The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer
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ClinicalTrials.gov Identifier: NCT03444376 |
Recruitment Status :
Completed
First Posted : February 23, 2018
Last Update Posted : March 1, 2024
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Condition or disease | Intervention/treatment | Phase |
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Cervical Cancer | Drug: GX-188E Drug: KEYTRUDA® | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 19, 2018 |
Actual Primary Completion Date : | April 29, 2022 |
Actual Study Completion Date : | December 21, 2023 |
Arm | Intervention/treatment |
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Experimental: GX-188E, KEYTRUDA®
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
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Drug: GX-188E
GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
Other Name: Ichor Tri-Grid Delivery System Drug: KEYTRUDA® pembrolizumab(100mg/4mL/vial), Intravenous administration
Other Name: pembrolizumab |
- 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.
- ORR for efficacy(part B&C) [ Time Frame: within 24 weeks ]ORR within 24 weeks (ORR24) evaluated by RECIST v1.1
- ORR for efficacy(part A) [ Time Frame: up to 1 year ]Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC)
- BORR (part B&C) [ Time Frame: up to 1 year ]Best Overall Response Rate(BORR24) by RECIST v1.1
- Time-to-Best Response [ Time Frame: up to 1 year ]Time-to-Best Response by RECIST v1.1 and iRECIST
- Duration of Response (DOR) [ Time Frame: up to 1 year ]Duration of Response (DOR) by RECIST v1.1 and iRECIST
- Progression-Free Survival (PFS) [ Time Frame: up to 6 months ]6month- PFS by RECIST v1.1 and iRECIST
- Overall Survival (OS) [ Time Frame: up to 1 year ]Overall Survival (OS) by RECIST v1.1 and iRECIST
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444376
Korea, Republic of | |
Inje University Busan Paik Hospital | |
Busan, Korea, Republic of | |
Keimyung University Dongsan Medical Center | |
Daegu, Korea, Republic of, 42601 | |
National Cancer Center | |
Gyeonggi-do, Korea, Republic of, 10408 | |
Seoul National University Bundang Hospital | |
Gyeonggi-do, Korea, Republic of, 13620 | |
Severance Hospital, Yonsei University Health System | |
Seoul, Korea, Republic of, 03722 | |
Asan Medical Center | |
Seoul, Korea, Republic of, 05505 | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 06351 | |
The Catholic University of Korea Seoul St. Mary's Hospital | |
Seoul, Korea, Republic of, 06591 | |
Korea University Guro Hospital | |
Seoul, Korea, Republic of, 152-703 |
Principal Investigator: | Soo-Young Hur, M.D | The Catholic University of Korea |
Responsible Party: | Genexine, Inc. |
ClinicalTrials.gov Identifier: | NCT03444376 |
Other Study ID Numbers: |
GX-188E-005 MK-3475-567 ( Other Identifier: Merck Sharp & Dohme LLC ) KEYNOTE-567 ( Other Identifier: Merck Sharp & Dohme LLC ) |
First Posted: | February 23, 2018 Key Record Dates |
Last Update Posted: | March 1, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
KEYTRUDA® pembrolizumab GX-188E TDS-IM device KEYNOTE-567 |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |