Clinical Trials /

The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer

NCT03444376

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

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

  • Cervical Cancer

Interventions

DrugSynonymsArms
GX-188EIchor Tri-Grid Delivery SystemGX-188E, Keytruda
KeytrudaPembrolizumabGX-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

NameTypeDescriptionInterventions
GX-188E, KeytrudaExperimentalGX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg Keytruda:Day 1 q3 weeks/ 200mg
  • GX-188E
  • Keytruda

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