Overview

Window of Opportunity Trial of Durvalumab (MEDI4736) or Durvalumab/Tremelimumab as Neoadjuvant Chemotherapy to Identify Immune Dynamics in Surgically Resectable Head and Neck Cancer Patients.

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a phase II randomized, open label study of durvalumab with/ without tremelimumab as neoadjuvant therapy and durvalumab maintenance after SoC RTx with/without cisplatin as post-surgical adjuvant therapy in treatment naïve participants with newly diagnosed resectable LA HNSCC. The study will be conducted in conformance with Good Clinical Practices (GCP). Approximately 44 participants will be randomized in a 1:1 ratio to below two Arms
Phase:
Phase 2
Details
Lead Sponsor:
Yonsei University
Treatments:
Antibodies, Monoclonal
Cisplatin
Durvalumab
Tremelimumab