Study

EORTC-1652-CLTG

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

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
Atezolizumab

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