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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05352672
Other study ID # R3767-ONC-2011
Secondary ID 2021-004453-2320
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 14, 2022
Est. completion date August 31, 2032

Study information

Verified date June 2024
Source Regeneron Pharmaceuticals
Contact Clinical Trials Administrator
Phone 844-734-6643
Email clinicaltrials@regeneron.com
Is FDA regulated No
Health authority
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 REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. 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 drugs (which could make the drugs 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 1590
Est. completion date August 31, 2032
Est. primary completion date March 3, 2026
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Key Inclusion Criteria: 1. Age =12 years on the date of providing informed consent 2. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease 1. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable irAEs = grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months. 2. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population. 3. Measurable disease per RECIST v1.1 1. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available 2. Cutaneous lesions should be evaluated as non-target lesions 4. Performance status: 1. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 2. For pediatric patients: Karnofsky performance status =70 (patients =16 years) or Lansky performance status =70 (patients =16 years) 5. Anticipated life expectancy of at least 3 months Key Exclusion Criteria: 1. Uveal melanoma 2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment. 3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection 4. Unknown BRAF V600 mutation status as described in the protocol 5. Systemic immune suppression: 1. Use of immunosuppressive doses of corticosteroids (=10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder. 2. Other clinically relevant forms of systemic immune suppression 6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed. 7. History or current evidence of significant (CTCAE Grade =2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication. 8. Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they: 1. Received radiotherapy or another appropriate standard therapy for the brain metastases, 2. Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment 3. Did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment 4. Are asymptomatic with a single untreated brain metastasis <10 mm in size Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fianlimab
Intravenous (IV) infusion
Cemiplimab
IV infusion
Pembrolizumab
IV infusion
Placebo
IV infusion

Locations

Country Name City State
Argentina DIABAID - Instituto de Asistencia Integral en Diabetes Buenos Aires
Argentina Fundacion Cenit para la Investigacion en Neurociencias Buenos Aires
Argentina Clinica Adventista Belgrano Caba
Argentina Fundacion CENIT Centro Medico de Neurociencias Ciudad Autonoma de Buenos Aires
Argentina Instituto de Oncologia de Rosario Rosario
Argentina Centro Medico San Roque San Miguel de Tucuman
Australia Calvary North Adelaide Hospital Adelaide
Australia Barwon Health Andrew Love Cancer Centre, University Hospital Geelong Geelong
Australia Icon Cancer Centre Hobart Hobart
Australia The Alfred Hospital Melbourne
Australia Gold Coast University Hospital Southport
Australia The Townsville Hospital and Health Service Townsville
Australia Ballarat Oncology and Haematology Clinical Trials Unit Wendouree
Austria Medical University of Graz Graz
Austria Medical University Innsbruck Innsbruck Tyrol
Austria University Hospital St. Poelten St. Poelten
Austria Medical University Of Vienna Vienna
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium AZ Groeninge, Campus Kennedylaan Kortrijk
Belgium Clinique et Maternite Sainte-Elisabeth (CMSE) Namur
Belgium AZ Nikolaas Sint Niklaas
Brazil Fundacao Pio XII - Hospital de Amor de Barretos Barretos
Brazil Centro Avancado de Tratamento Oncologico (CENANTRON) Belo Horizonte
Brazil Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner Curitiba
Brazil Oncosite Centro De Pesquisa Clinica Em Oncologia Ijui
Brazil Clinica de Neoplasias Litoral/atarina Pesquisa Clínica Itajai
Brazil Instituto Joinvilense De Hematologia E Oncologia Joinville
Brazil Animi Unidade de Tratamento Oncologico Ltda Lages
Brazil Hospital Bruno Born Lajeado
Brazil Hospital Sao Vicente de Paulo (HSVP) Instituto do Cancer Passo Fundo
Brazil CPO - Centro de Pesquisas em Oncologia Porto Alegre
Brazil Hospital de Clinicas de Porto Alegre (HCPA) Porto Alegre
