Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-30 @ 9:39 PM
Study NCT ID:
NCT05280457
Status:
RECRUITING
Last Update Posted:
2023-03-28
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Yonsei University
Organization:
Study Overview
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 Open-label Phase 2 Clinical Trial With Lead-In Safety Cohort
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRINITY
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.
* 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.
Detailed Description:
The lead-in safety cohort enrolled 3 to 12 subjects, we will explore to occur the dose-limiting toxicity of pre-specified triple combination therapy (nivolumab 3 mg/kg IV + GX-188E 2 mg IM + GX-I7 1200 μg/kg). The lead-in safety cohort begins with a first 3 enrollment and is performed as a 3+3 design. The lead-in safety cohort will be enrolled the first 3 subjects and If none of the patients experience a DLT, it will be initiated a subsequent expansion cohort as that dose of lead-in safety cohort(nivolumab 3 mg/kg IV, GX-188E 2 mg IM, GX-I7 1200 μg/kg). If one out of three subjects initially enrolled in the lead-in safety cohort experiences DLT, three additional subjects will be enrolled to define the recommended dose. If more than 2 of the 6 additionally registered subjects experience DLT, a weight loss cohort will be initiated based on the pre-specified GX-I7 weight loss level (1200 μg/kg → 960 μg/kg). If not, administer the first dose of triple combination therapy (nivolumab 3 mg/kg IV, GX-188E 2 mg IM, GX-I7 1200 μg/kg) to a subsequent expansion cohort. If at least 2 out of 3 subjects initially enrolled in the introduction safety cohort experience DLT, the weight loss cohort will be initiated based on the pre-specified GX-I7 weight loss level (1200 μg/kg → 960 μg/kg). Evaluate the adequacy of GX-I7 weight loss based on the 3+3 design for the GX-I7 weight loss (960 μg/kg) cohort. The recommended GX-I7 dose (1200 μg/kg or 960 μg/kg) was confirmed from the weight loss cohort. After completion, additional subjects are enrolled in the subsequent expansion cohort to ensure that the total number of subjects in the entire cohort (introduction safety cohort and subsequent expansion cohort) is 21. If the recommended dose of .GX-I7 is not confirmed, the study should be redesigned.
In this study, the test drug is administered according to the following procedure.
* 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 Investigational therapy is continued until disease progression according to RECIST v1.1 or unacceptable toxicity according to CTCAE 5.0.
In this study, the test drug is administered according to the following procedure.
* 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 Investigational therapy is continued until disease progression according to RECIST v1.1 or unacceptable toxicity according to CTCAE 5.0.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: