Flu Vaccine for Melanoma Patients

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Pennsylvania

Must not be taking: Immunosuppressants

Disqualifiers: HIV, Transplant history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the flu shot for individuals with melanoma, a type of skin cancer. Researchers seek to understand how well the flu vaccine works in those with advanced or metastatic melanoma. Participants will receive a standard flu shot to assess their body's response. Suitable candidates have locally advanced or metastatic melanoma and have not received a flu vaccine in the past six months. As a Phase 4 trial, the flu shot is already FDA-approved and proven effective; this research helps determine its benefits for more patients.

Will I have to stop taking my current medications?

If you are taking prednisone, methotrexate, or other medications that suppress the immune system, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What is the safety track record for the inactivated influenza vaccine?

Research has shown that the inactivated flu vaccine is generally safe, even for people with cancer. Studies have found that this vaccine does not lead to more frequent or severe immune-related side effects. Specifically, adults with cancer who received the flu shot did not experience increased emergency room visits or hospital stays, suggesting the vaccine is well-tolerated.

The flu shot is recommended for most people over six months old, including those with cancer, indicating its safety for many individuals. Therefore, participating in a trial involving the inactivated flu vaccine should not raise major safety concerns based on existing evidence. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using the inactivated influenza vaccine for melanoma patients because it taps into the body's immune system in an innovative way. While standard treatments for melanoma often involve surgery, immunotherapy, or targeted therapy, this approach uses a common flu vaccine to potentially boost the immune response against cancer cells. By administering the seasonal quadrivalent inactivated flu vaccine, the hope is to enhance the patient's ability to fight melanoma while simultaneously protecting against influenza. This dual benefit could provide a new, multifaceted strategy for managing melanoma, sparking significant interest in its potential impact.

What is the effectiveness track record for the inactivated influenza vaccine in melanoma patients?

Research has shown that the flu shot is safe and effective for cancer patients, including those with melanoma. Studies indicate that this vaccine can reduce the risk of death and improve health outcomes related to infections in adults with cancer. The INVIDIa-2 study suggested that the flu shot might strengthen the immune system in cancer patients, even those receiving immune checkpoint inhibitors, a type of cancer treatment. Clinical trials also suggested that the vaccine may help melanoma patients live longer without the cancer returning. In this trial, participants in the influenza vaccination cohort will receive one dose of the seasonal quadrivalent inactivated influenza vaccine. Overall, the vaccine serves as a useful tool for managing health in people with cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

E. John Wherry, PhD

Principal Investigator

University of Pennsyvlania

Are You a Good Fit for This Trial?

This trial is for adults who can consent and have advanced or metastatic melanoma. They shouldn't be allergic to flu vaccines, haven't had a flu shot in the last 6 months, aren't on strong immune system-suppressing drugs, don't have HIV, haven’t had an organ or bone marrow transplant, and aren't in other blood-drawing studies.

Inclusion Criteria

My melanoma has spread beyond its original site.

Exclusion Criteria

You are allergic to the flu vaccine.

You are participating in other studies that require a lot of blood to be drawn during the same time as this study.

I have had a solid organ or bone marrow transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Subjects receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immune response and safety after vaccination

3-6 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Inactivated Influenza Vaccine

Trial Overview The study is testing how well the inactivated influenza vaccine works for people with melanoma. It's a prospective study where participants know they're getting the flu vaccine to see their body's response to it.

How Is the Trial Designed?

Group I: Influenza vaccination cohort Experimental Treatment 1 Intervention

Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Phase II trials indicate that melanoma patients who develop immune responses (humoral and/or cellular) to vaccine therapy may experience improved disease-free and overall survival, despite a lack of statistically significant results in phase III trials.

The review highlights the importance of identifying the optimal combination of immune responses and effective monitoring methods to enhance the success of melanoma vaccines in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of melanoma vaccines: active specific immunotherapy for melanoma patients. Ollila, DW., Kelley, MC., Gammon, G., et al.[2019]

The dendritoma vaccine demonstrated a low toxicity profile, with all reported side effects being less than grade 3, making it a safer option for patients with stage IV melanoma.

Patients receiving three or more doses of the dendritoma vaccine had a significantly improved median overall survival of 43.1 months compared to 16.7 months for those receiving fewer doses, highlighting the importance of dosing frequency in treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I/IIa clinical trial in stage IV melanoma of an autologous tumor-dendritic cell fusion (dendritoma) vaccine with low dose interleukin-2. Greene, JM., Schneble, EJ., Jackson, DO., et al.[2021]

This clinical trial is investigating two innovative immunotherapy approaches for melanoma in 40 patients with advanced stages (IIb-IV), focusing on enhancing the immune response through novel constructs like Influenza virosomes and a recombinant Vaccinia virus.

The study will monitor safety and adverse events while assessing immunological efficacy and disease-free survival over a 2-year follow-up, aiming to refine treatment options beyond surgery for melanoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Adamina, M., Weber, WP., Rosenthal, R., et al.[2008]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melanoma vaccines: what we know so far. Bystryn, JC., Reynolds, SR.[2015]

Melanoma vaccines are considered an experimental treatment for patients who have had surgery to remove melanoma but are at high risk of recurrence, as well as for some patients with advanced disease.

There is a positive correlation between the ability of these vaccines to stimulate immune responses against melanoma and improved clinical outcomes, leading to ongoing phase III studies to better assess their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccines for melanoma. Bystryn, JC.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6938975/

Safety of Inactivated Influenza Vaccine in Cancer Patients ... No increase in incidence or severity of IRAEs was detected in patients on ICIs who received the inactivated influenza vaccine within ~ approximately 2 months ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9412390/

Safety and Efficacy of Influenza Vaccination in Patients ... Vaccination against influenza is safe, reduces mortality and improves infection-related outcomes among adults with cancer [11,12]. Consequently, annual ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00221-3/fulltext

Impact of influenza vaccination on survival of patients with ... The INVIDIa-2 study results suggest a favourable immunological impact of influenza vaccination on the outcome of cancer patients receiving ICI ...

4. withpower.com withpower.com/trial/phase-4-melanoma-9-2017-5a7a3

Flu Vaccine for Melanoma Patients · Info for Participants Clinical trials indicate that these vaccines can effectively stimulate immune responses, leading to improved outcomes such as longer recurrence-free survival ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023002213

Impact of influenza vaccination on survival of patients with ... The INVIDIa-2 study results suggest a favourable immunological impact of influenza vaccination on the outcome of cancer patients receiving ICI immunotherapy.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X24000239

The safety of seasonal influenza vaccination among adults ... Seasonal influenza vaccination was not associated with an increased incidence of ED visit or hospitalization among adults with cancer treated with ICI therapy.

7. jhoponline.com jhoponline.com/issue-archive/2021-issues/august-2021-vol-11-no-4/safety-of-inactivated-vaccines-in-patients-receiving-immune-checkpoint-inhibitors

Safety of Inactivated Vaccines in Patients Receiving ... The use of immunotherapy with inactivated influenza vaccines shows mixed safety data; few published reports involve vaccines beyond the influenza vaccine.

8. pnas.org pnas.org/doi/10.1073/pnas.1904022116

Intratumoral injection of the seasonal flu shot converts ... The seasonal influenza vaccine is recommended for all persons over 6 mo without prohibitive contraindications, including most cancer patients.