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

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.

Trial Details

NCT ID
NCT05280457
Phase
PHASE2
Sponsor
Yonsei University
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • nivolumab-GX-188E-GX-I7
Locations (sample)
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • 19 years of age or older
  • Histologically confirmed, advanced or metastatic, HPV-positive (positive on p16 immunohistochemistry and positive on HPV-16 or HPV-18 nucleic acid …
  • Patients with disease progression after platinum-based chemotherapy are eligible for participation.
  • Patients with recurrence within 6 months after conventional platinum-based chemotherapy are considered platinum-based treatment failure.

For full eligibility, visit ClinicalTrials.gov.

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