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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03444376
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : August 20, 2018
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Genexine, Inc.

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
Cervical Cancer Drug: GX-188E Drug: Keytruda 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
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
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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 Ichor TDS-IM device
Other Names:
  • Therapeutic DNA vaccine
  • Ichor Tri-Grid Delivery System

Drug: Keytruda
pembrolizumab(100mg/4mL/vial), Intravenous administration

Primary Outcome Measures :
  1. DLT evaluation for safety and tolerability(part A) [ Time Frame: within 21days ]
    Patient will be evaluated for the first 21 days for dose-limiting toxicities.

  2. ORR for efficacy(part B) [ Time Frame: within 24 weeks ]
    ORR within 24 weeks (ORR24) evaluated by RECIST v1.1

Secondary Outcome Measures :
  1. ORR for efficacy(part A) [ Time Frame: up to 1 year ]
    Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC)

  2. BORR [ Time Frame: up to 1 year ]
    Best Overall Response Rate(BORR24) by RECIST v1.1 and irRC

  3. Time-to-Best Response [ Time Frame: up to 1 year ]
  4. Duration of Response (DOR) [ Time Frame: up to 1 year ]
  5. Progression-Free Survival (PFS) [ Time Frame: up to 6 months ]
    6month- PFS

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03444376

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Contact: Younyoung Hwang +82-31-628-3271

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Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Hae Hee-sook, CRC    +82-2-2258-2724   
Principal Investigator: Park Jong-Sup, M.D.         
Sub-Investigator: Hur Soo-Young, M.D.         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Contact: Lee Hye-Lim, CRC    +82-2-2626-1206   
Principal Investigator: Lee Jae-Kwan, M.D.         
Sponsors and Collaborators
Genexine, Inc.
Merck Sharp & Dohme Corp.
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Principal Investigator: Jong-Sup Park, M.D The Catholic University of Korea

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Responsible Party: Genexine, Inc. Identifier: NCT03444376     History of Changes
Other Study ID Numbers: GX-188E-005
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genexine, Inc.:
TDS-IM device
Additional relevant MeSH terms:
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Uterine Cervical Diseases
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents, Immunological
Antineoplastic Agents