancer cells. If this test could not be done or the lymph node was not found, the participant is not eligible.
  • Participants must be free of disease, confirmed by a full physical exam within 14 days and imaging tests (like CT or MRI scans) within 4 weeks before joining the study. These tests should show no signs of cancer in the body, including the brain.
  • Participants must not have received any treatment for melanoma other than the complete surgical removal of the melanoma.
  • Participants must have recovered well from any side effects or complications from the surgery before starting the study.
  • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
  • Tumor tissue from the removed melanoma must be provided to the central laboratory before joining the study. If this is not possible, it should be discussed with the study team.
  • Participants can be of any gender.

Who Cannot Join the Study?

  • Patients who have not had their Stage IIb/c melanoma completely removed cannot participate.
  • Patients with any signs of the disease still present are not eligible.
  • Patients who are not within the specified age range for the study cannot join.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Laiko General Hospital Of Athens Athens Greece
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nice Nice France
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Grand Hopital De Charleroi Charleroi Belgium
Grand Hopital De Charleroi Charleroi Belgium
Oslo University Hospital HF Oslo Norway
Sykehuset Oestfold HF Kalnes Graalum Norway
Istituto Oncologico Veneto Padua Italy
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Tampere University Hospital Tampere Finland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Turku University Hospital Turku Finland
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Region Oerebro Laen Orebro Sweden
Centre hospitalier universitaire de Liege Liege Belgium
Universita’ Degli Studi Di Perugia Perugia Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
SRH Wald-Klinikum Gera GmbH Gera Germany
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Amphia Hospital Breda The Netherlands
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Az Maria Middelares Gent Gent Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Odense University Hospital Odense Denmark
University Hospital Ostrava Ostrava Czechia
Uniklinikum Salzburg Salzburg Austria
Hospital Hotel Dieu Nantes France
Hmmuiw Hsjjskfr Herlev Denmark
Hjwzy Bzlhko Hm Bergen Norway
Axdpse Myondkt Ctkefg Snxo Thessaloniki Greece
Agqkujxfby Pgtivnpu Hvwovswq Dw Pywgz Paris France
Aoospalpnc Pphfrdjh Hhjxbret Dd Mssdsnhpf Marseille France
Bovsnilg Updhmhjgxs Hrdqxlru Cqkaty Besançon France
Hpseyroh Uvjxdpglok Cpvsimn Hkqmlgwx Helsinki Finland
Efryfrc Uuhvjgrxlwdu Mqminat Crnzaqp Rmhwdsdkq (qsoordr Mnl Rotterdam The Netherlands
Ayhixfm Ocygoyjrzqw Uwylolblugnqt Sqpuhr Siena Italy
Axykev Ugdgtqzydp Hxujcqvg Aarhus Denmark
Luzafs Mpeleyvtzq Ucwolotxct Ov Maccdp Munich Germany
Umueuqaucsrewl Cdwncbv Ktlwszxws Gdansk Poland
Albxykd Oycfixeekrl Pnzh Gqyzgzfe Xirvx Bergamo Italy
Uzbacruvwkqr Mfmjcxd Cuaxncw Gmpltsece Groningen The Netherlands
Follepqfx Pybm Lb Ixtzbevfrylsh Bohaqfbak Dxv Hkxiwndb Uywvmojucmuov Lq Pxt Madrid Spain
Hskyesmy Uroxchwxlyhoz Hqeofaoy Touyo y Pvgpzf Inwqfimg Cnbhlm dlfacjeljoqhylnwq (kmnt Badalona Spain
Hidzpljg Uqotqcrpqtgnc dd A Citmdu A Coruna Galicia Spain
Mowiylvfxgxb Hjihhylc Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.09.2019
Belgium Belgium
Not recruiting
30.09.2019
Czechia Czechia
Not recruiting
30.09.2019
Denmark Denmark
Not recruiting
30.09.2019
Finland Finland
Not recruiting
30.09.2019
France France
Not recruiting
30.09.2019
Germany Germany
Not recruiting
30.09.2019
Greece Greece
Not recruiting
30.09.2019
Italy Italy
Not recruiting
30.09.2019
Norway Norway
Not recruiting
30.09.2019
Poland Poland
Not recruiting
30.09.2019
Romania Romania
Not recruiting
30.09.2019
Spain Spain
Not recruiting
30.09.2019
Sweden Sweden
Not recruiting
30.09.2019
The Netherlands The Netherlands
Not recruiting
30.09.2019

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, nivolumab is being tested to see if it can help prevent the return of melanoma, a type of skin cancer, after it has been completely removed by surgery. The goal is to see if nivolumab can help keep the cancer from coming back longer than if no additional treatment is given.

Investigated diseases:

Stage IIB/C Melanoma – Melanoma is a type of skin cancer that originates in the pigment-producing melanocytes. Stage IIB/C melanoma indicates a more advanced form where the tumor is thicker and may have ulceration, but it has not spread to distant sites. In this stage, the cancer is confined to the skin and possibly nearby lymph nodes. The progression involves the potential for the cancer to grow deeper into the skin and possibly spread to nearby lymph nodes. If not managed, it can advance to more severe stages where it may metastasize to other parts of the body. The focus in this stage is on monitoring for recurrence and managing any local spread.

Trial ID:
2022-502354-14-00
Protocol code:
CA209-76K
Trial Phase:
Therapeutic confirmatory (Phase III)

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