The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer
- Registration Number
- NCT03444376
- Lead Sponsor
- Genexine, Inc.
- 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+ cervical cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 65
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GX-188E, KEYTRUDA® KEYTRUDA® GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg GX-188E, KEYTRUDA® GX-188E GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
- Primary Outcome Measures
Name Time Method DLT evaluation for safety and tolerability(part A) within 21days Patient will be evaluated for the first 21 days for dose-limiting toxicities.
ORR for efficacy(part B&C) within 24 weeks ORR within 24 weeks (ORR24) evaluated by RECIST v1.1
- Secondary Outcome Measures
Name Time Method BORR (part B&C) up to 1 year Best Overall Response Rate(BORR24) by RECIST v1.1
Time-to-Best Response up to 1 year Time-to-Best Response by RECIST v1.1 and iRECIST
Duration of Response (DOR) up to 1 year Duration of Response (DOR) by RECIST v1.1 and iRECIST
Overall Survival (OS) up to 1 year Overall Survival (OS) by RECIST v1.1 and iRECIST
ORR for efficacy(part A) up to 1 year Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC)
Progression-Free Survival (PFS) up to 6 months 6month- PFS by RECIST v1.1 and iRECIST
Trial Locations
- Locations (9)
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
National Cancer Center
🇰🇷Gyeonggi-do, Korea, Republic of