Purpose of this Study
We are doing this study to learn if a combination of chemotherapies and immunotherapies (carboplatin, cabazitaxel, nivolumab and ipilimumab) slows cancer growth in patients with metastatic neuroendocrine or aggressive variant prostate cancer.
We also want to learn about the types of side effects that patients have while they are taking these study drugs together.
We also want to learn about the types of side effects that patients have while they are taking these study drugs together.
Who Can Participate?
Eligibility
Adults with neuroendocrine or aggressive variant prostate cancer who:<ul
<li>Have not already had an immunotherapy drug to treat their cancer</li>
<li>Have not already had cabazitaxel</li></ul>
<li>Have not already had an immunotherapy drug to treat their cancer</li>
<li>Have not already had cabazitaxel</li></ul>
Age Range
18-110
Sex/Genders
Male (cisgender)
Looking for Healthy Participants
No
What is Involved?
If you join this study you will:<ul>
<li>Get study drugs given to you through a needle in a vein in your arm every 3 weeks</li>
<li>Have imaging tests</li>
<li>Have blood and urine tests</li>
<li>Complete questionnaires</li></ul>
<li>Get study drugs given to you through a needle in a vein in your arm every 3 weeks</li>
<li>Have imaging tests</li>
<li>Have blood and urine tests</li>
<li>Complete questionnaires</li></ul>
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase II, Single Arm Study of Chemoimmunotherapy for the Treatment of Men with Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer (CHAMP)
Principal Investigator
Andrew
Armstrong
Protocol Number
PRO00106278
NCT ID
NCT04709276
Phase
II
Enrollment Status
Open to Enrollment