A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

Melanoma Clinical Trial

Official title:

A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608291
• Other study ID #: R3767-ONC-2055
• Secondary ID: 2022-501576-25-0
• Status: Recruiting
• Phase: Phase 3
• Start date: January 16, 2023
• Est. completion date: February 15, 2030

Study information

• Verified date: May 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab.

The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting.

The study is looking at several other research questions, including:

• What side effects may happen from receiving the study drugs.

• How much study drug is in the blood at different times.

• Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.

• How administering the study drugs might improve quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1530
• Est. completion date: February 15, 2030
• Est. primary completion date: May 16, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Key Inclusion Criteria:

1. All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol

2. Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery

3. All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol

Key Exclusion Criteria:

1. Uveal melanoma

2. Any evidence of residual disease after surgery by imaging, pathology, or cytology.

3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment

4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol

5. Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol

6. Participants with a history of myocarditis

7. Adolescent patients (=12 to <18 years old) with body weight <40 kg

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Fianlimab
Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks
• Cemiplimab
Cemiplimab will be administered by IV infusion Q 3 weeks
• Pembrolizumab
Pembrolizumab will be administered by IV infusion Q 3 weeks
• Placebo
Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks

Locations

Country	Name	City	State
Argentina	DIABAID - Instituto de Asistencia Integral en Diabetes	Ciudad Autonoma	Buenos Aires
Argentina	Fundacion CENIT para la investigacion en Neurociencias	Ciudad Autonoma	Buenos Aires
Argentina	Instituto de Oncologia de Rosario - Departamento de Investigaciones	Rosario	Santa Fe
Argentina	Centro Medico San Roque	San Miguel de Tucumán	Tacuman Province
Argentina	Clinica Viedma S.A.	Viedma	Rio Negro
Australia	Calvary North Adelaid Hospital (HPS Pharmacies)	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Andrew Love Cancer Centre, University Hospital Geelong	Geelong	Victoria
Australia	Liverpool Hospital (Cancer Therapy Pharmacy)	Liverpool	New South Wales
Australia	Alfred Health	Melbourne	Victoria
Australia	One Clinical Research	Nedlands	Western Australia
Belgium	Cliniques Universitaires Saint-Luc	Brussels	Region De Bruxelles
Belgium	Campus Kennedylaan Apotheek	Kortrijk	West-Vlaaderen
Belgium	VITAZ vzw - pharm Sara Van Opdenbosch t.a.v. apotheek	Sint Niklaas	East Flanders
Brazil	Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)	Barra da Tijuca	Rio De Janeiro
Brazil	Fundacao Pio XII - Hospital de Cancer de Barretos	Barretos	Sao Paulo
Brazil	Centro Avancado de Tratamento Oncologico (CENANTRON)	Belo Horizonte	Minas Geraise
Brazil	Hospital Erasto Gaertner	Curitiba	Parana
Brazil	ONCOSITE - CENTRO DE PESQUISA CLINICA EM ONCOLOGIA LTDA Setor Farmacia Pesquisa Clini	Ijui	Rio Grande Do Sul
Brazil	Clinica de Neoplasias Litoral	Itajai	Santa Catarina
Brazil	Instituto Joinvilense de Hematologia e Oncologia	Joinville	Santa Catarina
Brazil	Animi Unidade de Tratamento Oncologico Ltda	Lages	Santa Catarina
Brazil	Hospital Sao Vicente de Paulo - Instituto do Cancer	Passo Fundo	Rio Grande Do Sul
