CompletedPhase 1/2

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

South Korea65 participantsStarted 2018-06-19

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Patients must be female and age ≥ 18 years (19 years for Korean sites)
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
✓. Life Expectancy of at least 6 months
✓. 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

✕. Patient has disease that is suitable for local therapy administered with curative intent.
✕. Patient has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
✕. 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.
✕. Patient has a history of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
✕. 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)
✕. 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.
✕. Patients has had an allogeneic solid organ or allogeneic bone marrow transplant

What they're measuring

DLT Evaluation for Safety and Tolerability(Part A)

Timeframe: within 21days

ORR for Efficacy (Part B&C)

Timeframe: within 24 weeks

Trial details

NCT IDNCT03444376

SponsorGenexine, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-29

Results submitted2025-04-25

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