21
Participants
Start Date
August 27, 2018
Primary Completion Date
March 24, 2025
Study Completion Date
March 24, 2026
Durvalumab
"All patients will be treated with postoperative radiotherapy (66 Gy in standard fractionation).~In case of positive section margins or extracapsular extension, 3 cycles of cisplatin 100 mg/msq on days 1, 22, and 43 will be added to standard fractionation radiotherapy (66 Gy).~Durvalumab monotherapy (1500 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 6 cycles postoperative."
Durvalumab + Tremelimumab
"All patients will be treated with postoperative radiotherapy (66 Gy in standard fractionation).~In case of positive section margins or extracapsular extension, 3 cycles of cisplatin 100 mg/msq on days 1, 22, and 43 will be added to standard fractionation radiotherapy (66 Gy).~Durvalumab + Tremelimumab combination therapy: Tremelimumab (75 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 3 cycles postoperative, Durvalumab (1500 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 6 cycles postoperative."
UZ Leuven, Leuven
Collaborators (1)
AstraZeneca
INDUSTRY
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Vlaams Instituut voor Biotechnologie (VIB)
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER