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

PHASE2RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

March 1, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

December 31, 2025

Conditions
Head and Neck Squamous Cell Carcinoma
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, 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®

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

Trial Locations (1)

Unknown

RECRUITING

Yonsei University Health System, Severance Hospital, Seoul

Sponsors
All Listed Sponsors
collaborator

Genexine, Inc.

INDUSTRY

collaborator

NeoImmuneTech

INDUSTRY

lead

Yonsei University

OTHER

NCT05286060 - 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 | Biotech Hunter | Biotech Hunter