Brazil	Associacao Hospitalar Moinhos de Vento, Centro de Pesquisa Clinica	Porto Alegre	Rio Grande Do Sul
Brazil	CPO - Centro de Pesquisas em Oncologia	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Clinicas de Porto Alegre - UPCO- pesquisa Clinica em Oncologia do HCPA	Porto Alegre	Rio Grande Do Sul
Brazil	INCA - Brazilian National Cancer Institute	Santo Cristo	Rio De Janeiro
Brazil	Hospital Sirio-Libanes	Sao Paulo
Brazil	Instituto de Ensino e Pesquisas Sao Lucas - IEP HEMOMED	Sao Paulo	Sao Paulo Estado
Brazil	Nucleo de Pesquisa da Rede Sao Camilo (Instituto Brasileiro de Controle do Cancer)	Sao Paulo
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Dr. Everett Chalmers Hospital	Fredericton	New Brunswick
Canada	Sunnybrook Research Institute	Toronto	Ontario
Canada	University Health Network, Princess Margaret Cancer Centre	Toronto	Ontario
Chile	Clinica UC San Carlos de Apoquindo	Santiago	Metropolitana De Santiago
Chile	Oncovida	Santiago	Santiago Region Metropolitana De Santiago
Chile	Universidad Mayor - Centro Oncologia de Precision (PROFAR)	Santiago	Metropolitana De Santiago
Chile	Oncocentro APYS	Valparaiso
Czechia	Masaryk Memorial Cancer Institute, Hospital Pharmacy	Brno	South Moravian
Czechia	University Hospital Hradec Kralove	Hradec Kralove	Bohemia
Czechia	University Hospital Ostrava Pharmacy	Ostrava	Moravia Region
France	CHU Amiens-Picardie Site Sud	Amiens	Somme
France	Sainte Catherine Institut du Cancer Avignon Provence	Avignon	Province Alpes Cote d'Azur
France	CHU Jean Minjoz	Besancon Cedex	Bourgogne
France	Hopital Avicenne Service Pharmacie Secteur essais cliniques	Bobigny	Seine Saint Denis
France	Hopital Saint Andre, Pharmacie	Bordeaux	Nouvelle-Aquitaine
France	Hopital Ambroise Pare	Boulogne Billancourt	Paris
France	Centre Francois Baclesse	Caen	Normandy
France	CHU G. Montpied, Pharmacie, secteur recherche clinique	Clermont-Ferrand	Puy-de-Dôme
France	CHU HENRI MONDOR Pharmacie Secteur ESSAIS CLINIQUES	Creteil	Paris
France	Centre Georges Francois Leclerc	Dijon	Bourgogne-Franche-Comté
France	CHU de DIJON - Pharmacie Essais Cliniques	Dijon	Bourgogne-Franche-Comte
France	CHU Grenoble Alpes	La Tronche	Grenoble
France	CH Le Mans - CCS Pharmacie-essais cliniques, aile B	Le Mans	Sarthe
France	CHU Lille, Pharmacie Centrale	Lille	Nord Deparment
France	Unite de Pharmacie Clinique Oncologique (UPCO)	Montpellier	Occitanie Region
France	CHU de NANTES Hotel Dieu	Nantes	Pays De La Loire Région
France	Centre Hospitalier Universitaire de Nice,Hopital l Archet	Nice
France	Hopital Saint Louis - APHP, Service de Pharmacie - Niveau	Paris	Ile-de-France
France	CHU Charles Nicolle	Rouen
France	Institut Claudius Regaud - Pharmacie	Toulouse	Haute-Garonne
France	Gustave Roussy - Pharmacie Essais Cliniques -1	Vaillant	Ile De France
Georgia	LTD Cancer Center of Adjara Autonomic Republic	Batumi	Adjara
Georgia	High Technology Medical Center, University Clinic Tbilisi	T'bilisi	South Caucasus
Georgia	Israeli Georgian medical research clinic Helsicore	T'bilisi	South Caucasus
Georgia	LTD New Hospitals	T'bilisi	South Caucasus
Georgia	LTD Research Institute of Clinical Medicine (LLC Todua Clinic)	T'bilisi	South Caucasus
Georgia	Tbilisi Institute of Medicine (TIM)	T'bilisi	South Caucasus
Georgia	JSC K. Eristavi National Center of Experimental and Clinical Surgery	Tbilisi	South Caucasus
Germany	Campus Virchow Klinikum, Apotheke Zytostatika Studien, Charite - Universitatsmedizin Berlin,	Berlin
Germany	Katholisches Klinikum Bochum -Zentral Apotheke	Bochum
Germany	Klinikum Bremen-Ost - Studienambulanz Dermatologie	Bremen
Germany	Klinikum Darmstadt GmbH	Darmstadt	Hessen
Germany	Universitatsklinikum Carl Gustav Carus Dresden, Klinik Apotheke - building 60	Dresden	Saxony
Germany	Helios Klinikum Erfurt	Erfurt
Germany	Hautklinik Universitatsklinikum Erlangen	Erlangen	Bavaria
