Actively Recruiting
HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy
Led by Yonsei University · Updated on 2026-02-09
21
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to explore the efficacy and safety of GX-188E DNA vaccination, GX-I7, and nivolumab combination therapy in HPV 16-positive and/or HPV-18 positive R/M HNSCC patients. The objective of this study is as follows. * Primary objective: Objective response rate (ORR) according to RECIST v1.1 * Secondary objectives: disease control rate (DCR) according to RECIST v1.1, progression-free survival (PFS) at 6 months, median progression-free survival (PFS), median overall survival (OS), biomarker correlation, safety and tolerability.
CONDITIONS
Official Title
HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 19 years of age or older
- Histologically confirmed advanced or metastatic HPV-positive recurrent or metastatic head and neck squamous cell carcinoma
- HPV positivity confirmed by p16 immunohistochemistry and HPV-16 or HPV-18 nucleic acid test
- Disease progression after platinum-based chemotherapy
- Patients who have received first-line or second-line chemotherapy
- PD-L1 expression of 1% or higher (DAKO 28-8 TPS)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 6 months
- Agreement to provide tumor tissue or fresh biopsy for biomarker analysis
- Adequate organ function based on blood counts, kidney, liver, and coagulation parameters
- Measurable disease by RECIST with tumor lesions or lymph nodes meeting size criteria
- Negative pregnancy test for women of childbearing potential
- Women of childbearing potential agree to use double contraception during the study and for 120 days after
- Willingness to provide written informed consent
You will not qualify if you...
- Disease suitable for curative topical therapy
- Presence of another active malignant disease needing treatment within past 3 years (except certain skin cancers and carcinoma in situ)
- Need for other antineoplastic treatments during trial (except palliative radiotherapy)
- History of active central nervous system metastases or carcinoma meningitis (controlled or asymptomatic CNS metastases allowed)
- Prior treatment with anti-PD-1/PD-L1/PD-L2 or similar immunotherapies
- Active autoimmune disease requiring systemic immunosuppressive therapy within past 2 years
- History of allogeneic solid organ or bone marrow transplant
- Recent administration of certain monoclonal antibodies or chemotherapy within specified timeframes
- Recent radiation therapy within 2 weeks
- Recent blood transfusion or colony stimulating factors
- Unrelieved bilateral hydronephrosis
- Severe hypersensitivity to nivolumab or its components
- History or current interstitial pneumonia requiring steroids
- Immunodeficiency or recent systemic steroid/immunosuppressive treatment
- Risk factors for intestinal obstruction or perforation
- Participation in other clinical trials with investigational drugs within 4 weeks
- Unstable or improper heart function including recent myocardial infarction or severe heart failure
- Active infection requiring systemic treatment
- Confirmed HIV infection or active hepatitis B or C
- History of active tuberculosis
- Recent live vaccinations within 30 days
- Mental illness or substance abuse interfering with trial participation
- Presence of implanted electronic devices
- Positive pregnancy test or pregnancy/lactation
- Conditions or treatments likely to interfere with trial results or participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hye Ryun Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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