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Concurrent VRP-HER2 Vaccine + Pembrolizumab for HER2+ Breast Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study vaccine, VRP-HER2, alone or when given with pembrolizumab is safe and has good effects in people with HER2 positive breast cancer.

What is the Condition Being Studied?

Advanced HER2+ breast cancer receiving Trastuzumab and Pertuzumab

Who Can Participate in the Study?

Adult men and women with hormone receptor negative, HER2 positive, metastatic breast cancer who are getting trastuzumab and pertuzumab.

Age Group
Adults

What is Involved?

If you choose to be in the study, you will:

Be randomly assigned (like the flip of a coin) to one of three study groups:
-- Group A: will get the study vaccine VRP-HER2 by itself
-- Group B: will get pembrolizumab by itself
-- Group C: will get VRP-HER2 plus pembrolizumab together

If you are one of the first 3 patients to be in this study, you will not by randomly assigned and will get VRP-HER2 plus pembrolizumab together.

Depending on the group you are assigned to, you will be asked to return to the Duke Clinic for study drug dosing, physical exams and other tests about 7-10 times over 6 months.

You will also have two biopsies of your tumor tissue; one before you get study drug, and one after the last dose of study drug.

Study Details

Full Title
A Phase II randomized study to evaluate the immunologic and antitumor activity of concurrent VRP-HER2 vaccination and Pembrolizumab for patients with advanced HER2-overexpressing breast cancer
Principal Investigator
Protocol Number
IRB:PRO00100093
NCT:NCT03632941
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698