Pembrolizumab for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJulie Graff, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well pembrolizumab works in treating patients with prostate cancer that has spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels despite previous treatment with enzalutamide. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells.

Eligibility Criteria

This trial is for men with prostate cancer that has spread and doesn't respond to low testosterone or enzalutamide treatment. They must have good blood counts, liver and kidney function, be willing to use contraception, and not have had certain other treatments recently.

Inclusion Criteria

My kidney function is within the required range for the study.

My blood clotting time is normal or managed if I'm on blood thinners.

My prostate cancer is confirmed and not purely small cell type.

See 15 more

Exclusion Criteria

I have been diagnosed with HIV.

I do not have an active severe autoimmune disease needing strong treatment in the last 3 months.

My cancer is quickly worsening, and my doctor thinks docetaxel could help.

See 19 more

Treatment Details

Interventions

Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe study tests pembrolizumab's effectiveness in patients whose prostate cancer continues to grow after enzalutamide treatment. Pembrolizumab is a monoclonal antibody designed to block tumor growth by targeting specific cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab)Experimental Treatment3 Interventions

INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: