Study of Nivolumab and Relatlimab for Patients with Stage III-IV Melanoma After Surgery

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What is this study about?

This clinical trial is focused on studying the treatment of Stage III-IV Melanoma, a type of skin cancer that has been completely removed through surgery. The study is comparing two treatments: a combination of two medications, Nivolumab and Relatlimab, and a single medication, Nivolumab alone. These medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to see how effective the combination treatment is compared to the single medication in preventing the return of melanoma after surgery. Participants in the study will receive either the combination of Nivolumab and Relatlimab or Nivolumab alone. Some participants may receive a placebo, which looks like the treatment but does not contain the active medication. The study will last for up to 12 months, during which participants will be monitored regularly to check for any signs of the cancer returning and to assess their overall health.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the effectiveness of the treatment. The study aims to provide valuable information on whether the combination of Nivolumab and Relatlimab offers better protection against the return of melanoma compared to Nivolumab alone. This research could help improve future treatment options for people with this type of skin cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of Stage III or Stage IV melanoma that has been completely removed through surgery.

A complete physical examination and imaging studies are conducted to ensure the absence of disease.

2 randomization

Participants are randomly assigned to one of two groups: one receiving a combination of nivolumab and relatlimab, and the other receiving nivolumab alone.

This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered to each participant.

3 treatment administration

The treatment involves intravenous administration of the medication. Nivolumab is given as a 10 mg/mL concentrate for infusion, while the combination treatment includes nivolumab 240 mg and relatlimab 80 mg per vial.

The frequency and duration of the treatment are determined by the study protocol and are administered under medical supervision.

4 monitoring and follow-up

Participants are regularly monitored for any side effects or adverse reactions to the treatment. This includes routine laboratory tests and assessments by healthcare professionals.

The study aims to measure the time until any recurrence of melanoma or death, as well as overall survival and other health outcomes.

5 completion of the study

The study is estimated to conclude by November 2029. Participants will continue to be monitored until the study’s end date or until they meet specific criteria for withdrawal from the study.

Who Can Join the Study?

  • Participants must have been diagnosed with either Stage IIIA (with a tumor larger than 1 mm in a lymph node), IIIB, IIIC, IIID, or Stage IV melanoma. Melanoma is a type of skin cancer. The cancer must be completely removed by surgery, with no remaining disease, and the edges of the removed tissue must be free of cancer cells. All types of melanoma are allowed, except for melanoma of the eye. However, melanoma of the conjunctiva (a part of the eye) is considered mucosal melanoma and is allowed.
  • Participants must have no signs of the disease, confirmed by a full physical examination within 14 days before starting the study and imaging tests within 35 days before starting the study.
  • Tumor tissue from the surgery or biopsy must be collected within 90 days before starting the study and sent to a central laboratory, preferably before starting the study. A pathology report, which is a document that describes the characteristics of the tissue, must be included.
  • Participants must be at least 12 years old at the time of signing the consent form. However, if local rules do not allow people under 18 to participate, then only those 18 and older can join.
  • Participants who are 18 years or older must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but can still do light work. Participants between 12 and 17 years old must have a Lansky/Karnofsky performance score of 80% or higher, which also measures the ability to perform daily activities.

Who Cannot Join the Study?

  • Participants who have not had their Stage III or Stage IV melanoma completely removed by surgery cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Oslo Universitetssykehus HF Oslo Norway
Medizinische Hochschule Hannover Hanover Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Vienna Vienna Austria
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medical University Of Graz Graz Austria
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
SRH Wald-Klinikum Gera GmbH Gera Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Helse Stavanger HF Stavanger Norway
Johannes Wesling Klinikum Minden Minden Germany
Radiotherapy Center Cluj S.R.L. Floresti Romania
Hospital Universitario Virgen De Las Nieves Granada Spain
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Paracelsus Medizinische Privatuniversitaet Salzburg Salzburg Austria
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Odense University Hospital Odense Denmark
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Turku University Hospital Turku Finland
Aalborg University Hospital Aalborg Denmark
Gasthuiszusters Antwerpen Antwerp Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Pirkanmaan hyvinvointialue Tampere Finland
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Hospital Ostrava Ostrava Czechia
Metropolitan Hospital Athens Greece
Caqsnhplt Uotyphaqxdbauk Sxjptxhuh Woluwe-Saint-Lambert Belgium
Ulnhjhhdgoldmlwykfuxy Ellbi Ayt Essen Germany
Hikrgqko Uzzngzieyjaes Dz Bdnvzsv Badajoz Spain
Ljyhs Gmtrljv Hsgfnucn Ov Awvcvs Athens Greece
Hzbrmp Hfiwxkki Herlev Denmark
Cfaclm Hqmludplviy Uycwfskqlntsi Dv Diwsk Dijon France
Acdfnekvdb Psbnximy Haguokxi Du Mzkrrdrlr Marseille France
Alznatdh Uxnrjcraqp Hrjzjgos Lorenskog Norway
Htewjwfp Uqjucffkne Ccsmeqr Hmszmwxn Helsinki Finland
Axzkfrg Ovwiprbvrza Ucgiqsarayufd Sfcwgq Siena Italy
Hdfqflvs Urfgjzivgyyqr Dsyrpjkv Donostia / San Sebastian Spain
Klsxgmvz dhm Uxwhqsrelogl Mbgtvsnv Avw Munich Germany
Ugdtyftthassiopptaywr Wojwotwgl Arg Wuerzburg Germany
Haqppmwy Vdqv dknqgama Barcelona Spain

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
30.09.2021
Belgium Belgium
Not recruiting
30.09.2021
Czechia Czechia
Not recruiting
30.09.2021
Denmark Denmark
Not recruiting
30.09.2021
Finland Finland
Not recruiting
30.09.2021
France France
Not recruiting
30.09.2021
Germany Germany
Not recruiting
30.09.2021
Greece Greece
Not recruiting
30.09.2021
Italy Italy
Not recruiting
30.09.2021
Norway Norway
Not recruiting
30.09.2021
Romania Romania
Not recruiting
30.09.2021
Spain Spain
Not recruiting
30.09.2021
Sweden Sweden
Not recruiting
30.09.2021

Trial locations

Investigated drugs:

Nivolumab is a type of immunotherapy used in this trial. It works by helping the immune system recognize and attack cancer cells. It is used after the complete surgical removal of melanoma to help prevent the cancer from coming back.

Relatlimab is another immunotherapy drug being tested in combination with Nivolumab. It is designed to enhance the immune response against cancer cells. In this trial, it is used together with Nivolumab to see if the combination is more effective than Nivolumab alone in preventing the return of melanoma after surgery.

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It is characterized by the uncontrolled growth of these cells, often appearing as a new or changing mole on the skin. Melanoma can progress from a localized stage, where it is confined to the skin, to more advanced stages where it spreads to other parts of the body, such as lymph nodes or distant organs. The disease is categorized into stages, with Stage III indicating regional spread and Stage IV indicating distant metastasis. Early detection and complete surgical removal of the tumor can be crucial in managing the disease. However, even after complete resection, there is a risk of recurrence, which can occur locally, regionally, or at distant sites.

Trial ID:
2023-507688-20-00
Protocol code:
CA224-098
NCT ID:
NCT05002569
Trial Phase:
Therapeutic confirmatory (Phase III)

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