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

NCT05280457 | Active Not Recruiting Phase 2

• 1 other identifier: 4-2022-0030
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC; triple combination therapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  ORR will be evaluated according to RECIST v1.1 after IP administration and Response data will be used for the primary endpoint.

  documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (7)

• Best Overall Response Rate(BORR)

  documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• Time to Best Overall Response

  documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• Duration of response

  Up to 2 years

• median progression-free survival

  Up to 2 years

• progression-free survival

  Up to 2 years

Study Arms (1)

nivolumab-GX-188E-GX-I7

EXPERIMENTAL

Drug: nivolumab-GX-188E-GX-I7

Interventions

nivolumab-GX-188E-GX-I7 DRUG

* Nivolumab 3 mg/kg IV administered every 2 weeks * GX-188E 2 mg IM at Weeks 1, 2, 4, 7, 10, 13, and 19 * GX-I7 1200 μg/kg or the recommended dose of the introductory safety cohort is administered at weeks 2, 10, and 18

nivolumab-GX-188E-GX-I7

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Histologically confirmed, advanced or metastatic, HPV-positive (positive on p16 immunohistochemistry and positive on HPV-16 or HPV-18 nucleic acid test) R/M HNSCC patients
• Patients with disease progression after platinum-based chemotherapy are eligible for participation.
• Patients with recurrence within 6 months after conventional platinum-based chemotherapy are considered platinum-based treatment failure.
• Patients who have received first-line or second-line chemotherapy are eligible to participate. That is, patients whose treatment in this trials is the second or third lince chemotherapy can be enrolled.
• PD-L1 (DAKO 28-8 TPS) ≥1%
• Eastern Cooperative Oncology Group (ECOG) Activity Status 0-1
• Patients with a life expectancy of at least 6 months
• Patients must agree to provide a storage tumor tissue sample or a fresh biopsy sample for baseline biomarker tissue analysis including PD-L1 staining. Patients without tissue for storage and without tumor lesions for which biopsies can be obtained will be excluded from the study.
• The patient must have adequate organ function as defined below. Specimens must be collected within 28 days prior to be administered the investigational drug.
• \[hematology\]
• Absolute neutrophil count (ANC) ≥1,500/μL
• Platelets ≥100,000/μL
• Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L1 \[kidney\]
• Creatinine or creatinine clearance measured or calculated2 (GFR may be used instead of creatinine or CrCl) ≤1.5 × ULN or, For subjects with creatinine \> 1.5x laboratory ULN, ≥30 mL/min \[liver\]

You may not qualify if:

• When the disease is suitable for topical therapy for the purpose of cure
• If it is confirmed that there is another malignant disease that is currently ongoing or required active treatment within the past 3 years.
• NOTE: Subjects with cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ (eg breast cancer) who have received potentially curative treatment are not excluded.
• Patients expected to require another antineoplastic treatment during the trial; This treatment includes systemic chemotherapy, radiotherapy (except palliative care), biological therapy, or immunotherapy not specified in the protocol.
• Patients with a history of active central nervous system (CNS) metastasis and/or carcinoma meningitis. Patients with asymptomatic or controlled CNS metastases may be eligible.
• Past treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that act directly on other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX40, CD137)
• Patients with active autoimmune disease requiring systemic immunosuppressive therapy (eg, use of disease modulators, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapy (e.g., replacement of thyroxine, insulin, or physiological corticosteroids due to adrenal or pituitary insufficiency) is allowed because it is not considered a form of systemic treatment.
• Patients who underwent allogeneic solid organ transplant or allogeneic bone marrow transplant
• Non-PD-1/PD-L1/PD-L2, anticancer monoclonal antibody (mAb) (eg, bevacizumab, cetuximab, etc.) has been administered within 4 weeks prior to the first administration of the investigational drug, or for more than 4 weeks Patients who have not yet recovered (eg, Grade 1 or lower or to baseline levels) from adverse events due to medications administered prior to a time point.
• Patients who received systemic chemotherapy including other investigational drugs within 4 weeks prior to the first administration of this study drug, or who received targeted small molecule therapy with a half-life of less than 48 hours within 2 weeks Note: Subjects must have had any adverse reactions caused by previous treatment to have returned to Grade 1 or less or baseline levels. Grade 2 neuropathy and/or grade 2 anemia may be appropriate.
• Note: If a subject has undergone major surgery, the subject must have adequately recovered from toxicity and/or complications from the intervention prior to initiation of treatment.
• Patients who have received radiation therapy within 2 weeks prior to starting the investigational drug. Subjects must have recovered from any radiation-related toxicity.
• Patients who have transfused blood products (including platelets or red blood cells) within 4 weeks prior to the first administration of the investigational drug or have received colony stimulating factors (including G-CSF, GM-CSF, or recombinant erythropoietin)
• Patients with bilateral hydronephrosis that cannot be relieved by ureteral stents or percutaneous renal fistuloplasty.
• Patients with severe (≥ Grade 3) hypersensitivity to nivolumab and/or one of its excipient components

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 15, 2022
• Study Start: April 15, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)