Clincosm LogoSign in Get a demo

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

Sponsor
Genexine, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03444376
Collaborator
Merck Sharp & Dohme LLC (Industry)
60
Enrollment
8
Locations
1
Arm
67.3
Anticipated Duration (Months)
7.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 23, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: GX-188E, Keytruda

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

Drug: GX-188E
GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
Other Names:
  • Ichor Tri-Grid Delivery System

    • Drug: Keytruda
    pembrolizumab(100mg/4mL/vial), Intravenous administration
    Other Names:
  • Pembrolizumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. DLT evaluation for safety and tolerability(part A) [within 21days]

      Patient will be evaluated for the first 21 days for dose-limiting toxicities.

    2. ORR for efficacy(part B&C) [within 24 weeks]

      ORR within 24 weeks (ORR24) evaluated by RECIST v1.1

    Secondary Outcome Measures

    1. 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)

    2. BORR (part B&C) [up to 1 year]

      Best Overall Response Rate(BORR24) by RECIST v1.1

    3. Time-to-Best Response [up to 1 year]

      Time-to-Best Response by RECIST v1.1 and iRECIST

    4. Duration of Response (DOR) [up to 1 year]

      Duration of Response (DOR) by RECIST v1.1 and iRECIST

    5. Progression-Free Survival (PFS) [up to 6 months]

      6month- PFS by RECIST v1.1 and iRECIST

    6. Overall Survival (OS) [up to 1 year]

      Overall Survival (OS) by RECIST v1.1 and iRECIST

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 42601
    2 National Cancer Center Gyeonggi-do Korea, Republic of 10408
    3 Seoul National University Bundang Hospital Gyeonggi-do Korea, Republic of 13620
    4 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    5 Asan Medical Center Seoul Korea, Republic of 05505
    6 Samsung Medical Center Seoul Korea, Republic of 06351
    7 The Catholic University of Korea Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    8 Korea University Guro Hospital Seoul Korea, Republic of 152-703

    Sponsors and Collaborators

    • Genexine, Inc.
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Soo-Young Hur, M.D, The Catholic University of Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genexine, Inc.
    ClinicalTrials.gov Identifier:
    NCT03444376
    Other Study ID Numbers:
    • GX-188E-005
    First Posted:
    Feb 23, 2018
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Genexine, Inc.
    keytruda
    pembrolizumab
    GX-188E
    TDS-IM device
    KEYNOTE-567
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Pembrolizumab

    Study Results

    No Results Posted as of Apr 6, 2022