A Phase II Single Arm Study of Fecal Microbiota Transplant (FMT) in Men With Metastatic Castration Resistant Prostate Cancer Whose Cancer Has Not Responded to Enzalutamide + Pembrolizumab

NCT04116775 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Julie Graff, MD
Phase	Phase 2
Status	UNKNOWN
Enrolment	32
Start date	2019-10-30
Completion	2023-10

Conditions

• Prostate Cancer
• Prostate Cancer Metastatic

Interventions

• Fecal microbiota transplant
• Pembrolizumab
• Enzalutamide

Primary outcomes

• Anticancer effect of fecal microbiota transplant from responders to pembrolizumab to non-responders. — From 14 weeks up to 2 years
  Percentage of participants with a PSA decline of ≥ 50% at any time point on study after FMT.

Countries

United States