Brazil Hospital Moinhos de Vento Porto Alegre
Brazil Fundacao PIO XII - Hospital de Amor Amazonia Porto Velho
Brazil Instituto COI Rio de Janeiro
Brazil Hospital Sao Rafael Salvador
Brazil INCA - Brazilian National Cancer Institute Santo Cristo
Brazil Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Sao Jose do Rio Preto
Brazil Hemomed Sao paulo
Brazil Hospital Sirio Libanes (HSL) Sao Paulo
Brazil Sao Camilo Oncologia Sao Paulo
Canada Royal Victoria Regional Health Centre Barrie
Canada Cross Cancer Institute (CCI) Edmonton
Canada Dr. Everett Chalmers Hospital Fredericton
Canada Saskatoon Cancer Centre (SCC) Saskatoon
Canada Sunnybrook Research Institute Toronto Ontario
Canada University Health Network, Princess Margaret Cancer Centre Toronto
Chile Centro Oncologico Antofagasta Bradford Hill Norte Antofagasta
Chile Centro De Investigacion Clinica Bradford Hill Recoleta Chi
Chile Hospital Clinico Universidad de Chile Santiago
Chile Oncovida Santiago Region Metropolitana De Santiago
Chile Universidad Mayor - Centro Oncologia de Precision Santiago
Chile Oncocentro Vina del Mar
Czechia Fakultni Nemocnice Hradec Kralove Hradec Kralove
Czechia University Hospital Ostrava Ostrava
Czechia Fakultni nemocnice Kralovske Vinohrady, Dermatovenerologicka klinika Prague 10
France CHU Jean MINJOZ Besancon Cedex
France Hopital Avicenne Service de Dermatologie du Pr Caux Bobigny
France HOPITAL SAINT ANDRE Chu De Bordeaux Bordeaux Cedex
France Hopital Ambroise Pare Boulogne Billancourt
France CHU Estaing, Service de Dermatologie Clermont-Ferrand
France Hopitaux Universitaires Henri-Mondor Creteil
France CHU de DIJON - Service de Dermatologie Dijon
France Centre Hospitalier Universitaire De Grenoble Alpes Service Dermatologie Grenoble
France CH Le Mans - Plateforme de recherche clinique Le Mans
France Chru De Lille Lille Cedex
France Centre Leon Berard Lyon cedex 08
France Centre Hospitalier Universitaire de Nantes (CHU de Nantes) Hotel Dieu Nantes
France Hopital Cochin APHP Paris
France Hospices Civils de Lyon Pierre Benite Cedex
France Hopital de la Miletrie Centre Hospitalier Universitaire de Poitiers Poitiers Cedex
France CHU Charles Nicolle Dermatologie Rouen
France CHU Saint-Etienne - Hopital Nord Saint-Etienne
France Clinique Sainte Anne/Strasbourg Oncologie Liberale Strasbourg
France Institut Gustave Roussy Cancer Center DITEP Villejuif Cedex
Georgia LTD High Technology Hospital Medcenter Batumi
Georgia Israeli Georgian medical research clinic Helsicore Tbilisi
Georgia JSC K. Eristavi National Center of Experimental and Clinical Surgery Tbilisi
Georgia LLC Todua Clinic Tbilisi
Georgia LTD New Hospitals Tbilisi
Georgia LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic Tbilisi
Georgia Medulla - Clinics And Medical Centers Tbilisi
Georgia TIM -Tbilisi Institute of Medicine Tbilisi
Germany Universitatsklinikum Augsburg Klinik fur Dermatologie und Allergologie Campus Sud Augsburg
Germany Charite - Universitaetsmedizin Berlin Berlin
Germany Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB) St Josef Hospital Bochum
Germany Elbekliniken Buxtehude Buxtehude
Germany Staedtisches Klinikum Dessau Dessau
Germany Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
Germany Helios Klinikum Erfurt Klinik fur Hautkrankheiten und Allergologie Erfurt
Germany Universitatsklinik Frankfurt Frankfurt
Germany University Hospital Giessen Giessen
Germany Universitatsmedizin Gottingen Klinik fur Dermatologie Göttingen
Germany University of Kiel Kiel
Germany Universitaetsklinikum Leipzig Leipzig
Germany Universitaetsklinikum Schleswig-Holstein Campus Luebeck Luebeck
Germany University Medical Center Mannheim Mannheim
Germany Fachklinik Hornheide Muenster
Germany Universitätsklinik der Paracelsus Medizinischen Privatuniversität Nuremberg
Germany Harzklinikum, Klinik fur Dermatologie und Allergologie Quedlinburg
Germany University Clinic Regensburg Regensburg
Germany Helios Klinik Schwerin Schwerin
Germany Universitaetsapotheke Tuebingen Tuebingen
Hungary University of Debrecen Debrecen
Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Nyíregyhaza
Hungary University of Pecs Medical School Pecs
Hungary University of Szeged Szeged
Ireland Cork University Hospital Cork
Ireland St. James Hospital Dublin
Ireland St. Vincents University Hospital Dublin 4
Ireland University College Hospital Galway Galway
Italy Istituto dei Tumori Bari
Italy ASST Spedali Civili Brescia Brescia
Italy Istituto di Candiolo, FPO IRCCS Candiolo
Italy Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo Cuneo
Italy Ospedale Policlinico San Martino - IRCCS Genova
Italy Fondazione IRCCS San Gerardo dei Tintori Monza
Italy IRCCS Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale Napoli
