Overview

HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy

Status:
Not yet recruiting

Trial end date:
2026-03-01

Target enrollment:

Participant gender:

Summary

This study is to explore the efficacy and safety of GX-188E DNA vaccination, GX-I7, and nivolumab combination therapy in HPV 16-positive and/or HPV-18 positive R/M HNSCC patients. The objective of this study is as follows. - Primary objective: Objective response rate (ORR) according to RECIST v1.1 - Secondary objectives: disease control rate (DCR) according to RECIST v1.1, progression-free survival (PFS) at 6 months, median progression-free survival (PFS), median overall survival (OS), biomarker correlation, safety and tolerability.

Phase:

Phase 2

Details

Lead Sponsor:

Yonsei University

Treatments:

Nivolumab