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Cervical CancerPhase 1/2NCT03444376

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

A Phase 1/2 study testing GX-188E and KEYTRUDA® in people with Cervical Cancer, run by Genexine, Inc. at 9 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
GX-188E and KEYTRUDA®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
9 sitesSouth Korea
Study dates
19 Jun 2018to 21 Dec 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Inje University Busan Paik Hospital

    Busan

  • Keimyung University Dongsan Medical Center

    Daegu, 42601

  • National Cancer Center

    Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

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

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 152-703

Other trials in South Korea

About this study

Official title: 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

Read the 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.

Conditions
Cervical Cancer
Being tested
GX-188E, KEYTRUDA®
Keywords
KEYTRUDA®, pembrolizumab, GX-188E, TDS-IM device, KEYNOTE-567
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GX-188EDrug

    Also called tirvalimogene teraplasmid

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

  • KEYTRUDA®Drug

    Also called pembrolizumab

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

Study groups in NCT03444376
Study groupRoleWhat they receive
GX-188E, KEYTRUDA®ExperimentalGX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
Receives: Drug: GX-188E; Drug: KEYTRUDA®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT Evaluation for Safety and Tolerability(Part A)

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

    Measured: within 21days

  2. ORR for Efficacy (Part B&C)

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

    Measured: within 24 weeks

Secondary outcomes (6)

  1. ORR for Efficacy (Part A)

    Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC)

    Measured: within 24 weeks

  2. BORR (Part B&C)

    Best Overall Response Rate(BORR) by RECIST v1.1

    Measured: up to 1 year

  3. Time-to-Best Response

    Time-to-Best Response by RECIST v1.1 and iRECIST

    Measured: up to 1 year

  4. Duration of Response (DOR)

    Duration of Response (DOR) by RECIST v1.1 and iRECIST

    Measured: up to 1 year

  5. Progression-Free Survival (PFS)

    6month- PFS by RECIST v1.1 and iRECIST

    Measured: up to 6 months

  6. Overall Survival (OS)

    Overall Survival (OS) by RECIST v1.1 and iRECIST

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2018
  2. Study start19 Jun 2018
  3. Primary completion29 Apr 2022
  4. Study completion21 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03444376
Sponsor's protocol ID
GX-188E-005
Other IDs
MK-3475-567, KEYNOTE-567
Status last verified
Jul 2025
First submitted
25 Jan 2018
Last updated
30 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39823099

  • 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.

    PubMed 33271094

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GX-188E and KEYTRUDA® in people with Cervical Cancer, run by Genexine, Inc. at 9 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT Evaluation for Safety and Tolerability(Part A) (time frame: within 21days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03444376, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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