The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer
NCT ID: NCT03444376
Last Updated: 2025-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
65 participants
INTERVENTIONAL
2018-06-19
2023-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GX-188E, KEYTRUDA®
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E
GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®
pembrolizumab(100mg/4mL/vial), Intravenous administration
Interventions
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GX-188E
GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®
pembrolizumab(100mg/4mL/vial), Intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Genexine, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Soo-Young Hur, M.D
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Locations
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Inje University Busan Paik Hospital
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
National Cancer Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MK-3475-567
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-567
Identifier Type: OTHER
Identifier Source: secondary_id
GX-188E-005
Identifier Type: -
Identifier Source: org_study_id
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