RecruitingPhase 2NCT05280457

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

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 Open-label Phase 2 Clinical Trial With Lead-In Safety Cohort


Sponsor

Yonsei University

Enrollment

21 participants

Start Date

Apr 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two treatments — a DNA vaccine (GX-188E) plus an immune-boosting injection (GX-I7) — together with the immunotherapy drug nivolumab for patients with advanced head and neck cancer caused by the HPV virus (specifically HPV-16 or HPV-18). The hope is that stimulating the immune system to recognize HPV can help shrink tumors. **You may be eligible if...** - You are 19 or older with confirmed HPV-16 or HPV-18 positive head and neck cancer that has returned or spread - Your cancer progressed during or after platinum-based chemotherapy - Your tumor shows a protein called PD-L1 at 1% or higher - You have had up to 2 prior lines of chemotherapy - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have already received immunotherapy drugs (anti-PD-1/PD-L1 agents) - You have active autoimmune disease requiring treatment - You have active brain metastases or a history of organ transplant - You are pregnant or breastfeeding - You have active HIV or hepatitis B/C infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGnivolumab-GX-188E-GX-I7

* Nivolumab 3 mg/kg IV administered every 2 weeks * GX-188E 2 mg IM at Weeks 1, 2, 4, 7, 10, 13, and 19 * GX-I7 1200 μg/kg or the recommended dose of the introductory safety cohort is administered at weeks 2, 10, and 18


Locations(1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

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NCT05280457


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