WDVAX Vaccine for Melanoma

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

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of investigational melanoma vaccines. Phase I studies also try to define the appropriate dose of the investigational vaccine, in this case WDVAX, to use for further studies. "Investigational" means that the vaccine is still being studied and that research doctors are trying to find out more about it. 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 is possible to make a vaccine against melanoma by using your own melanoma tumor cells and combining them with other proteins which activate the immune system. We hope that by combining the cells and the proteins in this way that the vaccine will cause your own immune system to react against your melanoma tumor cells. The purpose of this study is also to determine the safest way to give this vaccine with the least amount of side effects. Each vaccine will contain your own tumor cells which have been killed by a freezing and thawing process which destroys the cells but keeps the proteins from the melanoma cells. This is called a "tumor lysate" Your tumor lysate is combined with other proteins which activate the immune system. The other proteins are called GM-CSF and CpG. All of this is held together to form a "tablet" or "scaffold" which is about the size of a regular aspirin tablet. The material that holds the protein together is called PLGA. PLGA is the same material that doctors use for "dissolvable stitches" If you have ever had a problem with these types of stitches in the past, be sure to let your study doctor know about this.

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.

What safety data exists for the WDVAX Vaccine for Melanoma?

In a study with a similar melanoma vaccine, no patients experienced adverse reactions, indicating it was generally safe. Another study using a different melanoma vaccine also reported no vaccine-related side effects, suggesting it was well tolerated. ^{1 2 3 4 5}

How is the WDVAX treatment for melanoma different from other treatments?

The WDVAX vaccine for melanoma is unique because it likely involves a novel approach similar to Canvaxin, which is a polyvalent vaccine containing multiple tumor antigens designed to enhance the body's immune response against melanoma, potentially improving survival rates. ^{3 6 7 8 9}

What data supports the effectiveness of the WDVAX treatment for melanoma?

Research on similar treatments like Canvaxin, a cancer vaccine, shows that it can enhance immune responses and improve survival in melanoma patients. This suggests that vaccines targeting melanoma can be effective in boosting the body's defense against the cancer. ^{3 6 7 8 10}

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

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]

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]

Citations

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

Prolonged survival after complete resection of disseminated melanoma and active immunotherapy with a therapeutic cancer vaccine. [2016]

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

Enhanced humoral immune response correlates with improved disease-free and overall survival in American Joint Committee on Cancer stage II melanoma patients receiving adjuvant polyvalent vaccine. [2016]

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

CancerVax, an allogeneic tumor cell vaccine, induces specific humoral and cellular immune responses in advanced colon cancer. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Safety and immunologic correlates of Melanoma GVAX, a GM-CSF secreting allogeneic melanoma cell vaccine administered in the adjuvant setting. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

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

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

7. Denmark pubmed.ncbi.nlm.nih.gov

[Newly diagnosed melanoma diagnosed on the basis of cutaneous side effects from COVID-19 vaccine]. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Vaccination with melanoma lysate-pulsed dendritic cells, of patients with advanced colorectal carcinoma: report from a phase I study. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Antigen-based immunotherapy of melanoma: Canvaxin therapeutic polyvalent cancer vaccine. [2020]

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

Humoral immune response to a therapeutic polyvalent cancer vaccine after complete resection of thick primary melanoma and sentinel lymphadenectomy. [2016]