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The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced 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.
 
ClinicalTrials.gov Identifier: NCT03444376
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
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 : 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
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 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 electroporator, Ichor TDS-IM device
Other Name: Ichor Tri-Grid Delivery System

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




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&C) [ 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 (part B&C) [ Time Frame: up to 1 year ]
    Best Overall Response Rate(BORR24) by RECIST v1.1

  3. Time-to-Best Response [ Time Frame: up to 1 year ]
    Time-to-Best Response by RECIST v1.1 and iRECIST

  4. Duration of Response (DOR) [ Time Frame: up to 1 year ]
    Duration of Response (DOR) by RECIST v1.1 and iRECIST

  5. Progression-Free Survival (PFS) [ Time Frame: up to 6 months ]
    6month- PFS by RECIST v1.1 and iRECIST

  6. Overall Survival (OS) [ Time Frame: up to 1 year ]
    Overall Survival (OS) by RECIST v1.1 and iRECIST



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT03444376


Contacts
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Contact: Yoonjeong Choi +82-31-628-3233 yoonjeong.choi@genexine.com

Locations
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Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 42601
Contact: U-Eun Choi    +82-53-258-6678    ueun_@naver.com   
Principal Investigator: Chi Heum Cho, M.D         
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Contact: Ae jeong Choi    +82-31-920-0852    75334@ncc.re.kr   
Principal Investigator: Myong Cheol Lim, M.D         
Seoul National University Bundang Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 13620
Contact: HyunHee Lee    +82-31-787-8306    leehhni@gmail.com   
Principal Investigator: Jae Hong No, M.D         
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: SuYeon Kim    +82-2-2228-0570    SUE63@yuhs.ac   
Principal Investigator: Sunghoon Kim, M.D         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: In-Jung Nam    +82-2-3010-8697    nij82@amc.seoul.kr   
Principal Investigator: Yong-Man Kim, M.D         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: MyungHee Nam       myunghee.nam@samsung.com   
Principal Investigator: Byoung-Gie Kim, M.D         
The Catholic University of Korea Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Ji Sun Roh, CRC    +82-2-2258-2738    jisun_8646@daum.net   
Principal Investigator: Soo-Young Hur, M.D.         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Contact: SeungJi Yang, CRC    +82-2-2626-1637    gig10002@nate.com   
Principal Investigator: Jae-Kwan Lee, M.D.         
Sponsors and Collaborators
Genexine, Inc.
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Soo-Young Hur, M.D The Catholic University of Korea
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT03444376    
Other Study ID Numbers: GX-188E-005
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
keytruda
pembrolizumab
GX-188E
TDS-IM device
KEYNOTE-567
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents