NCT03313206

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

Phase II Multicentric Study: Efficacy Evaluation of Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy on Disease-free-survival (DFS) in Patients With Resectable Head and Neck Mucosal Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective will be to estimate the disease free survival (DFS) of patients with resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 (in combination or not with lenvatinib) followed by surgery, radiotherapy and maintenance immunotherapy in order to compare it to historical DFS results of this kind of patients treated by surgery and radiotherapy. Our primary end-point will be disease-free survival at 2 years

Conditions

• Head and Neck Mucosal Melanomas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-28
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2017-10-18
• Last updated: 2026-01-20

Locations

1 site across 1 country: France