Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer.
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
All patients will be required to have a biopsy of a metastatic tumor deposit at study entry.
Pembrolizumab will be administered at a dose of 200 mg as a 30 minute IV infusion every 3
weeks. Enzalutamide will be continued at dose of 160 mg orally every day. Patients who have
neither rapid disease progression or disease response will undergo a fecal microbiota
transplant, have a second biopsy (if medically feasible), and be re-treated with
pembrolizumab.
Phase:
Phase 2
Details
Lead Sponsor:
Julie Graff, MD
Collaborators:
Johns Hopkins University Merck Sharp & Dohme Corp. Oregon Health and Science University Prostate Cancer Foundation