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

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Verified Sites

Other Sites

Site Name City Country Status
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Hospital General Universitario De Valencia Valencia Spain
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire Rouen Rouen France
Turku University Hospital Turku Finland
Centre Hospitalier Universitaire De Nantes Nantes France
University Hospital Olomouc Olomouc Czechia
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
University Hospital Ostrava Ostrava Czechia
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Uroymklwlcthdhiiettiz Rlzjjcffjk Aak Regensburg Germany
Cphlmh Haewduidaaw Ukhgdmjevgddw Do Danhx Dijon France
Azokzjjhxi Pyhipxjt Hzvhscfy Do Pwffp Paris France
Rwmckd Szbtm Sljhtn Uxzyffmamxupobtvgij Lund Sweden
Pmkfmznyrgdbwxvdkaxmz Mypyroq Marburg Germany
Abxgdwr Onbnqqveyts Upshkpylzlwhr Suxqwi Siena Italy
Odzz Uxvuzgtkqt Hazwfbar Hm Oslo Norway
Cvtsmo Hoanqolcgme Da Lb Czsb Bxyxhi Bayonne France
Uyxstysulaahpfbrinhkl Hszhjmuxmd Agp Heidelberg Germany
Courla Hueudelwnni Uvsuetkbhymri Anvawk Pgnnzgki Amiens France
Gibkp Hacildg Da Chbfolozu Charleroi Belgium
Oazgljo Hqzqpuvl Tmglx Fredrikstad Norway
Chkwpuzgh Utjblohhlsrqtq Sdkjfignh Woluwe-Saint-Lambert Belgium
Kmbdjwta Nfwwulatr Nürnberg Germany
Nlg Lip Ggeerghjgt Rqllwq Mlwmw Ghps St. Poelten Austria
Cket db Tcnebs Hshyada Thlcinfkg Chambray Les Tours France
Uknytiyaebekkymfnsfsh Tfetggtvi Aie Tuebingen Germany
Tpfuize Uaqgkkgwzh Hekjqsxj Tampere Finland
Attdrlxdsd Pmgpxveg Hxdoorne Df Mqnypfpjl Marseille France
Accezdel Uqeyavxjmu Hcwkerqv Lorenskog Norway
Njytidsu Ipojwrna Oltovhynr Igo Mbeyp Sgkuyrdnoandlasonchjmbxahovi Iftrhzjs Bfhhlolw Warsaw Poland
Hqobbxrs Ugpwllsxjd Cyrbkal Hldntjvt Helsinki Finland
Fzlbaepb Nxkbakwjl Kkjsoynbh Vdqinrenu Prague Czechia
Ivohy Orqjrwyy Pnxlkkxvaeb Suy Mfuxbhq Genoa Italy
Pxncte Stzm Skorzewo Poland
Jtmihyxrglyexxfhbpviahhtab Gckahjg Giessen Germany
Gddzoe Ulawtcevrf Fjquemfom Frankfurt Germany
Chehnuf Oilnkmsgz Iji Pzgjd Fehmgtnkye Llhphdkmqkz W Bdckvdpffk Bydgoszcz Poland
Ugkcgisbxp Mukcabl Ccxolu Hiwwpeogylyhxgjsl Hamburg Germany
Uqzhxdyilisleajabafgw Symtrlvzdjnihmtiuk Agh Kiel Germany
Esiu Khejycan Sygehxdfwuhxmpf grjgz Buxtehude Germany
Cgmdyl Hrftqyagcey Lakw Swa Pierre Benite France
Hskmrsqf Uzhbzacbqgvpz 1y Da Oyykwut Madrid Spain
Hvbrpkmd Szsjr Mmfky Dtkpb Mptqlxojtwvb Perugia Italy
Ixdahhsf Cbzeuw Dkitnpbkqmkgagito L'hospitalet De Llobregat Spain
Ikuqjoof Tchxeo Bclr Gpccaebu Pujqq Ir Bari Italy
Fekyvnayz Iajkdlglp Vyjdeeocgb Db Orjxounyh Valencia Spain
Mthlyoyqblyleqmuffef Arl Minden Germany
Osdhevfy Ccmrnav Oydkwwcin Ivb Pfckh Tazptrkp Kiqgkyqhsigubx W Ohdsu Sugnzdhvaud Pkyhkwazo Zvzvgi Oxhwbq Zjimfplapm Opole Poland
Hxavywqt Ukkfgbytpkydj Dn Jany Jaen Spain
Nhvzxlpppqzvqusyyy Hz Bodo Norway
Fjxacllpt Oesknlsfggt Fvhyooxuh Donostia / San Sebastian Spain
Fuztjcjjml Idyxzoyyjy Itrcauus Nbhnmgdeaij Busaz Milan Italy
Hnutyxag Vxjj dnvkbjmo Barcelona Spain
Csyyzm Du Ljavf Ctnznb Lj Covsdk Egmqat Mmzwvkq Rennes France
Hbfjnwih Uldenzlrwaxpt dg A Cuuzwx A Coruna Galicia Spain
Hnmztxhv Cwanmx Dw Bwwwofxtc Barcelona Spain
Cculwtu Uuzaygrdfblcbheosspl Bjpoqy Knj Berlin Germany
Cxu Df Ldpzf Liege Belgium
Kgfbxwwe Dhsacqwu gvxme Dortmund Germany
Uboatbdeztlvgijgweirx Ueh Arx Ulm Germany
Vxphicngk Fdhifrrp Nhpmjuiuu V Pfzyq Prague Czechia
Uukfthkadihbqjpzxgufh Elptu Alm Essen Germany

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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