Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients With Resectable Head and Neck Mucosal Melanoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 28, 2018

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2028

Conditions
Head and Neck Mucosal Melanomas
Interventions
DRUG

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."

PROCEDURE

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.

RADIATION

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.

DRUG

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.

Trial Locations (1)

94805

RECRUITING

Gustave Roussy, Villejuif

All Listed Sponsors
lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER