Study Comparing Subcutaneous and Intravenous Nivolumab and Relatlimab for Patients with Untreated Metastatic or Unresectable Melanoma

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What is this study about?

This clinical trial is focused on studying a type of skin cancer called metastatic or unresectable melanoma, which means the cancer has spread to other parts of the body or cannot be removed with surgery. The study is testing a treatment that combines two medications, nivolumab and relatlimab. These medications are given in two different ways: one is a solution for infusion, which is administered directly into a vein, and the other is a solution for injection, which is given under the skin. The purpose of the study is to see if the amount of these medications in the body is the same when given under the skin compared to when given into a vein.

Participants in the study will receive either the intravenous or subcutaneous form of the medication. The study will monitor how the body absorbs the medications and will also look at how well the cancer responds to the treatment. This includes checking if the cancer decreases in size or disappears after treatment. The study will take place over a period of time, and participants will be closely observed to ensure their safety and to gather information about the effectiveness of the treatment.

The trial is open to individuals who have not received prior systemic treatment for their melanoma, except for certain previous therapies if any side effects have stabilized. The study aims to provide valuable information on whether the subcutaneous method of administering the medications is as effective as the intravenous method, potentially offering a more convenient option for patients in the future.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the study.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes checking your age, weight, and performance status, which measures your ability to perform daily activities.

Your medical history will be reviewed to ensure you have not received prior systemic anticancer therapy, except for certain previous treatments if any side effects have stabilized.

3 treatment assignment

You will be randomly assigned to receive either the subcutaneous (under the skin) or intravenous (into the vein) form of the study drugs, nivolumab and relatlimab.

4 treatment administration

If assigned to the intravenous group, you will receive a solution for infusion containing nivolumab 240 mg and relatlimab 80 mg per vial.

If assigned to the subcutaneous group, you will receive an injection containing nivolumab 960 mg, relatlimab 320 mg, and additional components per vial.

The frequency and duration of administration will be explained to you by the study team.

5 monitoring and follow-up

Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and tests to measure the amount of the study drug in your body and assess the response of your melanoma.

The study aims to determine if the subcutaneous administration is as effective as the intravenous method.

6 completion of the study

Upon completion of the study, you will undergo a final assessment to evaluate your overall health and the effects of the treatment.

The study is expected to conclude by August 2026, and you will be informed of any relevant findings or follow-up actions.

Who Can Join the Study?

  • Must be 12 years of age or older. If you are between 12 and 18 years old, you must weigh at least 40 kg (about 88 pounds).
  • Must have an ECOG performance status of 0 or 1 or a Lansky Performance Score of 80% or higher if you are between 12 and 18 years old. This score describes your ability to take care of yourself and do daily activities like walking or working.
  • Must have a confirmed diagnosis of Stage III or Stage IV melanoma. Stage III means the cancer cannot be removed with surgery, and Stage IV means the cancer has spread to other parts of the body.
  • Must not have received any prior systemic anticancer therapy, except for certain previous treatments for melanoma if all side effects have returned to normal or stabilized.
  • Must have measurable disease according to RECIST v1.1, which is a standard way to measure how well a cancer patient responds to treatment.

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 certain other medical conditions may not be eligible. Please discuss your medical history with the study team.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to give informed consent are not eligible.
  • Patients who are participating in another clinical trial may not be 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
Universitaetsklinikum Regensburg AöR Regensburg Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Philipps-Universitaet Marburg Marburg Germany
Oslo University Hospital HF Oslo Norway
Hospital General Universitario De Valencia Valencia Spain
Centre Hospitalier De La Cote Basque Bayonne France
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Grand Hopital De Charleroi Charleroi Belgium
Ostfold Hospital Trust Fredrikstad Norway
Klinikum Nuernberg Nürnberg Germany
Centre Hospitalier Universitaire Rouen Rouen France
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Tampere University Hospital Tampere Finland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Turku University Hospital Turku Finland
Pratia S.A. Skorzewo Poland
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
CHU Gabriel-Montpied Clermont Ferrand France
Centre hospitalier universitaire de Liege Liege Belgium
Klinikum Dortmund gGmbH Dortmund Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Charite Research Organisation GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Muehlenkreiskliniken AöR Minden Germany
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Hospital Universitario De Jaen Jaen Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Nordlandssykehuset HF Bodo Norway
Fundacion Onkologikoa Fundazioa Donostia / San Sebastian Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Hospital Ostrava Ostrava Czechia
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Cddyva Hkbdarkpfbq Uydqtpmgijojy Dn Djpps Dijon France
Avrnjizzhx Pnlasmrt Hovrpvvm Df Pztmu Paris France
Aypgnoa Osdolcsjubg Urdrcevmwpzno Seamyw Siena Italy
Cxmhmbqyp Ugtzusjqjvdkao Sukblyjnd Woluwe-Saint-Lambert Belgium
Cawn dq Ttqvdy Hsgwaro Tlwajigqj Chambray Les Tours France
Akjhsmuyhy Pidcxsls Hdsqecyj Du Mmtpqmlyd Marseille France
Ajqryhpv Ukzhcjbqri Hucazmwd Lorenskog Norway
Hnnggjkz Udtadkegqd Cbssthj Haypoubb Helsinki Finland
Gfaoyx Urpsehwirl Feczclniz Frankfurt Germany
Ujxophnooq Mixfydm Chitfz Hqjwemxondedraeuc Hamburg Germany
Upgerftrcmcjyejqihmft Esxrm Ayw Essen Germany
Ilsnlpqv Ceczpw Dbsyvlscyypymmdhv L'hospitalet De Llobregat Spain
Hienjlgo Vyii dsrihlps Barcelona Spain
Hjdeyxto Ueskyvgvoamjr dk A Cethwa A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
31.03.2023
Belgium Belgium
Recruiting
31.03.2023
Czechia Czechia
Recruiting
31.03.2023
Finland Finland
Recruiting
31.03.2023
France France
Recruiting
31.03.2023
Germany Germany
Recruiting
31.03.2023
Italy Italy
Recruiting
31.03.2023
Norway Norway
Recruiting
31.03.2023
Poland Poland
Recruiting
31.03.2023
Spain Spain
Recruiting
31.03.2023
Sweden Sweden
Recruiting
31.03.2023

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is being tested to see how well it works when given under the skin compared to directly into a vein for treating melanoma, a type of skin cancer.

Relatlimab is another immune checkpoint inhibitor that is used in combination with nivolumab. It helps to further enhance the immune system’s ability to fight cancer by targeting a different pathway than nivolumab. This combination is being studied to determine if it is as effective when administered under the skin as it is when given intravenously for patients with melanoma.

Investigated diseases:

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. It often appears as a new mole or a change in an existing mole, and it can be identified by its irregular shape, multiple colors, and larger size. As melanoma progresses, it can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease can be classified as metastatic when it spreads beyond the original site to distant organs. Unresectable melanoma refers to a stage where the cancer cannot be surgically removed due to its location or extent. Early detection and monitoring of changes in the skin are crucial for managing melanoma.

Trial ID:
2022-500967-11-00
Protocol code:
CA224-127
Trial Phase:
Therapeutic confirmatory (Phase III)

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