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Cancer Vaccine

WDVAX Vaccine for Melanoma

Phase 1
Waitlist Available
Led By F. Stephen Hodi, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed Stage IV melanoma
Be older than 18 years old
Must not have
Active autoimmune disease requiring treatment for suppression of inflammation
Uncontrolled intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at a new vaccine for melanoma, which is still being studied. The goal is to find out if the vaccine is safe and effective, as well as the appropriate dose. The vaccine contains the patient's own tumor cells, which have been killed and combined with other proteins.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include reactions at the injection site due to the body's immune response to the vaccine components or allergy symptoms if there's sensitivity to any ingredient like PLGA used in the scaffold.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma is confirmed to be at stage IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for an autoimmune disease.
Select...
I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of WDVAX for Metastatic Melanoma
Safety and Biologic Activity of WDVAX

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: WDVAXExperimental Treatment1 Intervention
Treatment

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,107 Previous Clinical Trials
357,105 Total Patients Enrolled
32 Trials studying Melanoma
2,855 Patients Enrolled for Melanoma
F. Stephen Hodi, MDPrincipal InvestigatorDana-Farber Cancer Institute
12 Previous Clinical Trials
874 Total Patients Enrolled
12 Trials studying Melanoma
874 Patients Enrolled for Melanoma

Media Library

WDVAX (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT01753089 — Phase 1
Melanoma Research Study Groups: WDVAX
Melanoma Clinical Trial 2023: WDVAX Highlights & Side Effects. Trial Name: NCT01753089 — Phase 1
WDVAX (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01753089 — Phase 1
~0 spots leftby Dec 2024
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