A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

May 19, 2021

Primary Completion Date

January 25, 2024

Study Completion Date

December 31, 2025

Conditions
Melanoma Stage IIIMelanoma Stage IVUnresectable Melanoma
Interventions
BIOLOGICAL

BNT111

IV injection

BIOLOGICAL

Cemiplimab

IV infusion

Trial Locations (49)

2060

Melanoma Institute Australia, Sydney

2640

Border Medical Oncology, East Albury

4215

Gold Coast Hospital, Southport

8916

Hospital Universitari Germans Trias i Pujol (HUGTP), Badalona

10060

Fondazione del Piemonte per l'Oncologia, Istituto di Candiolo (IRCCs), Candiolo

10126

AOU Citta della Salute e della Scienza di Torino, Turin

15009

Hospital Teresa Herrera (CHUAC), A Coruña

15706

Complejo Hospitalario Universitario De Santiago De Compostela, Santiago de Compostela

22031

Inova Dwight and Martha Schar Cancer Institute, Fairfax

24105

Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel Hautkrebszentrum Kiel, Kiel

28007

Hospital General Universitario Gregorio Maranon, Madrid

28033

MD Anderson Cancer Center, Madrid

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Madrid

28325

Klinik für Dermatologie, Dermatochirurgie, Allergologie, Klinikum Bremen-Ost, Gesundheitnord GmbH, Bremen

30120

Hospital Universitario Virgen de la Arrixaca, El Palmar

33136

Sylvester Comprehensive Cancer Center/ UMHC, Miami

35128

IOV - Istituto Oncologico Veneto - IRCCS, Padua

39008

Hospital Universitario Marques De Valdecilla, Santander

40138

Azienda ospedaliera universitaria Bologna, Bologna

41013

Hospital Universitario Virgen del Rocio, Seville

45147

Universitätsklinikum Essen (AoR), Essen

46026

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur), Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumpori (IRST), Meldola

53100

Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte, Siena

55131

Universitätsmedizin der Johannes Gutenberg Universität Mainz KoeR, Mainz

68167

Universitätsklinikum Mannheim GmbH, Mannheim

68310

Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha

69120

Universitätsklinikum Heidelberg, Heidelberg

70124

Istituto Di Ricovero E Cura A Carattere Scientifico - Istituto Tumori Giovanni Paolo Ii, Bari

72076

University Hospital Tübingen, Tübingen

79104

Universitätsklinikum Freiburg, Klinik füer Dermatologie und Venerologie, Freiburg im Breisgau

80131

Istituto Nazionale Tumori Fondazione Pascale - IRCCS · S.C. Oncologia Medica Melanoma, Immunoterapia Oncologica e Terapie Innovative, Napoli

80214

Uniwersyteckie Centrum Kliniczne, Gdansk

85724

University Of Arizona College Of Medicine, Tucson

90419

Klinikum Nürnberg Nord, Nuremberg

97080

Klinikum der Julius-Maximilians-Universität Würzburg, Würzburg

94158-3214

University of California, San Francisco: Helen Diller Family Comprehensive Cancer Center, San Francisco

07962

Atlantic Health System / Morristown Medical Center, Morristown

04103

Universitätsklinikum Leipzig, Leipzig

00128

Policlinico Universitario Campus Bio-Medico, Rome

31-826

Szpital Specjalistyczny im. Luwika Rydygiera w Krakowie Sp. z o.o., Krakow

71-730

Zachodniopomorskie Centrum Onkologii, Szczecin

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warsaw

08036

Hospital Clinic de Barcelona, Barcelona

08041

Hospital De La Santa Creu I Sant Pau, Barcelona

08907

Institut Català d'Oncologia l'Hospitalet, Barcelona

G12 0YN

Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board, Glasgow

M20 4BX

The Christie - The Christie NHS Foundation Trust, Manchester

TR1 3LJ

Royal Cornwall Hospital, Truro

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

BioNTech SE

INDUSTRY