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

Phase 2

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: GX-188E, Pembrolizumab; Drug: GX-188E, GX-I7, Pembrolizumab; Drug: GX-188E, GX-I7

• Registration Number: NCT05286060
• Lead Sponsor: Yonsei University

Brief 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

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-06
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-15
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GX-188E 2mg, IM: 1st day of week 1, 2, and 4; Pembrolizumab 200mg, IV:1st day of week 1 and 4	GX-188E, Pembrolizumab	Combination of GX-188E HPV DNA Vaccine and Pembrolizumab as an Expanded Cohort
GX-188E 2mg, IM: 1st day of week 1, 2, and 4; GX-I7 1200㎍/kg	GX-188E, GX-I7, Pembrolizumab	IV:1st day of week 1 and 4, IV:1st day of week 1 and 4 Triple combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab
GX-188E 2mg, IM: 1st day of week 1, 2, and 4; GX-I7 360㎍/kg,GX-188E 2mg,	GX-188E, GX-I7, Pembrolizumab	IM: 1st day of week 1, 2, and 4; GX-I7 360㎍/kg, IM: 1st day of week 2; Pembrolizumab 200mg, IV:1st day of week 1 and 4 Triple combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab as an Expanded Cohort
GX-188E 2mg, IM: 1st day of week 1, 2, and 4; GX-I7 360㎍/kg, IM: 1st day of week 2	GX-188E, GX-I7	Combination of GX-188E HPV DNA Vaccine and GX-I7 as an Expanded Cohort

Primary Outcome Measures

Name	Time	Method
Major pathologic response	Immediately after the surgery	Evaluate the pathologic response in resected tumor tissue. The major pathologic response is defined as less than 10% viable tumors after treatment.

Secondary Outcome Measures

Name	Time	Method
Safety	UP to 5years	Based on the National Cancer Institute Common Terminology Criteria, version 5.0
Radiologic response	Immediately after the surgery	Based on Response Evaluation Criteria in Solid Tumors 1.1
Distant recurrence-free survival	UP to 5years	Time from surgical resection to distant recurrence
Recurrence-free survival	UP to 5years	Time from surgical resection to any type of recurrence
Disease-free survival	UP to 5years	Time from surgical resection to locoregional recurrence, distant recurrence, or death from any cause, whichever occurred first
Overall survival	Up to 5years	Time from date of treatment initiation to the date of death from any cause
Pathologic complete response	Right after the surgery. Up to 5 years	Defined as no residual viable tumor in the surgically resected specimen.
Locoregional recurrence-free survival	UP to 5years	Time from surgical resection to locoregional recurrence

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of