Overview

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

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
Female
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genexine, Inc.
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Pembrolizumab
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