OncoMatch/Clinical Trials/NCT05280457
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
Is NCT05280457 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies nivolumab-GX-188E-GX-I7 for head and neck squamous cell carcinoma.
Treatment: nivolumab-GX-188E-GX-I7 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV16 positive nucleic acid test
positive on HPV-16 or HPV-18 nucleic acid test
Required: HPV18 positive nucleic acid test
positive on HPV-16 or HPV-18 nucleic acid test
Required: CDKN2A overexpression
positive on p16 immunohistochemistry
Required: PD-L1 (CD274) overexpression (DAKO 28-8 TPS ≥1%)
PD-L1 (DAKO 28-8 TPS) ≥1%
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Patients with disease progression after platinum-based chemotherapy are eligible for participation.
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
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)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1,500/μL; Platelets ≥100,000/μL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Kidney function
Creatinine or creatinine clearance measured or calculated (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 function
Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN for subjects with total bilirubin concentration >1.5 × ULN (except for subjects with Gilbert syndrome, total bilirubin <3xULN and ALT <3xULN); AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN, for subjects with liver metastases)
The patient must have adequate organ function as defined below. ... [hematology] ANC ≥1,500/μL; Platelets ≥100,000/μL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L ... [kidney] Creatinine or creatinine clearance ... ≤1.5 × ULN or ... ≥30 mL/min ... [liver] Total bilirubin ≤1.5 × ULN ... AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN, for subjects with liver metastases)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify