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

Open-label Phase II 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 (Expanded Cohort)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

\<Preoperative medication\> \[GX-188E 2mg: 1st day of week 1, 2, and 4; GX-I7 360㎍/kg or 1200㎍/kg: 1st day of week 2; Pembrolizumab 200mg: 1st day of week 1 and 4\] Drug 1: GX-188E (Cohort I, II, III, IV) GX-188E, 2mg (1.0mg/0.5ml/vial), Intramuscular administration (IM) using electroporator Drug 2: GX-I7 (Cohort I, III, IV) GX-I7 360㎍/kg or 1200㎍/kg (Varies by cohort), intramuscular administration (IM) Drug 3: Pembrolizumab (Cohort I, II, III) pembrolizumab 200mg (100mg/4mL/vial), Intravenous administration (IV) \<Operation\> Surgery 2 to 8 weeks after completion of the test medication. \<Posr OP CCRT\> Physician's discretion

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2022-03-18
• Last updated: 2026-02-09

Locations

1 site across 1 country: South Korea