drugset / Trial / NCT03313206

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

NCT03313206 ↗

Phase 2 Active not recruiting 60 enrolled Gustave Roussy, Cancer Campus, Grand Paris
Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start
2018-05-28
Primary completion
2027-01
Completion
2029-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 20 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications