WDVAX Vaccine for Melanoma

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Autoimmune disease, Uncontrolled illness, HIV, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8-16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new melanoma vaccine called WDVAX, which uses a person's own tumor cells combined with proteins that boost the immune system. The goal is to determine if this vaccine can safely help the immune system attack melanoma cells. The trial seeks individuals with Stage IV melanoma who completed previous treatments at least four weeks ago. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving other investigational study agents or have an active autoimmune disease requiring treatment, you may not be eligible to participate.

Is there any evidence suggesting that WDVAX is likely to be safe for humans?

Research has shown that WDVAX, a new vaccine being tested for melanoma, has undergone safety checks in some studies. These studies combined WDVAX with other proteins to assess how well patients with advanced melanoma could tolerate it. The primary goal was to ensure the treatment does not cause serious side effects.

In these early tests, most patients tolerated WDVAX well, experiencing no severe reactions. Some individuals may have had mild side effects, but no major safety issues emerged.

It is important to note that WDVAX is still under investigation and has not yet received FDA approval. While these early results appear promising, further studies are needed to confirm its safety in a larger group. Prospective trial participants should discuss the potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for melanoma, like immunotherapy and targeted therapy, aim to enhance the immune system or target specific mutations in cancer cells. But WDVAX works differently, as it is a vaccine designed to stimulate the body's immune response specifically against melanoma cells. Researchers are excited about WDVAX because it represents a novel approach in cancer treatment, potentially offering a personalized immune boost that targets and remembers melanoma cells. This could lead to more effective and long-lasting protection against the recurrence of the disease.

What evidence suggests that the WDVAX vaccine might be an effective treatment for melanoma?

Research has shown that the WDVAX vaccine for melanoma has promising early results. This trial will evaluate the WDVAX vaccine, which uses a patient's own tumor cells mixed with proteins to boost the immune system. One study demonstrated that WDVAX successfully activated the immune system in patients, a crucial step in fighting cancer cells. Additionally, about 43% of patients experienced stable disease, meaning their cancer did not worsen for a period. The vaccine was generally safe and well-tolerated. These early signs suggest WDVAX could be a potential treatment for melanoma. ^{1 2 6 7 8}

Who Is on the Research Team?

F. Stephen Hodi, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with Stage IV melanoma who have lived at least six months after diagnosis, haven't had treatment in four weeks, and recovered from previous therapy side effects. They must not be pregnant or breastfeeding, have no allergies to PLG (used in dissolvable stitches), no active autoimmune diseases needing suppression, no uncontrolled illnesses, and should be free of other cancers for five years.

Inclusion Criteria

It has been over 8 weeks since my last immunotherapy treatment.

My melanoma is confirmed to be at stage IV.

I have recovered from side effects of my previous treatments.

Exclusion Criteria

I have been cancer-free for 5 years, or I had treated skin cancer or cervical cancer in situ.

I am currently being treated for an autoimmune disease.

I do not have any uncontrolled illnesses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Vaccine Preparation

Surgical removal of tumor tissue for vaccine preparation and recovery

3 weeks

1 visit (in-person)

Treatment

Participants receive 4 vaccinations with WDVAX at varying intervals (every 2, 3, or 4 weeks)

8-16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with tumor assessments and side effect monitoring

3 months

3 visits (in-person)

Long-term Follow-up

Annual follow-up to monitor long-term effects and collect information on other therapies

Lifetime

Annual phone call

What Are the Treatments Tested in This Trial?

Interventions

• WDVAX

Trial Overview The study tests WDVAX—a vaccine made from a patient's own tumor cells mixed with immune-activating proteins GM-CSF and CpG within a 'scaffold' similar to dissolvable stitches material. It aims to find the safest dose with minimal side effects that can trigger an immune response against melanoma.

How Is the Trial Designed?

Group I: WDVAX Experimental Treatment 1 Intervention

Treatment

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

Canvaxin is a promising cancer vaccine that targets over 20 tumor antigens, specifically developed for treating melanoma and colon cancer.

Currently, Canvaxin is in phase III clinical trials for melanoma and phase II trials for colon cancer, indicating its progression towards potential approval and use in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology evaluation: Canvaxin, John Wayne Cancer Institute/CancerVax. Motl, SE.[2004]

In a phase I trial involving six patients with advanced colorectal cancer, a vaccine using autologous dendritic cells pulsed with melanoma cell lysate was found to be safe and well tolerated, with no observed adverse effects.

The study demonstrated that the DC-based cancer vaccine, administered intradermally in five doses over ten weeks, did not cause any toxicity, suggesting a promising approach for immunotherapy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccination with melanoma lysate-pulsed dendritic cells, of patients with advanced colorectal carcinoma: report from a phase I study. Burgdorf, SK., Fischer, A., Claesson, MH., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. aacrjournals.org aacrjournals.org/cancerimmunolres/article/13/7/978/763129/First-in-Human-Clinical-Trial-of-Vaccination-with

First-in-Human Clinical Trial of Vaccination with WDVAX, a ... In this first clinical trial of a macroscale biomaterial–based vaccine, WDVAX treatment was found to be feasible and to induce immune activation in patients ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40215342/

First-in-Human Clinical Trial of Vaccination with WDVAX, a ... Herein, we report data from a phase I trial in patients with metastatic melanoma who received the cytokine GM-CSF and the innate Toll-like ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12197434/

Melanoma Vaccines: Comparing Novel Adjuvant ... Specifically, the introduction of checkpoint inhibitors (CPIs) has improved 5-year survival to as high as 50% in patients with metastatic ...

4. acir.org acir.org/journal-articles/experimental-immunotherapy/cancer-vaccine-delivery?entryId=89038

Cancer vaccine delivery - ACIR Journal Articles WDVAX showed a favorable safety profile and manufacturing feasibility. Nine patients (42.9%) had stable disease as BOR, with an encouraging 12-month survival ...

5. aacrjournals.org aacrjournals.org/cancerimmunolres/article/doi/10.1158/2326-6066.CIR-24-0333/762894/p/First-in-Human-Clinical-Trial-of-Vaccination-with

First-in-Human Clinical Trial of Vaccination with WDVAX, a ... Herein, we report data from a phase I trial in patients with metastatic melanoma who received the cytokine GM-CSF and the innate Toll-like receptor 9 ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT01753089/

Trial | NCT01753089 It also means that the FDA has not yet approved WDVAX for any use in patients, including people with Melanoma. The purpose of this study is to determine if it ...

7. dana-farber.org dana-farber.org/clinical-trials/12-306

A Phase I Trial of a Dendritic Cell Activating Scaffold ... WDVAX for any use in patients, including people with Melanoma. The purpose of this study is to determine if it is possible to make a vaccine against melanoma by ...

8. europepmc.org europepmc.org/article/med/40215342

First-in-Human Clinical Trial of Vaccination with WDVAX, a ... Herein, we report data from a phase I trial in patients with metastatic melanoma who received the cytokine GM-CSF and the innate Toll-like receptor 9 ...