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New vaccine combo shows promise for hard-to-treat melanoma

NCT ID NCT04526899

Completed Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a combination of an experimental cancer vaccine (BNT111) and an immunotherapy drug (cemiplimab) in 184 adults with advanced melanoma that no longer responded to standard immunotherapy. Participants were randomly assigned to receive the combination or either treatment alone. The main goal was to see how many patients' tumors shrank or disappeared. This study is for people with stage III or IV melanoma that cannot be surgically removed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MELANOMA STAGE III MELANOMA STAGE IV UNRESECTABLE MELANOMA

Contacts and locations

Locations

  • AOU Citta della Salute e della Scienza di Torino

    Turin, 10126, Italy

  • Atlantic Health System / Morristown Medical Center

    Morristown, New Jersey, 07962, United States

  • Azienda ospedaliera universitaria Bologna

    Bologna, 40138, Italy

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

    Glasgow, G12 0YN, United Kingdom

  • Border Medical Oncology

    East Albury, 2640, Australia

  • Complejo Hospitalario Universitario De Santiago De Compostela

    Santiago de Compostela, 15706, Spain

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

    Candiolo, 10060, Italy

  • Gold Coast Hospital

    Southport, 4215, Australia

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Teresa Herrera (CHUAC)

    A Coruña, 15009, Spain

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona, 8916, Spain

  • Hospital Universitario Marques De Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, 35128, Italy

  • Inova Dwight and Martha Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Institut Català d'Oncologia l'Hospitalet

    Barcelona, 08907, Spain

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

    Bari, 70124, Italy

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

    Naples, 80131, Italy

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

    Meldola, 47014, Italy

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

    Bremen, 28325, Germany

  • Klinikum Nürnberg Nord

    Nuremberg, 90419, Germany

  • Klinikum der Julius-Maximilians-Universität Würzburg

    Würzburg, 97080, Germany

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • Melanoma Institute Australia

    Sydney, 2060, Australia

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68310, United States

  • Policlinico Universitario Campus Bio-Medico

    Rome, 00128, Italy

  • Royal Cornwall Hospital

    Truro, TR1 3LJ, United Kingdom

  • Sylvester Comprehensive Cancer Center/ UMHC

    Miami, Florida, 33136, United States

  • Szpital Specjalistyczny im. Luwika Rydygiera w Krakowie Sp. z o.o.

    Krakow, 31-826, Poland

  • The Christie - The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

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

    Siena, 53100, Italy

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

    Valencia, 46026, Spain

  • University Hospital Tübingen

    Tübingen, 72076, Germany

  • University Of Arizona College Of Medicine

    Tucson, Arizona, 85724, United States

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

    San Francisco, California, 94158-3214, United States

  • Universitätsklinikum Essen (AoR)

    Essen, 45147, Germany

  • Universitätsklinikum Freiburg, Klinik füer Dermatologie und Venerologie

    Freiburg im Breisgau, 79104, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167, Germany

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

    Kiel, 24105, Germany

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz KoeR

    Mainz, 55131, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80214, Poland

  • Zachodniopomorskie Centrum Onkologii

    Szczecin, 71-730, Poland

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