NCT03444376

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2018

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3.9 years

First QC Date

January 25, 2018

Results QC Date

April 25, 2025

Last Update Submit

July 10, 2025

Conditions

Cervical Cancer

Keywords

KEYTRUDA®pembrolizumabGX-188ETDS-IM deviceKEYNOTE-567

Outcome Measures

Primary Outcomes (2)

  • DLT Evaluation for Safety and Tolerability(Part A)

    Patient will be evaluated for the first 21 days for dose-limiting toxicities.

    within 21days

  • ORR for Efficacy (Part B&C)

    ORR within 24 weeks (ORR24) evaluated by RECIST v1.1

    within 24 weeks

Secondary Outcomes (6)

  • ORR for Efficacy (Part A)

    within 24 weeks

  • BORR (Part B&C)

    up to 1 year

  • Time-to-Best Response

    up to 1 year

  • Duration of Response (DOR)

    up to 1 year

  • Progression-Free Survival (PFS)

    up to 6 months

  • +1 more secondary outcomes

Study Arms (1)

GX-188E, KEYTRUDA®

EXPERIMENTAL

GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg

Drug: GX-188EDrug: KEYTRUDA®

Interventions

GX-188EDRUG

GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device

Also known as: tirvalimogene teraplasmid
GX-188E, KEYTRUDA®
KEYTRUDA®DRUG

pembrolizumab(100mg/4mL/vial), Intravenous administration

Also known as: pembrolizumab
GX-188E, KEYTRUDA®

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be female and age ≥ 18 years (19 years for Korean sites)
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Life Expectancy of at least 6 months
  • 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.

You may not qualify if:

  • Patient has disease that is suitable for local therapy administered with curative intent.
  • Patient has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • 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.
  • Patient has a history of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • 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)
  • 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.
  • Patients has had an allogeneic solid organ or allogeneic bone marrow transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Inje University Busan Paik Hospital

Busan, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Related Publications (2)

  • Lim MC, Choi YJ, Hur SY, Kim YM, No JH, Kim BG, Cho CH, Kim SH, Jeong DH, Lee JK, Kim JH, Choi YJ, Woo JW, Sung YC, Park JS. GX-188E DNA vaccine plus pembrolizumab in HPV 16- and/or 18-positive recurrent or advance cervical cancer: a phase 2 trial. EClinicalMedicine. 2024 Jul 13;74:102716. doi: 10.1016/j.eclinm.2024.102716. eCollection 2024 Aug.

    PMID: 39823099DERIVED

  • Youn JW, Hur SY, Woo JW, Kim YM, Lim MC, Park SY, Seo SS, No JH, Kim BG, Lee JK, Shin SJ, Kim K, Chaney MF, Choi YJ, Suh YS, Park JS, Sung YC. Pembrolizumab plus GX-188E therapeutic DNA vaccine in patients with HPV-16-positive or HPV-18-positive advanced cervical cancer: interim results of a single-arm, phase 2 trial. Lancet Oncol. 2020 Dec;21(12):1653-1660. doi: 10.1016/S1470-2045(20)30486-1.

    PMID: 33271094DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

GX-188 vaccinepembrolizumab

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
• Project Lead
Organization
Clinical Development
yoonjeong.choi@genexine.com
+82-2-6098-2756

Study Officials

  • Soo-Young Hur, M.D

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 23, 2018

Study Start

June 19, 2018

Primary Completion

April 29, 2022

Study Completion

December 21, 2023

Last Updated

July 30, 2025

Results First Posted

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(9)