NCT06664151

A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is investigating the effects on immune cells of injecting the influenza vaccine (also known as "flu shot") into cutaneous squamous cell carcinoma (CSCC) tumors prior to having standard-of-care Mohs excision surgery. The study will help understand if the addition of the influenza vaccine could improve the immune system response against the cancer. The names of the study drug involved in this study is: -Fluzone Influenza vaccine (flu shot)

Detailed description

This Phase 0, window-of-opportunity study is investigating the effects on immune cells of injecting the influenza vaccine (also known as "flu shot") into cutaneous squamous cell carcinoma (CSCC) tumors prior to having standard-of-care Mohs excision surgery. This study will help understand if the addition of the influenza vaccine can improve the immune system response against the cancer. The research study procedures include screening for eligibility, in-clinic visits, blood tests, and measurements and photographs of tumors. It is expected that 25 people will take part in this research study.

Conditions

• Skin Cancer
• Cutaneous Squamous Cell Carcinoma (CSCC)
• Cutaneous Squamous Cell Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone Trivalent	Inactivated influenza vaccine, 0.5mL single-dose, pre-filled syringe, via intratumoral (into a tumor) injection per protocol.

Timeline

• Start date: 2024-11-26
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2024-10-29
• Last updated: 2025-10-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study