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Merck Prostate 365 - Clinical Trial

What is the Purpose of this Study?

We are doing this study to test the safety and how well these drugs work together in patients with metastatic castrate resistant prostate cancer.

What is the Condition Being Studied?

Advanced Prostate Cancer

Who Can Participate in the Study?

Adult patients with advanced prostate cancer that has spread beyond the prostate and has gotten worse after treatment with hormones (ADT).

Age Group

What is Involved?

If you choose to join this study, you will:
- Complete a screening phase, that will include providing a tumor tissue sample, a physical exam, a blood draw, urine collection, an ECG, and imaging scans

Once you have completed the screening phase, you will:
- Get the study drug Pembrolizumab every 3 weeks through an IV, while taking standard-of-care abiraterone with prednisone by mouth daily
- Return to the clinic every 3 weeks for study visits that will include a physical exam, questions about medications and side effects, study drug infusions, and blood and urine tests
- Have Imaging scans that will be done every 9 weeks for the first year on the study then every 12 weeks

After you finish all the study visits and have finished the study treatment, you will be contacted every 6 months to see how you are doing and to see what other cancer therapies you may be on.

Study Details

Full Title
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
Principal Investigator
Medical Oncologist
Protocol Number
Phase I/II
Contact the Duke Recruitment Innovation Center