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Trials / Recruiting

RecruitingNCT04697576

Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma

Intralesional Influenza Vaccine for Patients With Melanoma

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
36 (estimated)
Sponsor
Carlo Contreras · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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, cells/mm\^2: 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALIpilimumabimmune checkpoint inhibitor
BIOLOGICALNivolumabimmune checkpoint inhibitor
BIOLOGICALPembrolizumabimmune checkpoint inhibitor
BIOLOGICALQuadrivalent Inactivated Influenza VaccineGiven IM and intratumorally. For this protocol the U.S. F.D.A recently approved the use of recently expired influenza vaccine (only until new seasonal vaccine is available anticipated Sept 1). Use of expired vaccine will not exceed 4 months past June 30th expiry date (October 30th).
PROCEDUREResectionUndergo surgical resection
BIOLOGICALNivolumab + Relatlimabimmune checkpoint inhibitor

Timeline

Start date
2021-10-20
Primary completion
2027-09-30
Completion
2027-12-31
First posted
2021-01-06
Last updated
2026-03-10

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04697576. Inclusion in this directory is not an endorsement.