Italy Università della Campania Luigi Vanvitella Napoli
Italy SCDU di Oncologia AOU Maggiore Della Carita Novara
Italy IOV - Istituto Oncologico Veneto - IRCCS Padova
Italy U.O. Oncologia Medica Universitaria - Istituto Toscano Tumori Polo Oncologico Pisa
Italy Istituti Fisioterapici Ospitalieri (IFO) Roma
Italy Campus Bio-Medico di Roma Rome
Italy Istituto Dermopatico Dell'Immacolata Irccs Rome
Italy Fondazione IRCSS Casa Sollievo Della Sofferenza San Giovanni Rotondo
Italy Azienda Ospedaliera S. Maria Terni
Italy Santa Chiara Regional Hospital Trento
Italy AOU Citta della Salute e della Scienza di Torino Turin
Italy Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Ospedale Udine Udine
Mexico Centro Estatal de Cancerologia de Chihuahua Chihuahua
Mexico Neurociencias Estudios Clinicos SC Culiacan
Mexico Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde Guadalajara
Mexico Preparaciones Oncologicas SC Leon
Mexico Centro De Atencion E Investigacion Clinica En Oncologia Scp Merida
Mexico iCan Oncology Center Monterrey
Mexico Centro De Estudios Y Prevencion Del Cancer A. C. Tuxtla Gutierrez
Mexico FAICIC S. de R.L. de C.V. Veracruz
Mexico Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Zapopan
Netherlands The Netherlands Cancer Institute (NKI) - Antoni van Leeuwenhoek Hospital Amsterdam
Netherlands University Medical Center Groningen Groningen
Peru Centro Medico Monte Carmelo Arequipa
Peru Hospital Goyeneche Arequipa
Peru Hospital Nacional Daniel Alcides Carrion Bellavista
Peru Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO Concepcion
Peru Instituto Nacional de Enfermedades Neoplasicas Lima
Peru Instituto Peruano de Oncologia and Radioterapia Lima
Peru Clinica Internacional San Borja San Borja
Peru Clinica Peruano Americana Trujillo
Poland Uniwersyteckie Centrum Kliniczne (UCK) Gdansk
Poland Narodowego Instytutu Onkologii im Maria Sklodowska Curie Krakow
Poland Uniwersytecki Szpital Kliniczny w Poznaniu Poznan
Poland Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii Siedlce
Poland Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka Slupsk
Poland Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow Warszawa
Romania Institute of Oncology Bucharest Bucharest
Romania SC Radiotherapy Center Cluj SRL Cluj
Romania Medisprof Cluj Napoca
Romania Cardiomed SRL Cluj-Napoca
Romania Centrul de Oncologie Sf. Nectarie S.R.L Craiova
Romania Regional Institute of Oncology Iasi
Romania SC Centrul de Oncologie Euroclinic SRL Iasi
Romania RTC Radiology Therapeutic Center SRL Otopeni
Romania Oncocenter Oncologie Clinica S.R.L Timisoara
Romania Oncomed Timisoara
South Africa Groote Schuur Hospital Cape Town
South Africa The Medical Oncology Centre of Rosebank Johannesburg
South Africa Cape Town Oncology Trials Kraaifontein
Spain Hospital Teresa Herrera-Chuac (CHUAC) A Coruna
Spain Hospital Universitari Germans Trias i Pujol (HUGTP) Badalona
Spain Catalan Institute of Oncology (ICO) Hospitalet Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Instituto Oncologico Dr Rosel Barcelona
Spain Hospital Universitario Reina Sofia Cordoba
Spain Catalan Institute Of Oncology - Girona Girona
Spain Hospital Universitario Virgen de las Nieves Granada
Spain Hospital Universitario Lucus Augusti Lugo
Spain Centro integral Oncologico HM Clara Campal Madrid
Spain Hospital Fundacion Jimenez Diaz Madrid
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Regional Universitario de Malaga Malaga
Spain Hospital Universitario Virgen de la Arrixaca Múrcia
Spain Hospital Universitario Central de Asturias Oviedo
Spain Onkologikoa San Sebastian
Spain Hospital Universitario Virgen Macarena Sevilla
Spain INCLIVA-Instituto de Investigacion Sanitaria Valencia
Spain Instituto Valenciano de Oncologia Valencia
Turkey Adana Baskent Hospital Adana
Turkey Gulhane Training and Research Hospital Ankara
Turkey Memorial Ankara Hospital Ankara
Turkey Ozel Liv Hospital Ankara
Turkey Dicle University Medical Faculty Diyarbakir
Turkey Trakya University Edirne
Turkey Gaziantep University Medical Faculty Gaziantep
Turkey Bakirkoy Sadi Konuk Training Hospital Istanbul
Turkey Bezmialem University Istanbul
Turkey Cerrahpasa Medical Hospital Istanbul
Turkey Prof. Dr. Suleyman Yalcin Sehir Hospital Istanbul
Turkey Ege University hospital Izmir
Turkey Kocaeli Universitesi Kocaeli
United Kingdom Royal Devon and Exeter Hospital NHS Trust Exeter Devon
United Kingdom Royal Surrey NHS Foundation Trust Guildford
United Kingdom Hull University Teaching Hospitals NHS Trust Hull
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds
United Kingdom Guy's Hospital London
United States Cleveland Clinic Foundation Cleveland Ohio
United States University Hospitals Seidmand Cancer Center Cleveland Ohio