Germany	Universitaetsklinikum Essen, Apotheke	Essen
Germany	Universitatsmedizin Gottingen	Gottingen	Lower Saxony
Germany	UKSH-Campus Kiel	Kiel	Schleswig-Holstein
Germany	Klinikum der Stadt Ludwigshafen am Rhein	Ludwigshafen	Rhindeland Palatinate
Germany	University Medical Center Mannheim	Mannheim	Baden-Wurttemberg
Germany	Hohenzollernapotheke	Muenster	North Rhine-Westphalia
Germany	Universitaetstklinikum Muenster Central Study Coordination for innovative Dermatology (ZID)	Muenster	North Rhine-Westphalia
Germany	LMU Klinikum Munchen, Pharmacy	Munchen	Bavaria
Germany	Harzklinikum Dorothea Christiane Erxleben GmbH, Zentrale Krankenhausapotheke	Quedlinburg	Sachsen-Anhalt
Germany	Universitatsklinikum Regensburg Studienburo Dermatologie	Regensburg
Germany	Helios Kliniken Schwerin GmbH, Apotheke	Schwerin	Mecklenburg Vorpommern
Germany	University Hospital Tuebingen	Tubingen	Baden-Wurttemberg
Greece	A Oncology Dpt, Metropolitan Hospital	Athens	Pireas
Greece	Theagenio Cancer Center	Efkarpia	Thessalonili
Greece	A Oncology Dpt, Laiko General Hospital of Athens	Goudi	Athens
Greece	Bioclinic of Thessaloniki	Thessaloniki	Pylaia
Greece	Iatriko Diavalkaniko Thessaloniki, Pharmacy	Thessaloniki	Pylaia
Ireland	Beaumont Hospital	Beaumont	Dublin
Ireland	University College Cork-Cork University Maternity Hospital	Cork	Munster
Ireland	St Vincent's University Hospital	Dublin
Ireland	University Hospital Galway	Galway	Connacht
Israel	Haemek Medical Center	Afula	Northern District
Israel	Hadassah Ein Kerem Medical Center	Jerusalem
Israel	The Chaim Sheba Medical Center	Ramat-Gan	Tel Aviv
Italy	Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari	Bari	Metropolitan City Of Bari
Italy	Arcispedale SantAnna UOC Farmacia Ospedaliera Ufficio sperimentazioni cliniche, SETTORE 2B1 Presidi	Cona	Veneto
Italy	AO S.Croce E Carle	Cuneo	Piedmont
Italy	UOC del Farmaco - PO San Salvatore	L'Aquila	Abruzzo
Italy	Farmacia Ospedaliera, Instituto Europeo di Oncologia	Milan	Lombardy
Italy	Instituto Nazionale Tumori IRCCS Fondazione G. Pascale	Napoli	Campania
Italy	Universita della Campania Luigi Vanvitella	Napoli	Campania
Italy	Azienda Ospedaliero Universitaria Maggiore della Carita, Farmacia Ospedaliera	Novara
Italy	AO perugia SC Oncologia	Perugia	Umbria
Italy	Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)	Roma	Rome Province
Italy	Farmacia Ospedaliera, Fondazione Policlinico Universitario Agostini Gemeli IRCCS	Rome	Lazio
Italy	Fondazione Policlinico Campus Bio-Medico	Rome	Lazio
Italy	UOC Oncologia Medica	Taormina
Italy	Farmacia Ospedaliera - Azienda Ospedaliero Universitaria delle Marche	Torrette
Italy	Ospedale S.Chiara - APSS di Trento - Magazzino Farmacia	Trento
Italy	Clinica Malattie Infettive, Azienda Ospedaliero Universitaria	Udine	Friuli-Venezia Giulia
Mexico	Neurociencias Estudios Clinicos S. C.	Culiacan	Sinaloa
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Preparaciones Oncologicas S. C.	Leon Guanajuato	Guanajuato
Mexico	Centro de Atencion e Investigacion Clinica en Oncologia	Merida	Yucatan
Mexico	iCan Oncology Center S.A de C.V.	Monterrey	Nuevo Leon
Mexico	FAICIC S. de R.L. de C.V.	Veracruz	Veracruz Estado
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos S.A de C.V	Zapopan	Jalisco
Poland	Uniwersyteckie Centrum Kliniczne (UCK)	Gdansk	Pomeria
Poland	Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii	Siedlce	Mazowieckie
Poland	Wojewodzki Szpital Specjalistyczny im. J. Korczaka w Slupsku	Slupsk	Pomorskie
Romania	Institute of Oncology Bucharest	Bucharest
Romania	Radiotheraoy Center Cluj/Ph	Cluj	Floresti
Romania	Cardiomed	Cluj Napoca	Transylvania
Romania	Institul Oncologic Prof. Dr Ion Chiricuta	Cluj Napoca	Transylvania
Romania	Centrul de Oncologie Sf. Nectarie S.R.L/SC	Craiova	Dolj
Romania	Centrul De Oncologie Euroclinic	Ia?i	Moldava
Romania	Oncocenter-Oncologie Clinica SRL	Timisoara	Timis
Romania	Oncomed	Timisoara	Timis
South Africa	Cape Gate Oncology Trials	Cape Town	Western Cape
South Africa	The Medical Oncology Centre of Rosebank	Johannesburg	Gauteng
South Africa	Wilgers Oncology Center	Pretoria	Gauteng
Spain	Institut Catala d'Oncologia	Badalona
Spain	Area dassajos clinics/Medicaments en investigacio, Servei de Farmacia Hospital Clinic de Barcelona (ICMHO)	Barcelona	Catalonia
Spain	Hospital Universitario Quiron Dexeus Barcelona	Barcelona	Catalonia
Spain	Hospital Universitario Vall d'Hebron, Edificio General-Planta Baja, UITM, Unidad de Farmacia de Ensa	Barcelona	Catalonia
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital General Universitario Gregorio Maranon (HGUGM)	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario La Paz	Madrid	Madrid Provincia
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario Marques De Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen Macarena	Sevilla	Andalucia
Spain	Fundacion Instituto Valenciano de Oncologia	Valencia
Spain	Hospital Clinico Universitario de Valencia	Valencia
Turkey	Adana Kisla Baskent Unv Hospital	Adana	Cilicia
Turkey	Ankara Memorial Hospital	Ankara	Central Anatolia
Turkey	Liv Hospital	Ankara	Central Anatolia
Turkey	Sbu Dr. A.Y. Ankara Onkoloji Suam	Ankara	Anatolia
Turkey	Dicle University, Faculty of Medicine	Diyarbakir	Diyarbakir Province
Turkey	Istanbul Universitesi CerrahpaSa- Cerrahpasa Tip Fakultesi	Fatih	Istanbul
Turkey	Trakya Universitesi, Balkan Onkoloji Hastanesi Linik Arastirmar Odasi	Iskender	Edime
Turkey	Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul	Istanbul Province
Turkey	Izmir Katip Celebi University Ataturk training and Research Hospital	Izmir	Izmir Province
Turkey	Gulhane Egitim ve Arastirma Hastanesi	Keçiören	Ankara
Turkey	Medical Park Gaziantep Hastanesi	Sehitkamil	Gaziantep
Turkey	Kocaeli University Hospital	Umuttepe	Kocaeli
United Kingdom	Clinical Trials Unit Bristol Haematology & Oncology Centre	Bristol	Somerset
United Kingdom	Clinical research pharmacy	Chelsea	London
United Kingdom	Pharmacy Clinical Trials, Pharmacy Department, Alexander Donald Building, Western General Hospital	Edinburgh	Lothian
United Kingdom	Royal Devon University Healthcare NHS Foundation Trust, Clinical Trials Pharmacy	Exeter	Devon
United Kingdom	Pharmacy Chemotherapy Unit, St Barthomews Hospital West Smithfield	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Musgrove Park Hospital, Somerset Foundation Trust	Taunton	Somerset
United States	Massachusetts General Cancer Center	Boston	Massachusetts
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Northwestern Medical Group	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Luke's Hematology	Easton	Pennsylvania
United States	The Melanoma And Skin Cancer Institute	Englewood	Colorado
United States	Virginia Cancer Specialist Research Institute	Fairfax	Virginia
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	University of California San Diego	La Jolla	California
United States	Miami Cancer Institute	Miami	Florida
United States	Intermountain Medical Center	Murray	Utah
United States	SCRI Partners - Verdi Oncology	Nashville	Tennessee
United States	Tennessee Oncology	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	NYU Langone Health	New York	New York
United States	Orlando Health Cancer Institute	Orlando	Florida
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	University of California, San Francisco	San Francisco	California
United States	John Wayne Cancer Institute - Saint John's Health Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Czechia,  France,  Georgia,  Germany,  Greece,  Ireland,  Israel,  Italy,  Mexico,  Poland,  Romania,  South Africa,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse free survival (RSF)	Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.	Up to 5 Years
