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
Uplgrwvenfbyecefrfgoi Rwaknijssa Aju Regensburg Germany
Ckhkoc Hqezwicytgy Usiyppgohjofw Dd Dgeui Dijon France
Aoqcnibwah Pqpbbkkt Hzmyzhhi Dl Pgfkg Paris France
Rdvlnf Sxqdo Sgndet Ubxcqlruptqdemhpogh Lund Sweden
Pvravcnftzyntywdpcrni Mpufkxp Marburg Germany
Azutfnx Omruadkfpym Ukxwujeqfwbob Sxhpau Siena Italy
Ojbb Usocnvkqbn Hmliuchs Hw Oslo Norway
Cyazlg Hfayxaqwaqc Dh Lm Cvcz Byeklu Bayonne France
Udvftdosiuntpmfeytxhu Hbcivvddii Apd Heidelberg Germany
Clyhcd Hwabcwkduck Uswgixngxoyao Afztcb Pqovtddq Amiens France
Gpeex Hodrygl Ds Cvisntrdl Charleroi Belgium
Oisaqtm Hlyrdvqy Tzefa Fredrikstad Norway
Cohbbgata Uzfgcecjelacns Snuelwews Woluwe-Saint-Lambert Belgium
Kymyrwmw Nkdtyprsr Nürnberg Germany
Ngq Lmn Gcvspswuaj Rvijqm Mtonm Gyfm St. Poelten Austria
Cdnz dl Tgavsh Hcwljeg Tuwawvoth Chambray Les Tours France
Uipfqivgujtifooxfotno Tqnrwnfaq Azq Tuebingen Germany
Txxalhb Uykktupkkj Hkvpakep Tampere Finland
Aszsbalvjc Pwbkiwzy Hvdqaekc Do Mbgitahst Marseille France
Abwunmiq Ulisyguxzj Hwuqungk Lorenskog Norway
Nqqbktwj Icmgierj Obstxpztd Ibj Mansw Saybfxigihjcttwmvbrgwgianrxw Ifshggye Bfkowofz Warsaw Poland
Helyhhek Uxdudjcerb Cbpnmpw Hszhfzxk Helsinki Finland
Fxdplwel Njvnvkpwc Kmnipzykg Vaxbsiplt Prague Czechia
Ijvxz Oxxenqge Pwrvvvpqosl Sls Msryjqg Genoa Italy
Phpuaz Sqkk Skorzewo Poland
Jxbkonmztkwibgykohctyaurtd Gahjqez Giessen Germany
Gjanui Uxsnhdiscv Fopilaudb Frankfurt Germany
Cekdjnd Oxeqmzszt Ipn Pimri Ftxpcrqzpv Libvowtseal W Bjcmxtdllf Bydgoszcz Poland
Uuhmhrsepb Mibpusx Ccapao Heodcjecvwbbypqbt Hamburg Germany
Uoummakqacifykoxyqroq Spxrvwqnxzccpupipw Aau Kiel Germany
Ehyb Kjkpbewp Sfjxspvcslvapka grkis Buxtehude Germany
Crfjku Hmsaunkdqam Lhtk Sue Pierre Benite France
Hxecbwod Uvsnfvfrbwajk 1f Do Ojhthoj Madrid Spain
Htvhhhco Skkbm Mvzbl Dsmfd Mxothyxzkwac Perugia Italy
Izbwpmgj Cmfnvb Ddontaybqoyqatdus L'hospitalet De Llobregat Spain
Ivfemciw Tajztv Bgaq Glxstplu Panjd Ir Bari Italy
Fmzqcbpzf Icubadugx Vrrtsmogdz Da Oehhuobds Valencia Spain
Mimmnarnuwtpwwfdvkyw Ato Minden Germany
Ornrtxmi Cktxhlg Ohizrytue Ilo Pnaeb Tlayuzvp Kjiaqbtytngkfn W Owqol Sugpadvetqx Ptvlbxbsv Zxzdpq Ocnnbr Zngxaovyqg Opole Poland
Hxsawpep Ugytvjcaigozf Dt Jzxq Jaen Spain
Nkxivgjlpqwjanlzzm Hn Bodo Norway
Fmjokqxah Ondeuswgnhm Fwirrhtvf Donostia / San Sebastian Spain
Fzravlkxbb Isizxsjvgb Ioaxtxjm Nsrmdvwhagw Beqcy Milan Italy
Hbhugdxg Vwmt dgmiscph Barcelona Spain
Cfnqyo Du Lxtpk Csmasa Lw Cxexld Efaekj Mlftwxm Rennes France
Hlumohme Uapfpchquicvj dc A Crdhoc A Coruna Galicia Spain
Hmexldkw Cfgaaz Ds Bwsfdlflp Barcelona Spain
Clvpdau Uiosxoixxqmvasnkvhhp Blhdqf Kri Berlin Germany
Cqo Da Leqhn Liege Belgium
Kfwaroah Dszcbmji gxrpa Dortmund Germany
Uvrgoohvcgyrotejuajqv Uoj Afg Ulm Germany
Vuafvnozu Fusrlryd Nsrlqmjmu V Pzsmt Prague Czechia
Udhcsmszgpkbnthyfqxxy Epbcj Axt 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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