Description:
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
Title
- Brief Title: the Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Cervical Cancer
- 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
Clinical Trial IDs
- ORG STUDY ID:
GX-188E-005
- NCT ID:
NCT03444376
Conditions
Interventions
Drug | Synonyms | Arms |
---|
GX-188E | Therapeutic DNA vaccine, Ichor Tri-Grid Delivery System | GX-188E, Keytruda |
Keytruda | | GX-188E, Keytruda |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
GX-188E, Keytruda | Experimental | GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg Keytruda:Day 1 q3 weeks/ 200mg | |
Eligibility Criteria
Inclusion Criteria:
1. Patients must be female and age ≥ 18 years (19 years for Korean sites)
2. Patients with histologically confirmed diagnosis of advanced, inoperable or metastatic
cervical cancer who is positive for HPV-16 or HPV-18 AND failed (or not eligible to)
standard-of-care chemotherapy and/or radiation.
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:
1. Patient has disease that is suitable for local therapy administered with curative
intent.
2. Any other current or previous malignancy within the past three years that, in the
opinion of the Principal Investigator will interfere with study-specific endpoints.
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 if the patient has previously participated in Merck MK-3475 clinical trials.
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 to be an excluded systemic treatment and will be permitted. Patients
whose autoimmune disease is well-controlled and who require ongoing systemic therapy
that is not immunosuppressive in nature (e.g. patients with Grave's disease post
thyroid ablation receiving levothyroxine) are eligible.
7. Patients with a history of either solid organ or hematopoietic stem cell
transplantation(HSCT)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | DLT evaluation for safety and tolerability(part A) |
Time Frame: | within 21days |
Safety Issue: | |
Description: | Patient will be evaluated for the first 21 days for dose-limiting toxicities. |
Secondary Outcome Measures
Measure: | ORR for efficacy(part A) |
Time Frame: | up to 1 year |
Safety Issue: | |
Description: | Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC) |
Measure: | BORR |
Time Frame: | up to 1 year |
Safety Issue: | |
Description: | Best Overall Response Rate(BORR24) by RECIST v1.1 and irRC |
Measure: | Time-to-Best Response |
Time Frame: | up to 1 year |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) |
Time Frame: | up to 1 year |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | up to 6 months |
Safety Issue: | |
Description: | 6month- PFS |
Measure: | Overall Survival (OS) |
Time Frame: | up to 1 year |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Genexine, Inc. |
Trial Keywords
- keytruda
- pembrolizumab
- GX-188E
- TDS-IM device
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