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Phase II trial of atezolizumab (anti-PD-L1) in the treatment of stage IIb-IV mycosis fungoides/sezary syndrome patients relapsed/refractory after a previous systemic treatment

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 12-Sep-2018
Date Step1 close: 21-Nov-2019
Data management at EORTC Yes
Design Phase 2
Not randomized / N.A.
Targeted Sample size EORTC Groups: 29 - All Groups: 29
Treatment Drug
Study Staff Robert Knobler (Study Coordinator) , Universitaetsklinikum Wien - AKH unikliniken, Vienna
Rudolf Stadler (Study Coordinator) , Muehlenkreiskliniken Johannes Wesling Klinikum Minden, Minden
Jose Casas (TR Scientist) , EORTC Headquarters, Brussels
Leslie Herman (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Jammbe Musoro (Statistician) , EORTC Headquarters, Brussels
Valentina Pomella (Clinical Operations Manager) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Denisse Tubay (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Type of cancer Primary Cutaneous Lymphomas
Participating groups EORTC Cutaneous Lymphoma Tumor Group
Recruiting centers APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France)
Athens University - Attikon University General Hospital (Athens, Greece)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro (Torino, Italy)
Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
Hospital Del Mar (Barcelona, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Muehlenkreiskliniken Johannes Wesling Klinikum Minden (Minden, Germany)
UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom)
UniversitaetsSpital Zurich - Division of Dermatology (Zurich, Switzerland)
Protocol summary
NCT number NCT03357224
EudraCT 2017-003680-35
Financial Support Educational Grant