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

Cervical Cancer Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT03444376
• Other study ID #: GX-188E-005
• Secondary ID: MK-3475-567KEYNO
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 19, 2018
• Est. completion date: December 21, 2023

Study information

• Verified date: February 2024
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 21, 2023
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• GX-188E
GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
• KEYTRUDA®
pembrolizumab(100mg/4mL/vial), Intravenous administration

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Genexine, Inc.	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT evaluation for safety and tolerability(part A)	Patient will be evaluated for the first 21 days for dose-limiting toxicities.	within 21days
Primary	ORR for efficacy(part B&C)	ORR within 24 weeks (ORR24) evaluated by RECIST v1.1	within 24 weeks
Secondary	ORR for efficacy(part A)	Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC)	up to 1 year
Secondary	BORR (part B&C)	Best Overall Response Rate(BORR24) by RECIST v1.1	up to 1 year
Secondary	Time-to-Best Response	Time-to-Best Response by RECIST v1.1 and iRECIST	up to 1 year
Secondary	Duration of Response (DOR)	Duration of Response (DOR) by RECIST v1.1 and iRECIST	up to 1 year
Secondary	Progression-Free Survival (PFS)	6month- PFS by RECIST v1.1 and iRECIST	up to 6 months
Secondary	Overall Survival (OS)	Overall Survival (OS) by RECIST v1.1 and iRECIST	up to 1 year