Clinical Trial Details

EORTC-1525-LCG

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Single-arm, multicenter, phase II study of immunotherapy in patients with type B3 thymoma and thymic carcinoma previously treated with chemotherapy.

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 12-Apr-2018
Date Step1 close: 25-Jan-2023
Data management at EORTC Yes
Design Phase 2
Not randomized / N.A.
Targeted Sample size EORTC Groups: 55 - All Groups: 55
Treatment Drug
Ipilimumab, Nivolumab
Study Staff Nicolas Girard (Study Coordinator) , Institut Curie- Hopital de Paris, PARIS CEDEX 05
Hadi Almidani (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Luc Boone (Statistician) , EORTC Headquarters, Brussels
Ilse Coppens (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels
Fanny Grillet (TR Scientist) , EORTC Headquarters, Brussels
Selin Gundogan (Clinical Operations Manager) , EORTC Headquarters, Brussels
Hafida Lmalem (Imaging Officer) , EORTC Headquarters, Brussels
Belma Malanda (Project Manager) , EORTC Headquarters, Brussels
Ana Oliveira (Data Manager) , EORTC Headquarters, Brussels
Solange Peters (Study Co-Coordinator) , Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne
Yassin Pretzenbacher (Statistician) , EORTC Headquarters, Brussels
Lucy Sepulveda (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Jelle Stans (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Marian Stefanica (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Yuliya Vostrikova (Clinical Data Expert) , EORTC Headquarters, Brussels
Zineb Wadid (Lead CRA) , EORTC Headquarters, Brussels
Eleni Xenophontos (Clinical Research Physician) , EORTC Headquarters, Brussels
Type of cancer Thymoma
Participating groups EORTC Lung Cancer Group
ETOP IBCSG Partners Foundation
Recruiting centers Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France)
CHU de Lyon - Hopital Louis Pradel (BRON, France)
CHU de Toulouse - Hopital Larrey (TOULOUSE CEDEX 9, France)
Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France)
Erasmus MC (Rotterdam, Netherlands)
Gustave Roussy (VILLEJUIF CEDEX, France)
Hopital Nord (APHM) (Marseille, France)
Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Institut Curie- Hopital de Paris (PARIS CEDEX 05, France)
Institut Jules Bordet (Anderlecht, Belgium)
Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Protocol summary http://clinicaltrials.gov/study/NCT03134118
NCT number NCT03134118
EudraCT 2015-005504-28
Financial Support Educational Grant