Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697576
Status:
RECRUITING
Last Update Posted:
2023-07-18
First Post:
2021-01-05
Brief Title:
Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma
Sponsor:
Carlo Contreras
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Intralesional Influenza Vaccine for Patients with Melanoma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial investigates the effects of influenza vaccine in treating patients with stage I-IV melanoma While intramuscular administration of influenza vaccine provides immunization against the influenza virus giving influenza vaccine directly into the tumor intralesional may decrease the size of the injected melanoma tumor or the extent of the melanoma within the body
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the safety and tolerability and determine the maximum tolerated dose of intralesional quadrivalent inactivated influenza vaccine unadjuvanted influenza vaccine for patients with a resectable melanoma as monotherapy and b metastatic melanoma concurrent with standard of care single- or dual-agent checkpoint inhibition
SECONDARY OBJECTIVES
I To evaluate tumor dimensions of injected Cohorts 1-2 and non-injected lesions Cohort 2 only by caliper or ultrasound measurement Clinical endpoint II To determine time to disease progression local or distant Clinical endpoint III To evaluate immunohistochemistry density cellsmm2 CD4 CD8 PD-L1 PD1 CD56 CD20 CD45RO FOXP3 Tumor-based endpoint IV To evaluate granzyme B H-score Tumor-based endpoint V To evaluate NanoString Pan Cancer Immune Profiling Panel Tumor-based endpoint VI To evaluate tumor-infiltrating lymphocytes not identified present non-brisk present brisk cannot be determined Tumor-based endpoint VII To evaluate degree of tumor regression percent Tumor-based endpoint VIII To evaluate changes in micro ribonucleic acid microRNA expression Tumor-based endpoint IX To evaluate of flow cytometry for T-cell subset evaluation and changes in circulating microRNA Blood draw endpoint
EXPLORATORY OBJECTIVE
I To evaluate the evidence of immunologic activation in blood and tissue specimens
OUTLINE This is dose-escalation study Patients are assigned to 1 of 2 cohorts
COHORT I Patients receive quadrivalent inactivated influenza vaccine intramuscularly IM on day 0 and intratumorally on days 2 and 14 in the absence of disease progression or unacceptable toxicity Patients then undergo surgery on day 28
COHORT II Patients receive quadrivalent inactivated influenza vaccine IM on day 0 and intratumorally on days 2 14 28 42 56 70 84 and 98 in the absence of disease progression or unacceptable toxicity Patients also receive standard of care ipilimumab nivolumab pembrolizumab or Opdualag
After completion of study treatment patients are followed up for up to 1 year
I To evaluate the safety and tolerability and determine the maximum tolerated dose of intralesional quadrivalent inactivated influenza vaccine unadjuvanted influenza vaccine for patients with a resectable melanoma as monotherapy and b metastatic melanoma concurrent with standard of care single- or dual-agent checkpoint inhibition
SECONDARY OBJECTIVES
I To evaluate tumor dimensions of injected Cohorts 1-2 and non-injected lesions Cohort 2 only by caliper or ultrasound measurement Clinical endpoint II To determine time to disease progression local or distant Clinical endpoint III To evaluate immunohistochemistry density cellsmm2 CD4 CD8 PD-L1 PD1 CD56 CD20 CD45RO FOXP3 Tumor-based endpoint IV To evaluate granzyme B H-score Tumor-based endpoint V To evaluate NanoString Pan Cancer Immune Profiling Panel Tumor-based endpoint VI To evaluate tumor-infiltrating lymphocytes not identified present non-brisk present brisk cannot be determined Tumor-based endpoint VII To evaluate degree of tumor regression percent Tumor-based endpoint VIII To evaluate changes in micro ribonucleic acid microRNA expression Tumor-based endpoint IX To evaluate of flow cytometry for T-cell subset evaluation and changes in circulating microRNA Blood draw endpoint
EXPLORATORY OBJECTIVE
I To evaluate the evidence of immunologic activation in blood and tissue specimens
OUTLINE This is dose-escalation study Patients are assigned to 1 of 2 cohorts
COHORT I Patients receive quadrivalent inactivated influenza vaccine intramuscularly IM on day 0 and intratumorally on days 2 and 14 in the absence of disease progression or unacceptable toxicity Patients then undergo surgery on day 28
COHORT II Patients receive quadrivalent inactivated influenza vaccine IM on day 0 and intratumorally on days 2 14 28 42 56 70 84 and 98 in the absence of disease progression or unacceptable toxicity Patients also receive standard of care ipilimumab nivolumab pembrolizumab or Opdualag
After completion of study treatment patients are followed up for up to 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-13282 | REGISTRY | CTRP Clinical Trial Reporting Program | None |