Secondary	Distant metastasis-free survival (DMFS)	Time between the date of randomization and the date of the first distant metastasis.	Up to 5 Years
Secondary	Overall survival (OS)	Time from randomization to the date of death.	Up to 5 Years
Secondary	Occurrence of treatment-emergent adverse events (TEAEs)	A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to 5 Years
Secondary	Occurrence of immune-mediated EAEs (im-EAEs)	imAEs are a unique set of toxicities thought to be caused by unrestrained cellular immune responses.	Up to 5 Years
Secondary	Occurrence of serious adverse events (SAEs)	An SAE is any untoward medical occurrence that at any dose: Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger).; Is life-threatening; Requires in-patient hospitalization or prolongation of existing hospitalization.; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect.; Is an important medical event	Up to 5 Years
Secondary	Occurrence of adverse events of special interest (AESIs)	An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it	Up to 5 Years
Secondary	Occurrence of TEAEs resulting in death	A TEAE resulting in death is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to 5 Years
Secondary	Occurrence of dose-limiting toxicity (DLT)	A DLT is defined as a study-drug related TEAE, including imAEs, that could preclude enrolling additional adolescent patients at the selected dose. Dose-limiting toxicity will be evaluated in adolescents only.	Up to 5 Years
Secondary	Occurrence of interruption or discontinuation of study drug(s) due to TEAE	A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to 5 Years
Secondary	Occurrence of laboratory abnormalities	As assessed by the NCI-CTCAE grading system (= Grade 3 or higher)	Up to 5 Years
Secondary	Concentrations of fianlimab in serum over time	The concentrations of fianlimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.	Up to 5 Years
Secondary	Concentrations of cemiplimab in serum over time	The concentrations of cemiplimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.	Up to 5 Years
Secondary	Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies	Immunogenicity will be characterized per drug molecule by ADA and NAb status.	Up to 5 Years
Secondary	Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies	Immunogenicity will be characterized per drug molecule by ADA and NAb status.	Up to 5 Years
Secondary	Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)	The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.; The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.	Up to 5 Year
Secondary	PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)	The EQ-5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Up to 5 Years
Secondary	PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma	The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-M is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).	Up to 5 Years
Secondary	PRO for adults as determined by the Patient Global Impressions Scale (PGIS)	The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".	Up to 5 Years
Secondary	PRO for adults as determined by the Patient Global Impressions of Change Scale (PGIC)	The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".	Up to 5 Years
Secondary	Time to global health status/quality of life deterioration per EORTC QLQ-C30		Up to 5 years
Secondary	Time to physical functioning deterioration per EORTC QLQ-C30		Up to 5 Years
Secondary	Time to role functioning deterioration per EORTC QLQ-C30		Up to 5 Years

External Links

•   A clinical study for adults and adolescents who are melanoma-free following surgery.