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PVSRIPO in Melanoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if PVSRIPO is safe and how it affects the injected tumor or other tumors.

What is the Condition Being Studied?

Advanced melanoma

Who Can Participate in the Study?

Adults with stage 3 or stage 4 melanoma who:
- Have been immunized against Polio virus
- Have failed other melanoma therapies

Age Group
Adults

What is Involved?

If you join the study, you will:
- Get the Polio vaccine, PVSRIPO
-- Get 1, 2 or 3 injections depending on when you start in the study
- Have a physical exam and other tests
- Imaging scans (CT scans)
- Biopsy of the tumor on your skin (or just below the skin)
- Be on the study for 12 weeks to 18 weeks, followed by a period of follow-up observation for up to 2 years

Study Details

Full Title
A Phase I trial of PVSRIPO for Patients with Unresectable Melanoma
Principal Investigator
Surgical Oncologist
Protocol Number
IRB:PRO00090774
NCT:NCT03712358
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698