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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My melanoma is confirmed to be at stage IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of WDVAX for Metastatic Melanoma
Safety and Biologic Activity of WDVAX
Secondary outcome measures
Immune Response
Response to subsequent immunotherapy (E.G., anit-CTLA-4 or anti_PD-1mAbs
Survival
+1 moreTrial 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
1,078 Previous Clinical Trials
340,849 Total Patients Enrolled
32 Trials studying Melanoma
2,887 Patients Enrolled for Melanoma
F. Stephen Hodi, MDPrincipal InvestigatorDana-Farber Cancer Institute
12 Previous Clinical Trials
860 Total Patients Enrolled
12 Trials studying Melanoma
860 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been cancer-free for 5 years, or I had treated skin cancer or cervical cancer in situ.It has been over 8 weeks since my last immunotherapy treatment.I am currently being treated for an autoimmune disease.My melanoma is confirmed to be at stage IV.I do not have any uncontrolled illnesses.You have had a bad reaction to PLG before.You have HIV.I have recovered from side effects of my previous treatments.You are taking part in other research studies with experimental drugs.It has been at least 4 weeks since my last treatment.You are expected to live for at least 6 more months.
Research Study Groups:
This trial has the following groups:- Group 1: WDVAX
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings remaining for participants in this research?
"Clinicaltrials.gov suggests that this particular medical trial is no longer enlisting participants; it was initially posted on June 1st 2013, and its last update was made on August 25th 2022. Notwithstanding, there are still 753 other clinical trials open to potential patients right now."
Answered by AI
Has this therapy been granted authorization by the FDA?
"We've given this treatment a score of 1 to denote its limited data regarding efficacy and safety. As it is a Phase 1 trial, there's only preliminary evidence supporting the medication's value."
Answered by AI
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