PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
Background:
The immune system is the cells and organs in the body that recognize and fight infection and
cancer. The PROSTVAC vaccine might teach the immune system to find and kill certain prostate
cancer cells. Nivolumab is a drug that allows the immune system to fight tumors. Itmight help
PROSTVAC work better.
Objective:
To test the safety and effectiveness of the combination of PROSTVAC and nivolumab. To test
this for people with castration resistant prostate cancer and then for other people with
localized prostate cancer who are candidates for surgical removal of the prostate.
Eligibility:
Men ages 18 and older with prostate cancer
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Electrocardiogram
Bone scan
CT scan or MRI
Tumor sample. This may be from a previous procedure.
All participants will get a combination of the study drugs over 8 weeks. They will have 1
visit for the initial injection then 3 booster injection / nivolumab infusion visits. Blood
will be tested at these visits.
Over the next 4 weeks, some participants will have:
An exam of the large intestine through the rectum.
CT and bone scans
Standard hormonal treatment
Option to continue treatment every 3 weeks if their disease does not get worse. They will be
have scans every 12 weeks.
Other participants will have surgery to remove the prostate in week 9.
Participants will have a safety visit about a month after their last treatment. This will
include a physical exam, blood tests, and possibly scans.
If their cancer progresses, participants will leave the study and may enroll in a long-term
follow-up study. They will be contacted once a year to ask about their cancer and treatment.
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