36 Participants Needed

Flu Vaccine for Melanoma

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain immunosuppressive medications or corticosteroids above a specific dose within 14 days of the study.

What data supports the effectiveness of the treatment for melanoma?

Research shows that vaccines can stimulate immune responses against melanoma, potentially improving survival and reducing cancer markers in the blood. Additionally, a study found that a similar vaccine approach led to increased immunity and stable disease in some melanoma patients.12345

Is the flu vaccine safe for use in humans?

Clinical trials have shown that vaccines, including those for melanoma, are generally safe to use and have much less toxicity than current therapies for melanoma. In a study with a polyvalent melanoma vaccine, there was no toxicity other than temporary skin reactions at the injection site.13467

How does the Flu Vaccine treatment differ from other melanoma treatments?

The Flu Vaccine for Melanoma is unique because it uses a common flu vaccine to potentially stimulate the immune system against melanoma, unlike traditional treatments that focus on specific melanoma antigens. This approach is novel as it leverages the immune response typically generated by flu vaccines to target cancer cells.158910

What is the purpose of this trial?

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.

Research Team

CM

Carlo M. Contreras, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults aged 18-99 with stage I-IV cutaneous melanoma. Participants must have at least one palpable tumor deposit suitable for injection and be in good physical condition (ECOG PS 0-1). Exclusions include allergies to flu vaccines, recent immunosuppressants use, autoimmune diseases, ocular/mucosal melanoma, brain metastasis, recent melanoma therapy except surgery, incarceration, HIV positivity or pregnancy.

Inclusion Criteria

I am fully active or can carry out light work.
I have a melanoma tumor that can be felt and measured to be at least 1 cm.
My skin cancer is confirmed as melanoma and is in an early or advanced stage.

Exclusion Criteria

I have an autoimmune disease.
You have had a biopsy to diagnose melanoma in your eye or on a mucous membrane.
I am unable to give consent on my own.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive quadrivalent inactivated influenza vaccine intramuscularly on day 0 and intratumorally on specified days, with surgery on day 28 for Cohort I and additional intratumoral doses for Cohort II

14 weeks
Multiple visits for intratumoral injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Treatment Details

Interventions

  • Quadrivalent Inactivated Influenza Vaccine
Trial Overview The study tests if injecting the influenza vaccine directly into a melanoma tumor can reduce its size or spread. It's a phase I trial that also involves standard therapies like Ipilimumab and Nivolumab. Patients are grouped based on their cancer stage and receive either intralesional vaccine plus other treatments or those treatments alone.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort II (unresectable Stage IV)Experimental Treatment5 Interventions
Patients receive an 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 (single- or dual-agent) ipilimumab, nivolumab, relatlimab, or pembrolizumab.
Group II: Cohort I (resectable Stage I-III melanoma)Experimental Treatment2 Interventions
Patients receive an influenza vaccine 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.

Quadrivalent Inactivated Influenza Vaccine is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸
Approved in United States as Quadrivalent Inactivated Influenza Vaccine for:
  • Influenza prophylaxis
🇪🇺
Approved in European Union as Quadrivalent Inactivated Influenza Vaccine for:
  • Influenza prophylaxis
🇨🇦
Approved in Canada as Quadrivalent Inactivated Influenza Vaccine for:
  • Influenza prophylaxis
🇯🇵
Approved in Japan as Quadrivalent Inactivated Influenza Vaccine for:
  • Influenza prophylaxis
🇨🇳
Approved in China as Quadrivalent Inactivated Influenza Vaccine for:
  • Influenza prophylaxis
🇨🇭
Approved in Switzerland as Quadrivalent Inactivated Influenza Vaccine for:
  • Influenza prophylaxis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carlo Contreras

Lead Sponsor

Trials
1
Recruited
40+

Findings from Research

Vaccines for melanoma are considered safe and have lower toxicity compared to current treatments, making them a promising option for patients.
Clinical trials indicate that these vaccines can effectively stimulate immune responses, leading to improved outcomes such as longer recurrence-free survival in patients compared to control groups.
Melanoma vaccines: what we know so far.Bystryn, JC., Reynolds, SR.[2015]
Despite significant advancements in understanding melanoma antigens and immune responses through decades of research, achieving lasting clinical benefits from melanoma vaccines remains rare.
Recent clinical trials involving CTLA-4 inhibitors and BRAF inhibitors show promise, suggesting that combining these therapies with active immunotherapy could enhance long-term control of melanoma.
Melanoma vaccines: developments over the past 10 years.Klein, O., Schmidt, C., Knights, A., et al.[2012]
In a study of 27 patients with advanced colon cancer, the CancerVax vaccine significantly increased immune responses, specifically anti-TA90 IgG and IgM titers, which correlated with improved overall survival rates, particularly in patients with higher IgM levels.
The median overall survival for patients receiving CancerVax was 21.9 months, and peak IgMTA90 titer was identified as a significant predictor of survival, suggesting that the vaccine may enhance patient outcomes in advanced colon cancer.
CancerVax, an allogeneic tumor cell vaccine, induces specific humoral and cellular immune responses in advanced colon cancer.Habal, N., Gupta, RK., Bilchik, AJ., et al.[2020]

References

Melanoma vaccines: what we know so far. [2015]
Melanoma vaccines: developments over the past 10 years. [2012]
CancerVax, an allogeneic tumor cell vaccine, induces specific humoral and cellular immune responses in advanced colon cancer. [2020]
Preparation and characterization of a polyvalent human melanoma antigen vaccine. [2007]
Heterologous prime-boost immunotherapy of melanoma patients with Influenza virosomes, and recombinant Vaccinia virus encoding 5 melanoma epitopes and 3 co-stimulatory molecules. A multi-centre phase I/II open labeled clinical trial. [2008]
Cancer vaccines with emphasis on a viral oncolysate melanoma vaccine. [2020]
A phase I/IIa clinical trial in stage IV melanoma of an autologous tumor-dendritic cell fusion (dendritoma) vaccine with low dose interleukin-2. [2021]
Clinical and immunological responses in metastatic melanoma patients vaccinated with a high-dose poly-epitope vaccine. [2020]
Emerging melanoma vaccines. [2007]
Immune response to postsurgical adjuvant active immunotherapy with Canvaxin polyvalent cancer vaccine: correlations with clinical course of patients with metastatic melanoma. [2007]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security