Study Comparing Relatlimab and Nivolumab Combination vs. Nivolumab Alone for Patients with Advanced Melanoma

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What is this study about?

This clinical trial is focused on studying a type of skin cancer called melanoma, specifically in cases where the cancer has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). The study is investigating the effectiveness of two treatments: nivolumab, which is already used to treat melanoma, and a combination of relatlimab and nivolumab. Nivolumab is a medication that helps the immune system fight cancer cells, and relatlimab is being studied for its potential to enhance this effect.

The purpose of the study is to compare how well patients do when treated with the combination of relatlimab and nivolumab versus nivolumab alone. Participants in the study will receive either the combination treatment or nivolumab by itself. The study is designed to be “double-blind,” meaning neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied.

Throughout the study, participants will receive their assigned treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will monitor how long participants live without their cancer getting worse, known as progression-free survival. Other aspects, such as overall survival and the response of the cancer to the treatment, will also be observed. The study aims to provide valuable information on whether the combination of relatlimab and nivolumab offers better outcomes for patients with advanced melanoma compared to nivolumab alone.

1 joining the study

Upon joining the study, eligibility is confirmed. This includes having Stage III (unresectable) or Stage IV melanoma and not having received prior systemic anticancer therapy for this condition.

Tumor tissue from an unresectable or metastatic site is required for analysis.

2 treatment assignment

Participants are randomly assigned to receive either nivolumab alone or a combination of relatlimab and nivolumab.

The study is double-blind, meaning neither the participant nor the healthcare provider knows which treatment is being administered.

3 treatment administration

The medications are administered as a solution for infusion through an intravenous route.

For the combination treatment, nivolumab is given at a dose of 240 mg and relatlimab at 80 mg per vial.

4 monitoring and assessments

Progression-free survival (PFS) is assessed to determine how long the disease does not worsen during the treatment.

Regular assessments are conducted by a Blinded Independent Central Review (BICR) to evaluate the response to treatment.

5 end of treatment

The study aims to continue until December 16, 2025, or until specific endpoints are reached.

Participants are monitored for overall survival (OS) and other outcomes such as the duration of response and any adverse events.

Who Can Join the Study?

  • Participants must have a confirmed diagnosis of Stage III (unresectable) or Stage IV melanoma. This means the cancer is advanced and cannot be removed by surgery.
  • Participants must not have received any previous treatments that affect the whole body for their unresectable or metastatic melanoma. This means they haven’t had treatments like chemotherapy or immunotherapy for this type of cancer.
  • A sample of the tumor from a site that cannot be removed or has spread must be provided for special tests called biomarker analyses. These tests help understand the cancer better.
  • Both men and women can participate in the study.
  • The study includes people from different age groups, including adults and older adults.
  • The study may include people who are considered part of a vulnerable population. This term refers to groups who might need special protection or care.

Who Cannot Join the Study?

  • Patients who have already received treatment for their melanoma cannot participate.
  • Patients with melanoma that can be surgically removed are not eligible.
  • Patients with other serious health conditions that might interfere with the study are excluded.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend required visits are not eligible.
  • Patients with a history of other cancers, unless they have been in remission for a certain period, are excluded.
  • Patients with certain infections, like HIV or hepatitis, cannot participate.
  • Patients who have had an organ transplant are not eligible.
  • Patients taking medications that might interfere with the study treatment are excluded.
  • Patients with known allergies to the study drugs 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
Oslo Universitetssykehus HF Oslo Norway
Medizinische Hochschule Hannover Hanover Germany
Medical University Of Vienna Vienna Austria
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Universitair Ziekenhuis Gent Gent Belgium
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Oulu University Hospital Oulu Finland
Fundacion Onkologikoa Fundazioa Donostia / San Sebastian Spain
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Harzklinikum Dorothea Christiane Erxleben GmbH Quedlinburg Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Hospital Clinic De Barcelona Barcelona Spain
Turku University Hospital Turku Finland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Pirkanmaan hyvinvointialue Tampere Finland
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Uniklinikum Salzburg Salzburg Austria
Lkoto Gottrkn Hgfxnfpa On Abfcrm Athens Greece
Uuxkcpenqw Hvrieeuv Ckrbsjd Cologne Germany
Hqfxya Hcaletke Herlev Denmark
Agxcwdizvs Phsuxtof Hlblcpvz Dw Pwsxh Paris France
Aerqikqdqz Pfqtjkwa Hcitiqij Dr Mtwrkqkvm Marseille France
Hfnylglm Udomuwzonz Cayipkr Hhsjaxml Helsinki Finland
Atwszxn Obqqrqengrj Ujnheuddjbrdd Snvujo Siena Italy
Nshuyjsk Ijqcnfwa Ouweqhtcv Izv Mvjmo Segdzrznexwflpulhqotpvrmewkh Iiazfxcp Bgkvzlvt Cracow Poland
Uxbfrrorlmwbygpgngjsa Wopsqzwet Ano Wuerzburg Germany
Aehozpt Ornqwgyydxl Puad Greffvgm Xshij Bergamo Italy
Hksvcjgd Vinx dyvipeuu 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
11.04.2018
Belgium Belgium
Not recruiting
11.04.2018
Denmark Denmark
Not recruiting
11.04.2018
Finland Finland
Not recruiting
11.04.2018
France France
Not recruiting
11.04.2018
Germany Germany
Not recruiting
11.04.2018
Greece Greece
Not recruiting
11.04.2018
Italy Italy
Not recruiting
11.04.2018
Norway Norway
Not recruiting
11.04.2018
Poland Poland
Not recruiting
11.04.2018
Romania Romania
Not recruiting
11.04.2018
Spain Spain
Not recruiting
11.04.2018
Sweden Sweden
Not recruiting
11.04.2018

Trial locations

Investigated drugs:

Relatlimab is an experimental medication being studied for its potential to treat melanoma, a type of skin cancer. It is being tested in combination with another medication to see if it can help slow down the progression of the disease in patients who have not received prior treatment.

Nivolumab is a medication used to treat various types of cancer, including melanoma. It works by helping the immune system recognize and attack cancer cells. In this trial, it is being used both alone and in combination with another medication to evaluate its effectiveness in treating melanoma.

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 spread to other parts of the body if not detected early, making it more challenging to treat. The disease progresses by invading nearby tissues and potentially spreading to distant organs through the lymphatic system or bloodstream. It is more common in individuals with fair skin, a history of sunburns, or excessive UV exposure. Early detection and monitoring of skin changes are crucial in managing melanoma effectively.

Trial ID:
2024-510913-13-00
Protocol code:
CA224-047
NCT ID:
NCT03470922
Trial Phase:
Therapeutic use (Phase IV)

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