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+ Advanced 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 | Ichor Tri-Grid Delivery System | GX-188E, Keytruda |
Keytruda | Pembrolizumab | 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 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:
1. Patient has disease that is suitable for local therapy administered with curative
intent.
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
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 (part B&C) |
Time Frame: | up to 1 year |
Safety Issue: | |
Description: | Best Overall Response Rate(BORR24) by RECIST v1.1 |
Measure: | Time-to-Best Response |
Time Frame: | up to 1 year |
Safety Issue: | |
Description: | Time-to-Best Response by RECIST v1.1 and iRECIST |
Measure: | Duration of Response (DOR) |
Time Frame: | up to 1 year |
Safety Issue: | |
Description: | Duration of Response (DOR) by RECIST v1.1 and iRECIST |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | up to 6 months |
Safety Issue: | |
Description: | 6month- PFS by RECIST v1.1 and iRECIST |
Measure: | Overall Survival (OS) |
Time Frame: | up to 1 year |
Safety Issue: | |
Description: | Overall Survival (OS) by RECIST v1.1 and iRECIST |
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
- KEYNOTE-567
Last Updated
August 4, 2020