Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT05286060
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:
NCT05286060
Study Brief:
Protocol Section:
NCT05286060