drugset / Trial / NCT04116775
Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer.
Phase 2
Unknown
32 enrolled
Julie Graff, MD
Johns Hopkins University · collabMerck Sharp & Dohme LLC · collabOregon Health and Science University · collabProstate Cancer Foundation · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-10-30
- Primary completion
- 2023-10
- Completion
- 2023-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Enzalutamide | Other / unclassified | 160 mg | Oral |