The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer

July 10, 2025 updated by: Genexine, Inc.

A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients With Advanced, Non-Resectable HPV Type 16 and/or 18 Positive Cervical Cancer

A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label Phase Ib-II trial to evaluate the safety and efficacy of GX-188E (IM administration using Ichor TDS-IM device) + pembrolizumab (P) in patients with advanced HPV-16+ or HPV-18+ cervical cancer.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Inje University Busan Paik Hospital
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Medical Center
      • Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St. Mary'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients must be female and age ≥ 18 years (19 years for Korean sites)
  2. Patients with histologically confirmed advanced or metastatic HPV-positive (HPV-16 or HPV-18) cervical cancer, who have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  4. Life Expectancy of at least 6 months
  5. Patients must agree to provide either an archival tumor tissue sample or fresh biopsy sample for baseline biomarker tissue analyses, including staining for PD-L1. If archival tissue is not available and the patient does not have biopsy-accessible tumor lesions, the patient will be excluded.

Exclusion Criteria:

  1. Patient has disease that is suitable for local therapy administered with curative intent.
  2. Patient has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  3. Patient is expected to require any other form of antineoplastic therapy while on study; including systemic chemotherapy, radiation therapy (except for palliative purposes) biological therapy, or immunotherapy not specified in this protocol.
  4. Patient has a history of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  5. Patients have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE)
  6. Patients with active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  7. Patients has had an allogeneic solid organ or allogeneic bone marrow transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GX-188E, KEYTRUDA®
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
Drug: GX-188E
GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
Other Names:
  • tirvalimogene teraplasmid
Drug: KEYTRUDA®
pembrolizumab(100mg/4mL/vial), Intravenous administration
Other Names:
  • pembrolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT Evaluation for Safety and Tolerability(Part A)
Time Frame: within 21days
Patient will be evaluated for the first 21 days for dose-limiting toxicities.
within 21days
ORR for Efficacy (Part B&C)
Time Frame: within 24 weeks
ORR within 24 weeks (ORR24) evaluated by RECIST v1.1
within 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-Best Response
Time Frame: up to 1 year
Time-to-Best Response by RECIST v1.1 and iRECIST
up to 1 year
Duration of Response (DOR)
Time Frame: up to 1 year
Duration of Response (DOR) by RECIST v1.1 and iRECIST
up to 1 year
Progression-Free Survival (PFS)
Time Frame: up to 6 months
6month- PFS by RECIST v1.1 and iRECIST
up to 6 months
Overall Survival (OS)
Time Frame: up to 1 year
Overall Survival (OS) by RECIST v1.1 and iRECIST
up to 1 year
ORR for Efficacy (Part A)
Time Frame: within 24 weeks
Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC)
within 24 weeks
BORR (Part B&C)
Time Frame: up to 1 year
Best Overall Response Rate(BORR) by RECIST v1.1
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genexine, Inc.

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Soo-Young Hur, M.D, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Actual)

April 29, 2022

Study Completion (Actual)

December 21, 2023

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX-188E-005
  • MK-3475-567 (Other Identifier: Merck Sharp & Dohme LLC)
  • KEYNOTE-567 (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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