Clinical Trials /

the Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ 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+ 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-188ETherapeutic DNA vaccine, Ichor Tri-Grid Delivery SystemGX-188E, Keytruda
KeytrudaGX-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 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

Last Updated

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