Study

EORTC-2022-MG

Adjuvant tebentafusp (IMCgp100) versus observation in HLA-A*02:01 positive patients following definitive treatment of high-risk uveal melanoma: an EORTC randomized phase III study

Study documentation Back to result

Trial Status

Recruiting

Dates

Date of activation: 12-Nov-2024

Data management at EORTC

Yes

Design

Phase 3
Randomized open label

Targeted Sample size

EORTC Groups: 210 - All Groups: 290

Treatment

Drug
Tebentafusp

Study Staff

  • Justine Bobinnec (Study Coordinator), EORTC Liaison Office France, Paris
  • Kirsten Brade (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Patrycja Buczak Kula (Study Coordinator), Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw
  • Agnieszka Byszek (Study Coordinator), EORTC Liaison Office Poland, Warsaw
  • Ivan Jelas (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Julie Kitcheman (Study Coordinator), EORTC Liaison Office UK , Leeds
  • Paul Nathan (Study Coordinator), East and North Hertfordshire NHS Trust – Mount Vernon Hospital, Northwood
  • Susanne Ziegler (Study Coordinator), EORTC Liaison Office Germany, Berlin
  • Richard D Carvajal (Study Co-Coordinator), Northwell Health -Center for Advanced Medicine , Lake Success
  • Serge Leyvraz (Study Co-Coordinator), Charite - Universitaetsmedizin Berlin - Campus Mitte, Berlin
  • Sophia Kreft (Y-ECI Coordinator), The Christie NHS Foundation Trust, Manchester
  • Egle Venslovaite (Project Manager), EORTC Headquarters, Brussels
  • Sandrine Marreaud (Clinical Research Physician), EORTC Headquarters, Brussels
  • Anne-Sophie Govaerts (Clinical Scientist), EORTC Headquarters, Brussels
  • Michal Kicinski (Statistician), EORTC Headquarters, Brussels
  • Emmanuelle Sidot (TR Scientist), EORTC Headquarters, Brussels
  • Carla Sureda (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Marie Delsaute (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Amaya Gonzalez (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Lien Styns (Data Manager), EORTC Headquarters, Brussels
  • Leen Wijnen (Study Designer), EORTC Headquarters, Brussels
  • Hafida Lmalem (Imaging DM), EORTC Headquarters, Brussels
  • Nathalie Elaut (Clinical Data Expert), EORTC Headquarters, Brussels
  • Zara Nasir (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Denisse Tubay (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Lore Hermans (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Salvatore Mazza (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Kevin Pilger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Miguel Remis (Lead CRA), EORTC Headquarters, Brussels
  • Youness Benyahya (Clinical Operations Assistant), EORTC Headquarters, Brussels
  • Yulia Roshchupkina (Clinical Operations Assistant), EORTC Headquarters, Brussels
  • Ana Joaquim (Independent medical representative), EORTC Headquarters, Brussels
  • Lotte van der Weijst (QoL Specialist), EORTC Headquarters, Brussels
  • Eleni Mandila (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
  • Herve Azobou (Unblinded independent statistical analyst), EORTC Headquarters, Brussels
  • Olga Basova (Unblinded independent statistician), EORTC Headquarters, Brussels
  • Corneel Coens (Unblinded independent statistician), EORTC Headquarters, Brussels

Type of cancer

  • Melanoma

Participating groups

  • EORTC Melanoma Group
  • Feinstein Institutes for Medical Research-Northwell Health

Recruiting centers

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany)
  • East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom)
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Roma, Italy)

Centers to be activated

  • CLCC - Jean Perrin (CLERMONT FERRAND , France)
  • Centre Antoine Lacassagne (NICE CEDEX 2, France)
  • Centre Eugene Marquis (RENNES CEDEX, France)
  • Cliniques Universitaires Saint-Luc (Brussels, Belgium)
  • Erasmus MC (Rotterdam, Netherlands)
  • Hospital Clinico Universitario De Valladolid (Valladolid, Spain)
  • Hospital Universitario 12 De Octubre (Madrid, Spain)
  • ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
  • IRCCS - Fondazione G. Pascale (Napoli, Italy)
  • IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy)
  • Institut Curie- Hopital de Paris (PARIS CEDEX 05, France)
  • Leiden University Medical Centre (Leiden, Netherlands)
  • Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
  • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
  • Northwell Health -Center for Advanced Medicine (Lake Success, United States of America)
  • Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
  • Sahlgrenska Universitetssjukhuset (Goteborg, Sweden)
  • St. Vincent'S University Hospital (Dublin 4, Ireland)
  • Universitaetsklinikum - Essen (Essen, Germany)
  • Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
  • Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik (Heidelberg, Germany)

Protocol summary

http://clinicaltrials.gov/study/NCT06246149

NCT number

NCT06246149