Purpose of this Study
We are doing this study to find out if the study drug, pembrolizumab, is a safe and effective treatment for metastatic castrate-resistant prostate cancer when it is given in different combinations with other drugs. Pembrolizumab may work by increasing your immune system's response against a tumor.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with a type of metastatic castrate-resistant prostate cancer called "neuroendocrine carcinoma"</li>
<li>Have previously been treated with a drug called docetaxel</li></ul>
For more information about who can join this study, please contact the study team at julia.hurrelbrink@duke.edu.
<li>Are diagnosed with a type of metastatic castrate-resistant prostate cancer called "neuroendocrine carcinoma"</li>
<li>Have previously been treated with a drug called docetaxel</li></ul>
For more information about who can join this study, please contact the study team at julia.hurrelbrink@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will:<ul>
<li>Be assigned to take the study drug, pembrolizumab, in combination with lenvatinib, or MK-7684, or carboplatin + etoposide</li>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have imaging scans (CT and/or MRI)</li></ul>
Pembrolizumab, MK-7684, etoposide, and carboplatin are all drugs taken intravenously (through a needle in a vein in your arm). Lenvatinib is a pill that you take by mouth.
<li>Be assigned to take the study drug, pembrolizumab, in combination with lenvatinib, or MK-7684, or carboplatin + etoposide</li>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have imaging scans (CT and/or MRI)</li></ul>
Pembrolizumab, MK-7684, etoposide, and carboplatin are all drugs taken intravenously (through a needle in a vein in your arm). Lenvatinib is a pill that you take by mouth.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Jeffrey
Shevach
Protocol Number
PRO00081276
NCT ID
NCT02861573
Phase
II
Enrollment Status
Open to Enrollment