Spots Global Cancer Trial Database for Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
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Trial Identification
Brief Title: Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
Official Title: Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
Study ID: NCT04526899
Study Description
Brief Summary: This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients will be randomized in a 2:1:1 ratio to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3 (cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Of Arizona College Of Medicine, Tucson, Arizona, United States
University of California, San Francisco: Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Sylvester Comprehensive Cancer Center/ UMHC, Miami, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
Atlantic Health System / Morristown Medical Center, Morristown, New Jersey, United States
Inova Dwight and Martha Schar Cancer Institute, Fairfax, Virginia, United States
Border Medical Oncology, East Albury, , Australia
Gold Coast Hospital, Southport, , Australia
Melanoma Institute Australia, Sydney, , Australia
Klinik fĂŒr Dermatologie, Dermatochirurgie, Allergologie, Klinikum Bremen-Ost, Gesundheitnord gGmbH, Bremen, , Germany
Universitaetsklinikum Essen (AoR), Essen, , Germany
Universitaetsklinikum Freiburg, Klinik fuer Dermatologie und Venerologie, Freiburg, , Germany
Medizinische Hochschule Hannover (MHH), Hannover, , Germany
UniversitÀtsklinikum Heidelberg, Heidelberg, , Germany
UniversitÀtsklinikum Schleswig-Holstein (UKSH), Campus Kiel Hautkrebszentrum Kiel, Kiel, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Universitaetsmedizin der Johannes Gutenberg Universitat Mainz KoeR, Mainz, , Germany
Universitaetsklinikum Mannheim GmbH, Mannheim, , Germany
Klinikum NĂŒrnberg Nord, NĂŒrnberg, , Germany
University Hospital Tuebingen, TĂŒbingen, , Germany
Klinikum der Julius-Maximilians-UniversitĂ€t WĂŒrzburg, WĂŒrzburg, , Germany
Istituto Di Ricovero E Cura A Carattere Scientifico - Istituto Tumori Giovanni Paolo Ii, Bari, , Italy
Azienda ospedaliera universitaria Bologna, Bologna, , Italy
Fondazione del Piemonte per l'Oncologia, Istituto di Candiolo (IRCCs), Candiolo, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumpori (IRST), Meldola, , Italy
Istituto Nazionale Tumori Fondazione Pascale - IRCCS · S.C. Oncologia Medica Melanoma, Immunoterapia Oncologica e Terapie Innovative, Napoli, , Italy
IOV - Istituto Oncologico Veneto - IRCCS, Padova, , Italy
Policlinico Universitario Campus Bio-Medico, Rome, , Italy
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte, Siena, , Italy
AOU Citta della Salute e della Scienza di Torino, Turin, , Italy
Uniwersyteckie Centrum Kliniczne, GdaĆsk, , Poland
Szpital Specjalistyczny im. Luwika Rydygiera w Krakowie Sp. z o.o., KrakĂłw, , Poland
Zachodniopomorskie Centrum Onkologii, Szczecin, , Poland
Specjalistyczny Szpital Onkologiczny NU-MED, TomaszĂłw Mazowiecki, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warsaw, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, ĆĂłdĆș, , Poland
Hospital Teresa Herrera (CHUAC), A Coruña, , Spain
Hospital Universitari Germans Trias i Pujol (HUGTP), Badalona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital De La Santa Creu I Sant Pau, Barcelona, , Spain
Institut CatalĂ d'Oncologia l'Hospitalet, Barcelona, , Spain
Hospital Universitario Virgen de la Arrixaca, El Palmar, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Madrid, , Spain
Hospital Universitario Marques De Valdecilla, Santander, , Spain
Complejo Hospitalario Universitario De Santiago De Compostela, Santiago De Compostela, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur), Valencia, , Spain
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board, Glasgow, , United Kingdom
The Christie - The Christie NHS Foundation Trust, Manchester, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Contact Details
Name: BioNTech Responsible Person
Affiliation: BioNTech SE
Role: STUDY_DIRECTOR
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