PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer

Summary

Background:

The immune system is the cells and organs in the body that recognize and fight infection and cancer. The prostate specific antigen (PSA)/TRICOM (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. It might 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

Computed tomography (CT) scan or magnetic resonance imaging (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 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.

Conditions

• Prostate Cancer

Interventions

BIOLOGICAL

PROSTVAC-V/F

PROSTVAC-V (vaccinia) will be administered subcutaneously in an extremity (e.g., thigh) at a dose of 2x10\^8 infectious units. PROSTVAC-F (fowlpox) will be administered subcutaneously in an extremity (e.g., thigh) at a dose of 1x10\^9 infectious units.

DRUG

Nivolumab

Nivolumab is to be administered as a flat dose over approximately 30-minutes via intravenous (IV) infusion.

PROCEDURE

Prostatectomy

Participants in the neoadjuvant cohort will undergo a radical prostatectomy in week 9. (If surgery is scheduled earlier than 9 weeks after initial dosing, the 6 and 8 week dosing may be skipped, and surgery may be done as early as week 5.)

PROCEDURE

Biopsy

A baseline biopsy is performed for participants in the neoadjuvant cohort that do not have a previous collection of biopsy material.

DRUG

Tylenol

Participants who experience aches or fever after vaccination may take Tylenol as directed.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• James L Gulley, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-18

Primary Completion

2023-06-20

Completion

2023-12-01

FDA Drug

Yes

Countries

• United States

Study Locations