Study of Fianlimab and Cemiplimab for Patients with Untreated 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 patients who have not received prior treatment for advanced stages of the disease. The study is comparing the effectiveness of a new treatment combination of two medications, Fianlimab and Cemiplimab, against another medication called Pembrolizumab. Fianlimab is a solution for injection, while Cemiplimab and Pembrolizumab are concentrates for solution for infusion, which means they are given through a vein. The purpose of the study is to see if the combination of Fianlimab and Cemiplimab is better than Pembrolizumab in helping patients live longer without the cancer getting worse.

Participants in the study will receive either the combination of Fianlimab and Cemiplimab or Pembrolizumab. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will last for up to 24 months, during which time participants will receive regular treatments and check-ups to monitor their health and the progress of the melanoma. The study aims to gather information on how well the treatments work and their safety, including any side effects that may occur.

This trial is important for understanding how these medications can help people with melanoma, especially those who have not been treated before for advanced stages of the disease. By participating, researchers hope to find better ways to manage melanoma and improve the quality of life for patients. The study will also collect data on how the medications affect the body, including the presence of any antibodies, which are proteins made by the immune system in response to the medications.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of melanoma, and previous treatments.

The study involves patients with advanced melanoma who have not received prior systemic therapy for their condition.

2 treatment assignment

Participants are randomly assigned to receive either a combination of fianlimab and cemiplimab or pembrolizumab alone.

The objective is to compare the effectiveness of the combination therapy against pembrolizumab.

3 medication administration

Fianlimab and cemiplimab are administered as a solution for infusion through a vein (intravenous use).

Pembrolizumab is also given as a concentrate for solution for infusion intravenously.

The frequency and dosage of these medications are determined by the study protocol and are administered under medical supervision.

4 monitoring and assessments

Regular monitoring is conducted to assess the progression of the disease and the body’s response to the treatment.

Assessments include measuring progression-free survival, overall survival, and response rates.

Patient-reported outcomes are also evaluated to understand the impact on quality of life.

5 completion of the study

The study is expected to continue until April 2031, with regular follow-ups and assessments throughout the duration.

Upon completion, data collected will contribute to understanding the effectiveness and safety of the treatments.

Who Can Join the Study?

  • You must be at least 12 years old on the day you agree to join the study.
  • You should have a type of skin cancer called melanoma that is at an advanced stage (Stage III or IV) and cannot be removed by surgery. You should not have received any previous treatment for this advanced stage, except in certain cases where you had treatment before surgery or after surgery and did not have worsening of the disease.
  • Your cancer must be measurable according to specific guidelines. If you had radiation treatment before, those areas can only be counted if they have shown signs of getting worse and there are no other areas to measure.
  • You need to be in good physical condition. For adults, this means being able to carry out normal activities or being slightly limited. For children, they should be able to do most activities for their age.
  • You should be expected to live for at least 3 more months.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than melanoma cannot participate. Melanoma is a type of skin cancer.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to follow the study procedures or instructions cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who have received certain treatments for melanoma recently may not be eligible.
  • Patients who have an active infection or illness that requires treatment cannot participate.
  • Patients who have a history of certain heart conditions may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Klinikum Nuernberg Nürnberg Germany
IRCCS Humanitas Research Hospital Rozzano Italy
University Of Debrecen Debrecen Hungary
Institutul Regional De Oncologie Iasi Iasi Romania
University Hospital Ostrava Ostrava Czechia
Hospital Universitario da A Coruna A Coruna Galicia Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Medical University Of Vienna Vienna Austria
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Medical University Of Graz Graz Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino Turin Italy
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Centre Hospitalier Universitaire De Lille Lille France
Klinikum der Universitaet Muenchen AöR Munich Germany
University Of Szeged Szeged Hungary
Universitaet Leipzig Leipzig Germany
Uniwersyteckie Centrum Kliniczne Gdansk Poland
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Medizinische Universitaet Innsbruck Innsbruck Austria
Centre Leon Berard Lyon France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Institut Gustave Roussy Villejuif France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
I.F.O. Istituti Fisioterapici Ospitalieri Rome Italy
Technische Universitaet Dresden Dresden Germany
Universitair Medisch Centrum Groningen Groningen The Netherlands
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Universita Degli Studi Di Brescia Brescia Italy
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz Madrid Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Vitaz Sint-Niklaas Belgium
Hospital Universitario Hm Sanchinarro Madrid Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Hospital Universitario Virgen De Las Nieves Granada Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
CHU Grenoble Alpes La Tronche France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Istituto Oncologico Veneto Padua Italy
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institut de Cancérologie Hématologie Universitaire de Saint Etienne (iCHUSE) Saint Priest En Jarez France
Universitaetsklinikum Regensburg AöR Regensburg Germany
Centre Hospitalier Universitaire De Dijon Dijon France
Universita’ Campus Bio-medico Di Roma Rome Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Centre Hospitalier Le Mans Le Mans France
Besancon University Hospital Center Besançon France
Universitaetsmedizin Goettingen Goettingen Germany
University Hospital Galway Galway Ireland
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Hospital Universitario Donostia Donostia / San Sebastian Spain
Hospital Universitario Lucus Augusti Lugo Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Cracow Poland
Goethe University Frankfurt Frankfurt Germany
St Vincent’s University Hospital Dublin Ireland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Of Pecs Pecs Hungary
Netherlands Cancer Institute Amsterdam The Netherlands
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Fondazione Luigi Maria Monti Rome Italy
Cork University Hospital Cork Ireland
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Katholisches Klinikum Bochum gGmbH Bochum Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland

Other Sites

Site Name City Country Status
Medisprof S.R.L. Cluj Napoca Romania
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Ukjdjwrgumutabauhkxay Mmgpttpl Ggil Mannheim Germany
Cqbknv Hzkreidprqs Uopxmhqygcarn Dxidgp Gwrhnfe Suhujaftopjracqngeidzuxuup Namur Belgium
Aqcomquu Zhhkrxbmcg Gdpyxkjdy Kortrijk Belgium
Uhniobmssjmpwkicocoq Sum Pxpmep St. Poelten Austria
Cghzppuvl Slqcaj Iasi Romania
Cydqluj Dw Ouwovvneoxteapcxvhpd Shhkvy Iasi Romania
Cobdgz dr Rdwoxhdkedlpk &fvdjyq Clvozfpz Szujsx Asbb STRASBOURG, Alsace France
Oxpworxtpn Ooxtqvwfn Cpunhwy Scabqh Timisoara Romania
Orfcccd Sepmww Timisoara Romania
Rbenpdnbp Ttmdslhktmt Csmlqo Snactb Otopeni Romania
Hqkvndueqxvq Dzulguzj Ctyudglosd Ezofjqxi Gdor Quedlinburg Germany
Hexzss Kmzmxhea Ejjjxe Gjau Erfurt Germany
Eukl Kbcnwsdg Stqadgeddfpzile gtoih Buxtehude Germany
Sloivhirmacs Kqpmfvwo Dtxros Dessau-Roßlau Germany
Ipcprrwbk Oepocllwfq Duc Rpudmk Snxd Barcelona Spain
Rlcbdfukufne Culzjs Crkf Smsvoo Floresti Romania
Fpwccvfetv Hownwhtiy ehpp Munster Germany

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
14.07.2022
Belgium Belgium
Not recruiting
14.07.2022
Czechia Czechia
Not recruiting
14.07.2022
France France
Not recruiting
14.07.2022
Germany Germany
Not recruiting
14.07.2022
Hungary Hungary
Not recruiting
14.07.2022
Ireland Ireland
Not recruiting
14.07.2022
Italy Italy
Not recruiting
14.07.2022
Poland Poland
Not recruiting
14.07.2022
Romania Romania
Not recruiting
14.07.2022
Spain Spain
Not recruiting
14.07.2022
The Netherlands The Netherlands
Not recruiting
14.07.2022

Trial locations

Fianlimab (REGN3767, Anti-Lag-3) is an investigational medication being studied for its potential to help the immune system fight cancer. It works by targeting a specific protein called LAG-3, which can slow down the immune response. By blocking this protein, fianlimab may help the immune system better recognize and attack cancer cells.

Cemiplimab is a medication that helps the immune system fight cancer by targeting a protein called PD-1 on immune cells. By blocking this protein, cemiplimab can enhance the body’s immune response against cancer cells, potentially slowing down or stopping the growth of tumors.

Pembrolizumab is a medication used to treat various types of cancer by boosting the immune system’s ability to fight cancer cells. It works by blocking a protein called PD-1, which can inhibit the immune response. By blocking this protein, pembrolizumab helps the immune system recognize and attack cancer cells more effectively.

Investigated Diseases:

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing the pigment melanin. It often appears as a new mole or a change in an existing mole, typically with irregular borders and multiple colors. Melanoma can develop on any skin surface, but it is more common in areas exposed to the sun, such as the back, legs, arms, and face. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. Early detection is crucial, as melanoma can be more effectively managed when identified in its initial stages. The disease is less common than other types of skin cancer but is more likely to grow and spread if not treated early.

Trial ID:
2023-505772-30-00
Protocol code:
R3767-ONC-2011
NCT ID:
NCT05352672
Trial Phase:
Therapeutic confirmatory (Phase III)

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