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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Inactivated Influenza Vaccine for melanoma patients?

Research suggests that the seasonal flu vaccine, when injected directly into tumors, can turn 'cold' tumors into 'hot' ones, which are more responsive to treatment. This approach generates immune responses that help fight cancer and may improve the effectiveness of other cancer treatments. ^{1 2 3 4 5}

Is the flu vaccine safe for melanoma patients?

The research on melanoma vaccines, including those using dendritic cells and other immunotherapy approaches, shows that these treatments are generally safe and well-tolerated by patients, with minimal toxicity reported. ^{1 6 7 8 9}

How does the flu vaccine treatment differ for melanoma patients?

The flu vaccine treatment for melanoma patients is unique because it involves intratumoral injection, which turns 'cold' tumors into 'hot' ones, enhancing the immune response against the cancer. This approach repurposes the seasonal flu vaccine to stimulate the body's immune system to fight melanoma, unlike traditional treatments that do not use vaccines in this way. ^{2 4 6 10 11}

What is the purpose of this trial?

Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. We are conducting a prospective unblinded study of influenza vaccine recipients.

Research Team

E. John Wherry, PhD

Principal Investigator

University of Pennsyvlania

Eligibility Criteria

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

You are allergic to the flu vaccine.

I have had a solid organ or bone marrow transplant.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Cell-based vaccination against melanoma--background, preliminary results, and perspective. [2019]

2. United States 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. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Vaccines for melanoma. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Intratumoral injection of the seasonal flu shot converts immunologically cold tumors to hot and serves as an immunotherapy for cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Improved survival of patients with melanoma with an antibody response to immunization to a polyvalent melanoma vaccine. [2019]

6. France pubmed.ncbi.nlm.nih.gov

[The treatment of advanced malignant melanoma with vaccina oncolysates (author's transl)]. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Three antigen-loading methods in dendritic cell vaccines for metastatic melanoma. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Overview of melanoma vaccines: active specific immunotherapy for melanoma patients. [2019]

9. Germany 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Experimental melanoma vaccines. [2003]

11. United States pubmed.ncbi.nlm.nih.gov

Melanoma vaccines: what we know so far. [2015]