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Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer

NCT05286060 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-02-09

No results posted yet for this study

Summary

The study is open label, phase II clinical trial for the Combination of GX-188E HPV DNA Vaccine with GX-I7 or Pembrolizumab OR the Triple Combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 or 18 Positive Head and Neck Cancer.

Conditions

Interventions

DRUG

GX-188E, GX-I7, Pembrolizumab

Drug 1: GX-188E GX-188E, 2mg (1.0mg/0.5ml/vial), Intramuscular administration using electroporator Other Name: Tirvalimogene teraplasmid Drug 2: GX-I7 GX-I7 1200㎍/kg, intramuscular administration Other Name: NT-I7, rhIL-7-hyFc, efineptakin alfa Drug 3: Pembrolizumab pembrolizumab 200mg (100mg/4mL/vial), Intravenous administration Other Name: Keytruda®

DRUG

GX-188E, Pembrolizumab

Drug 1: GX-188E GX-188E, 2mg (1.0mg/0.5ml/vial), Intramuscular administration using electroporator Other Name: Tirvalimogene teraplasmid Drug 2: Pembrolizumab pembrolizumab 200mg (100mg/4mL/vial), Intravenous administration Other Name: Keytruda®

DRUG

GX-188E, GX-I7

Drug 1: GX-188E GX-188E, 2mg (1.0mg/0.5ml/vial), Intramuscular administration using electroporator Other Name: Tirvalimogene teraplasmid Drug 2: GX-I7 GX-I7 360㎍/kg, intramuscular administration Other Name: NT-I7, rhIL-7-hyFc, efineptakin alfa

DRUG

GX-188E, GX-I7, Pembrolizumab

Drug 1: GX-188E GX-188E, 2mg (1.0mg/0.5ml/vial), Intramuscular administration using electroporator Other Name: Tirvalimogene teraplasmid Drug 2: GX-I7 GX-I7 360㎍/kg, intramuscular administration Other Name: NT-I7, rhIL-7-hyFc, efineptakin alfa Drug 3: Pembrolizumab pembrolizumab 200mg (100mg/4mL/vial), Intravenous administration Other Name: Keytruda®

Sponsors & Collaborators

  • Genexine, Inc.

    collaborator INDUSTRY

  • NeoImmuneTech

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Principal Investigators

  • Hye Ryun Kim · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286060 on ClinicalTrials.gov