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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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04526899 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
BioNTech SE |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
BioNTech Responsible Person |
Principal Investigator Affiliation | BioNTech SE |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Active, not recruiting |
Countries | Australia, Germany, Italy, Poland, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma |
Experimental: BNT111 + cemiplimab
Experimental: BNT111 monotherapy
Experimental: Cemiplimab monotherapy
Biological: - BNT111
IV injection
Biological: - Cemiplimab
IV infusion
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
University Of Arizona College Of Medicine
Tucson, Arizona, 85724
Status
Address
University of California, San Francisco: Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158-3214
Status
Address
Sylvester Comprehensive Cancer Center/ UMHC
Miami, Florida, 33136
Status
Address
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68310
Status
Address
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, 07962
Status
Address
Inova Dwight and Martha Schar Cancer Institute
Fairfax, Virginia, 22031
Status
Address
Klinikum der Julius-Maximilians-Universität Würzburg
Würzburg, , 97080
Status
Address
Border Medical Oncology
East Albury, , 2640
Status
Address
Gold Coast Hospital
Southport, , 4215
Status
Address
Melanoma Institute Australia
Sydney, , 2060
Status
Address
Klinik für Dermatologie, Dermatochirurgie, Allergologie, Klinikum Bremen-Ost, Gesundheitnord GmbH
Bremen, , 28325
Status
Address
Universitätsklinikum Essen (AoR)
Essen, , 45147
Status
Address
Universitätsklinikum Freiburg, Klinik füer Dermatologie und Venerologie
Freiburg, , 79104
Status
Address
Universitätsklinikum Heidelberg
Heidelberg, , 69120
Status
Address
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel Hautkrebszentrum Kiel
Kiel, , 24105
Status
Address
Universitätsklinikum Leipzig
Leipzig, , 04103
Status
Address
Universitätsmedizin der Johannes Gutenberg Universität Mainz KoeR
Mainz, , 55131
Status
Address
Universitätsklinikum Mannheim GmbH
Mannheim, , 68167
Status
Address
Klinikum Nürnberg Nord
Nürnberg, , 90419
Status
Address
University Hospital Tübingen
Tübingen, , 72076
Status
Address
Istituto Di Ricovero E Cura A Carattere Scientifico - Istituto Tumori Giovanni Paolo Ii
Bari, , 70124
Status
Address
Azienda ospedaliera universitaria Bologna
Bologna, , 40138
Status
Address
Fondazione del Piemonte per l'Oncologia, Istituto di Candiolo (IRCCs)
Candiolo, , 10060
Status
Address
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumpori (IRST)
Meldola, , 47014
Status
Address
Istituto Nazionale Tumori Fondazione Pascale - IRCCS · S.C. Oncologia Medica Melanoma, Immunoterapia Oncologica e Terapie Innovative
Napoli, , 80131
Status
Address
IOV - Istituto Oncologico Veneto - IRCCS
Padova, , 35128
Status
Address
Policlinico Universitario Campus Bio-Medico
Rome, , 00128
Status
Address
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, , 53100
Status
Address
AOU Citta della Salute e della Scienza di Torino
Turin, , 10126
Status
Address
Uniwersyteckie Centrum Kliniczne
Gdańsk, , 80214
Status
Address
Szpital Specjalistyczny im. Luwika Rydygiera w Krakowie Sp. z o.o.
Kraków, , 31-826
Status
Address
Zachodniopomorskie Centrum Onkologii
Szczecin, , 71-730
Status
Address
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, , 02-781
Status
Address
Hospital Teresa Herrera (CHUAC)
A Coruña, , 15009
Status
Address
Hospital Universitari Germans Trias i Pujol (HUGTP)
Badalona, , 8916
Status
Address
Hospital Clinic de Barcelona
Barcelona, , 08036
Status
Address
Hospital De La Santa Creu I Sant Pau
Barcelona, , 08041
Status
Address
Institut Català d'Oncologia l'Hospitalet
Barcelona, , 08907
Status
Address
Hospital Universitario Virgen de la Arrixaca
El Palmar, , 30120
Status
Address
Hospital General Universitario Gregorio Maranon
Madrid, , 28007
Status
Address
MD Anderson Cancer Center
Madrid, , 28033
Status
Address
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, , 28222
Status
Address
Hospital Universitario Marques De Valdecilla
Santander, , 39008
Status
Address
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago De Compostela, , 15706
Status
Address
Hospital Universitario Virgen del Rocio
Sevilla, , 41013
Status
Address
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, , 46026
Status
Address
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
Glasgow, , G12 0YN
Status
Address
The Christie - The Christie NHS Foundation Trust
Manchester, , M20 4BX
Status
Address
Royal Cornwall Hospital
Truro, , TR1 3LJ