Skin CancerEarly Phase 1NCT06664151
A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision
A Early Phase 1 study testing Fluzone Trivalent in people with Skin Cancer and Cutaneous Squamous Cell Carcinoma (CSCC), run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Cutaneous Squamous Cell Carcinoma (CSCC), Cutaneous Squamous Cell Cancer
- What is being tested?
- Fluzone Trivalent
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Nov 2024to 30 Aug 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
- Note: Previous treatment with flu vaccination is not an exclusion criterion. Routine intramuscular seasonal influenza vaccination is not required nor prohibited.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Karam Khaddour, MD, 617-632-6571, karam_khaddour@dfci.harvard.edu
Karam Khaddour, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Karam Khaddour, MD, 617-632-6571, karam_khaddour@dfci.harvard.edu
Karam Khaddour, MD
About this study
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)
Read the 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.
- Being tested
- Fluzone Trivalent
- Keywords
- Skin Cancer, Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Cancer
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone TrivalentBiological
Also called Influenza Vaccine, Flu shot
Inactivated influenza vaccine, 0.5mL single-dose, pre-filled syringe, via intratumoral (into a tumor) injection per protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Fluzone Trivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 15 Days
Secondary outcomes (3)
Change in Tumor Diameter
Evaluate the change in tumor diameter based on day 1 screening and the biopsy from the time of diagnosis.
Measured: Up to 15 Days
Adverse Events
Adverse events rate is defined as the percentage of participants who have experienced adverse events based on CTCAE 5.0
Measured: Up to 38 days
Mean Percent Change of Tumor Microenvironment Markers Compared Before and After Intratumoral Influenza Vaccination
Evaluation of the differences of effect on the mean percent change of tumor microenvironment markers before and after the administration of intratumoral influenza vaccine in CSCC lesions
Measured: Up to 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start26 Nov 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karam Khaddour, MD, MS, Dana-Farber Cancer Institute
- Investigators
- Karam Khaddour, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664151
- Sponsor's protocol ID
- 24-491
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.