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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 — GENUINE  

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05286060
Study type Interventional
Source Yonsei University
Contact Hye Ryun Kim
Phone +82-2-2228-8125
Email nobelg@yuhs.ac
Status Recruiting
Phase Phase 2
Start date March 1, 2022
Completion date December 2025
View Details
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