Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer.
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|ClinicalTrials.gov Identifier: NCT04116775|
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : March 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Cancer Metastatic||Biological: Fecal microbiota transplant Drug: Pembrolizumab Drug: Enzalutamide||Phase 2|
To determine the anticancer effect of fecal microbiota transplant from participants who respond to pembrolizumab into those who have not responded in metastatic castration resistant prostate cancer.
The investigators propose to study the effects of fecal microbiota transplant (FMT) in patients whose disease does not respond to treatment with the combination of pembrolizumab and enzalutamide. Patients will remain on enzalutamide throughout the study and be treated with pembrolizumab for 4 cycles. Their disease will be assessed by tumor imaging. Patients whose disease responds to treatment will become stool donors to non-responders. Non-responders will undergo a second biopsy (if medically feasible) and be re-treated with pembrolizumab.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm, open-label phase II study of fecal microbiota transplant for metastatic castration-resistant prostate cancer that has not responded to treatment with pembrolizumab and enzalutamide.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2023|
INITIAL TREATMENT PHASE: Patients progressing on enzalutamide will receive 200 mg of pembrolizumab IV over 30 minutes. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily and androgen deprivation therapy.
ASSESSMENT PHASE: After completion of the initial treatment phase, patients will have their disease assessed by tumor imaging. Patients who respond to treatment will become stool donors to patients who do not respond. Non-responders will move on to the retreatment phase.
RETREATMENT PHASE: Non-responders will undergo a fecal transplant and be retreated with 200 mg of pembrolizumab IV over 30 minutes. Treatment repeats every 3 weeks for an additional 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily and androgen deprivation therapy.
Biological: Fecal microbiota transplant
A total of 100 mL of a mixture of stool and saline will be transplanted via endoscopy once.
Pembrolizumab 200 mg administered as a 30 minute infusion every 3 weeks.
Daily oral dose.
- Anticancer effect of fecal microbiota transplant from responders to pembrolizumab to non-responders. [ Time Frame: From 14 weeks up to 2 years ]Percentage of participants with a PSA decline of ≥ 50% at any time point on study after FMT.
- Percent PSA change [ Time Frame: From 12 weeks up to 2 years ]Change between baseline PSA and nadir PSA, in a negative direction. If no decrease in PSA, change between baseline PSA and PSA at 12 weeks.
- Radiographic response rate [ Time Frame: 2.5 years ]Best response: Percentage of participants who have stable disease, partial response, complete response, and progressive disease.
- Time to PSA progression [ Time Frame: 2 years ]Time from first treatment with pembrolizumab to confirmed PSA progression per PCWG3.
- Time to radiographic progression [ Time Frame: 2.5 years ]Time from first treatment with pembrolizumab to radiographic progression per PCWG3 and RECIST 1.1.
- PSA progression-free survival [ Time Frame: 2 years ]Time from first treatment with pembrolizumab to confirmed PSA progression per PCWG3 or death.
- Radiographic progression-free survival [ Time Frame: 2.5 years ]Time from first treatment with pembrolizumab to radiographic progression per PCWG3 and RECIST 1.1 or death.
- Overall survival [ Time Frame: 3 years ]Time from first treatment with pembrolizumab to death.
- Time to next therapy [ Time Frame: 2.5 years ]Time from first treatment with pembrolizumab to day 1 of the next systemic prostate cancer therapy.
- Characterization of safety profile [ Time Frame: 2.5 years ]All adverse events and their relationships to study drugs and procedures will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116775
|Contact: Carmen Iben||(503) 220-8262 ext firstname.lastname@example.org|
|United States, Oregon|
|VA Portland Health Care System||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Carmen Iben 503-220-8262 ext 59502 email@example.com|
|Principal Investigator: Julie N Graff, MD|
|Principal Investigator:||Julie N Graff, MD||Portland VA Medical Center|