United States University of Tennessee Medical Center Knoxville Tennessee
United States University of California San Diego La Jolla California
United States The Angeles Clinic and Research Institute Los Angeles California
United States Miami Cancer Institute Miami Florida
United States Atlantic Health System - Morristown Medical Center Morristown New Jersey
United States Orlando Health, Inc Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Czechia,  France,  Georgia,  Germany,  Hungary,  Ireland,  Italy,  Mexico,  Netherlands,  Peru,  Poland,  Romania,  South Africa,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR) Approximately 27 months
Secondary Overall survival (OS) Up to 96 months
Secondary Objective response rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR) or based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST) Up to 27 months
Secondary Disease control rate (DCR) Per RECIST 1.1 based on BICR or based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST) Up to 27 months
Secondary Duration of response (DoR) Per RECIST 1.1 via BICR or based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST) Up to 27 months
Secondary PFS Based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST) Up to 27 months
Secondary Incidence of Adverse Events (AEs) Including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and/ or immune-related adverse event (irAEs) Up to 90 days post last dose, approximately 6 years
Secondary Occurrence of interruption and discontinuation of study drug(s) due to AEs Including TEAEs, AESIs, and/ or irAEs Up to 90 days post last dose, approximately 6 years
Secondary Incidence of deaths Up to 6 years
Secondary Incidence of laboratory abnormalities Will be graded using the current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system (version 5.0) Up to 90 days post last dose, approximately 6 years
Secondary Concentrations of cemiplimab in serum Up to 90 days post last dose, approximately 6 years
Secondary Concentrations of fianlimab in serum Up to 90 days post last dose, approximately 6 years
Secondary Incidence of anti-drug antibodies (ADA) to fianlimab over time Up to 30 days post last dose, approximately 6 years
Secondary Titer of anti-drug antibodies (ADA) to fianlimab over time Up to 30 days post last dose, approximately 6 years
Secondary Incidence of ADA to cemiplimab over time Up to 30 days post last dose, approximately 6 years
Secondary Titer of ADA to cemiplimab over time Up to 30 days post last dose, approximately 6 years
Secondary Incidence of neutralizing antibodies (NAb) to fianlimab over time Up to 30 days post last dose, approximately 6 years
Secondary Incidence of NAb to cemiplimab over time Up to 30 days post last dose, approximately 6 years
Secondary Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) EORTC-QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. Up to 90 days post last dose, approximately 6 years
Secondary PROs as measured by EQ-5D-5L The EQ-5D-5L consists of EQ-5D descriptive system 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. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction. Up to 90 days post last dose, approximately 6 years
Secondary PROs as measured by Functional Assessment of Cancer Therapy melanoma (FACTM) (melanoma subscale only) The FACTM is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACTM 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 90 days post last dose, approximately 6 years
Secondary PROs as measured by Patient Global Impression of Severity (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 21 days post last dose, approximately 6 years
Secondary PROs as measured by Patient Global Impression of Change (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 21 days post last dose, approximately 6 years
Secondary Change in physical functioning per EORTC QLQ-C30 EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. Baseline to Week 25
Secondary Change in role functioning per EORTC QLQ-C30 EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. Baseline to Week 25
Secondary Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. Baseline to Week 25
Secondary Change in physical functioning per EORTC QLQ-C30 EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. Baseline to end of study, approximately 6 years
Secondary Change in role functioning per EORTC QLQ-C30 EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. Baseline to end of study, approximately 6 years
Secondary Change in GHS/QoL per EORTC QLQ-C30 EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. Baseline to end of study, approximately 6 years
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