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

NCT05286060 | Active Not Recruiting Phase 2

• 1 other identifier: 4-2021-1786
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Major pathologic response

  Evaluate the pathologic response in resected tumor tissue. The major pathologic response is defined as less than 10% viable tumors after treatment.

  Immediately after the surgery

Secondary Outcomes (8)

• Radiologic response

  Immediately after the surgery

• Safety

  UP to 5years

• Pathologic complete response

  Right after the surgery. Up to 5 years

• Locoregional recurrence-free survival

  UP to 5years

• Distant recurrence-free survival

  UP to 5years

Study Arms (4)

GX-188E 2mg, IM: 1st day of week 1, 2, and 4; GX-I7 1200㎍/kg

EXPERIMENTAL

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

Drug: GX-188E, GX-I7, Pembrolizumab

GX-188E 2mg, IM: 1st day of week 1, 2, and 4; Pembrolizumab 200mg, IV:1st day of week 1 and 4

EXPERIMENTAL

Combination of GX-188E HPV DNA Vaccine and Pembrolizumab as an Expanded Cohort

Drug: GX-188E, Pembrolizumab

GX-188E 2mg, IM: 1st day of week 1, 2, and 4; GX-I7 360㎍/kg,GX-188E 2mg,

EXPERIMENTAL

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

Drug: GX-188E, GX-I7, Pembrolizumab

GX-188E 2mg, IM: 1st day of week 1, 2, and 4; GX-I7 360㎍/kg, IM: 1st day of week 2

EXPERIMENTAL

Combination of GX-188E HPV DNA Vaccine and GX-I7 as an Expanded Cohort

Drug: GX-188E, GX-I7

Interventions

GX-188E, GX-I7, Pembrolizumab DRUG

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®

GX-188E 2mg, IM: 1st day of week 1, 2, and 4; GX-I7 1200㎍/kg

GX-188E, Pembrolizumab DRUG

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®

GX-188E 2mg, IM: 1st day of week 1, 2, and 4; Pembrolizumab 200mg, IV:1st day of week 1 and 4

GX-188E, GX-I7 DRUG

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

GX-188E 2mg, IM: 1st day of week 1, 2, and 4; GX-I7 360㎍/kg, IM: 1st day of week 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient aged 19 or older at the time of signing the informed consent
• Histologically identified, resectable local progressive, HPV positive (positive in p16 immunohistochemistry and positive in HPV-16 and/or HPV-18 nucleic acid tests) locally advanced (LA) head and neck squamous cell carcinoma (HNSCC) patients
• A patient has never received other chemotherapy before the study
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy of \> 6 months
• Patient agreed to provide storage tumor tissue samples or fresh biopsy samples for baseline biomarker tissue analysis including PD-L1 staining during biopsy or surgery must be present. If there is no storage tissue and there is no tumor lesion that can be sampled from biopsy or surgery, it will be excluded from the test.
• Patients with suitable organ function. Samples must be collected within 28 days prior to the initiation of clinical trial drugs.
• Patient with measurable diseases defined based on RECIST v.1.1.
• For fertile woman (WOCBP), patient with negative results of serum or urine pregnancy tests conducted within 72 hours prior to the first administration of clinical trial drugs. If the urine test result is positive or cannot be confirmed negative, a serum pregnancy test should be performed.
• Fertile woman must agree to use appropriate double contraception by 120 days after the entire course of this trial and the last administration of clinical trial drugs. Woman who are menopause (over 45 years of age and have no menstruation for more than a year) and women who are surgically infertile are exempt from this requirement.
• Note: abstinence is permitted if it is the daily lifestyle of the test subject and the contraceptive method preferred by the test subject.
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

You may not qualify if:

• Unresectable metastatic or recurrent cancer.
• Patients who are currently in progress or have been confirmed to have other malignant diseases that required active treatment within the past three years.
• Note: Subjects with skin basal cell carcinoma, skin squamous cell carcinoma, or in situ carcinoma (e.g., breast cancer) that have been treated for potential complete recovery purposes are not excluded.
• Patients expected to require other forms of anti-neoplasm therapy during the test; This treatment includes systemic chemotherapy, radiation therapy, biotherapy, or immunotherapy not specified in the protocol.
• Patients with a history of active central nervous system (CNS) metastasis and/or carcinoma meningitis.
• Patients who have previously received treatment using anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or have received treatment using drugs directly acting on other irritating or co-inhibitory T cell receptors (e.g., CTLA-4, OX40, CD137).
• Patients suffering from active autoimmune diseases requiring systemic immunosuppressive treatment (e.g., use of disease modulators, corticosteroids, or immunosuppressant) within the past two years. Alternative therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement due to adrenal or pituitary dysfunction) is not considered a form of systemic therapy and is therefore acceptable.
• Patients who received homogeneous solid organ transplantation or homogeneous bone marrow transplantation.
• Patients who have been administered non-PD-1/PD-L1/PD-L2, anti-cancer monoclonal antibodies (mAb, e.g., bevacizumab, cetuximab, etc.) within 4 weeks prior to the first administration of the clinical trial drug or have not yet recovered (e.g., grade 1 or baseline level).
• Patients who received systemic chemotherapy including other clinical trial drugs within 4 weeks before the first administration of this clinical trial drug or received targeted hypogermic therapy with a half-life of less than 48 hours within 2 weeks.
• Note: The subject must have recovered to the baseline level or below in all adverse reactions caused by previous treatment. Neuropathy under grade 2 and/or anemia under grade 2 may be suitable.
• Note: If the subject has undergone major surgery, the subject must be properly recovered from toxicity and/or complications caused by the intervention prior to commencement of treatment.
• Patients who had received radiation therapy within two weeks prior to the initiation of clinical trial drugs. The test subjects must have recovered from all radiation-related toxicity.
• Patients who have transfused blood products (including platelets or red blood cells) within 4 weeks before the first administration of clinical trial drugs or have administered colony stimulation factors (Includes G-CSF, GM-CSF, or recombinant red blood cell generators).
• Patients with bilateral hydronephrosis that cannot be alleviated by ureteral stent or percutaneous renal fistula formation.

Sponsors & Collaborators

• Yonsei University: lead
• Genexine, Inc.: collaborator
• NeoImmuneTech: collaborator

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

efineptakin alfa; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Hye Ryun Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 18, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)