Status:
COMPLETED
The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer
Lead Sponsor:
Genexine, Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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
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+ ce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03444376
Start Date
June 19 2018
End Date
December 21 2023
Last Update
July 30 2025
Active Locations (9)
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1
Inje University Busan Paik Hospital
Busan, South Korea
2
Keimyung University Dongsan Medical Center
Daegu, South Korea, 42601
3
National Cancer Center
Gyeonggi-do, South Korea, 10408
4
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea, 13620