IRB #

STUDY00019692

Title

A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)

Principal Investigator

Julie Graff

Study Purpose

The purpose of the study is to compare any good and bad effects of the study drug called pembrolizumab (MK-3475) plus chemotherapy plus steroid to be better, the same, or worse than the usual approach in treating metastatic castration-resistant prostate cancer (mCRPC). Pembrolizumab has been approved by the FDA, is available by prescription to treat several different cancers, but may not for prostate cancer.

Medical Condition(s)

Prostate Cancer
Chemotherapy-naïve metastatic castration resistant prostate cancer
Pembrolizumab versus placebo plus docetaxel with prednisone

Eligibility Criteria

- Metastatic prostate cancer patient who may previously be treated with next-generation AR-targeted therapy abiraterone acetate or enzalutamide without prior chemotherapy treatment for mCRPC
- Subjects' prostate cancer progressed despite previous androgen deprivation therapy or anti-androgen therapies.
- Subject must supply a newly biopsied tumor tissue or have a tumor tissue previously collected from a previous procedure.
- Subjects have not had an active autoimmune disease that has required systemic treatment in past 2 years.
- Subjects have not had a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent)

Age Range

18 - NA

Healthy Volunteers Needed

No

Duration of Participation

Up to 24 months

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Merck Sharp & Dohme Corp., (a subsidiary of Merck & Co. Inc.)

Recruitment End

12/31/2021

Compensation Provided

No


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