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

Sponsor
Yonsei University
Study ID
NCT05280457
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Apr 15, 2022
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nivolumab-GX-188E-GX-I7

Primary Outcome Measure

Objective Response Rate(ORR) [ Time Frame: documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

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