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

NCT06664151 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 24-491
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

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

Keywords

Skin Cancer; Cutaneous Squamous Cell Carcinoma; Cutaneous Squamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change of CD8+ T-cells Density

  CD8+ T-cell infiltration density (as measured by cells/mm2) on tumors is collected at the time of Mohs micrographic surgery compared to baseline (time of diagnostic biopsy).

  Up to 15 Days

Secondary Outcomes (3)

• Change in Tumor Diameter

  Up to 15 Days

• Adverse Events

  Up to 38 days

• Mean Percent Change of Tumor Microenvironment Markers Compared Before and After Intratumoral Influenza Vaccination

  Up to 15 Days

Study Arms (1)

Fluzone Vaccine in Cutaneous Squamous Cell Carcinoma

EXPERIMENTAL

Enrolled participants will complete: * Baseline visit * Days 1 and 8: Flu shot injection once * Day 15: Standard-of-care Mohs excision surgery and tissue collection. * Day 21 follow up visit with suture removal. * Day 38 follow up visit

Biological: Fluzone Trivalent

Interventions

Fluzone Trivalent BIOLOGICAL

Inactivated influenza vaccine, 0.5mL single-dose, pre-filled syringe, via intratumoral (into a tumor) injection per protocol.

Also known as: Influenza Vaccine, Flu shot

Fluzone Vaccine in Cutaneous Squamous Cell Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a diagnosis of cutaneous squamous cell carcinoma that has been biopsied and confirmed histologically. Mixed histology (such as basosquamous carcinoma, sarcomatous carcinoma) is allowed.
• Participants must have a skin tumor that measures 10 - 39 mm (not less than 10 mm and not more than 39 mm) in longest dimension by clinical exam. (Participants may have more than one untreated CSCC at the time of enrollment, but only one CSCC may be treated with the study agent.)
• Participants must be candidates for treatment (excision) by Mohs micrographic surgery.
• Age ≥18 years. Because CSCC is exceptionally rare in patients \<18 years of age, children are excluded from this study.
• ECOG performance status ≤3 (Karnofsky ≥40%, see Appendix A).
• Ability to understand and the willingness to sign a written informed consent document.
• For participants with a past medical history of Human immunodeficiency virus (HIV), they must be on effective anti-retroviral therapy with undetectable viral load measured within the 6 months prior to enrollment.
• For participants with a past medical history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• For participants with a past medical history of hepatitis C virus (HCV) infection, they must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

You may not qualify if:

• CSCC with the following high-risk features including peri-neural invasion of \>0.1 mm caliber, and invasion of tissue beyond the subcutaneous fat, and a diameter \> 3.9 cm.
• Evidence of in-transit/satellite, nodal, or distant metastases from CSCC, in the present or in the past medical history, including evidence from physical exam of primary site and draining lymph node basin.
• History of solid organ transplant or allogeneic bone marrow transplant.
• History of allergic reactions attributed to the seasonal flu vaccine.
• History of Guillain-Barré syndrome.
• Participants with any uncontrolled intercurrent illness, including uncontrolled cardiac disease (New York Heart Association Class III or IV heart failure, myocardial infarction in the 6 months prior to enrollment, unstable angina).
• Participants who are receiving any other investigational agents for treatment of cancer.
• Participants with a past medical history of another malignancy whose natural history or treatment is likely to interfere with the safety or efficacy assessment of the investigational regimen, according to the treating investigator.
• Participants with psychiatric illness/social situations that would limit compliance with study requirements.
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of intratumoral flu vaccine administration. Patients who do not agree to comply with these precautions are ineligible.
• Pregnant or nursing (breast-feeding) women are excluded from this study because there is an unknown but potential risk to multiple injections of flu vaccine in pregnant or nursing women.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Karam Khaddour, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karam Khaddour, MD

CONTACT

617-632-6571; karam_khaddour@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)