60
Participants
Start Date
May 28, 2018
Primary Completion Date
May 31, 2026
Study Completion Date
May 31, 2028
Pembrolizumab
"Neo-adjuvant therapy :~* Anti-PD1 antibody will be used (pembrolizumab, Merck®) intravenously at a dose of 200 mg every 3 weeks. The patient will receive 4 injections maximum over 12 weeks. According to the investigator's opinion, the 4th injection might be cancelled in order to perform surgery from week 10 and not after week 13.~* Tumor response will be assessed 2 weeks after the last injection both clinically and radiologically (by CT-scan and MRI).~Maintenance therapy by anti-PD1 antibody (pembrolizumab, Merck®) will be then used intravenously at a dose of 200 mg every 3 weeks for a maximum period of one year, starting one month after the end of radiotherapy."
Surgery
Surgery will be performed (endoscopically if possible) 3 weeks after the last injection, at the earliest week 10 and at the latest at week 13 and will be completed by radiotherapy using IMRT technology according to the International and European Rhinologic Societies guidelines.
IMRT
Surgery will be performed (endoscopically if possible) 3 weeks after the last injection, at the earliest week 10 and at the latest at week 13 and will be completed by radiotherapy using IMRT technology according to the International and European Rhinologic Societies guidelines.
Lenvatinib
up to 26 evaluable patients will be treated with pembrolizumab combined with orally lenvatinib at a daily dose of 20 mg for 6 weeks started on the day of the first anti-PD1 dose.
RECRUITING
Gustave Roussy, Villejuif
Gustave Roussy, Cancer Campus, Grand Paris
OTHER