Study on Pembrolizumab for Treating Metastatic Castration-Resistant Prostate Cancer After Enzalutamide Treatment

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60

ClinicalTrials ID:NCT02312557

This clinical trial is exploring how well the drug pembrolizumab works in treating prostate cancer that has spread and continues to grow despite low testosterone levels and previous treatment with enzalutamide. Pembrolizumab is a type of monoclonal antibody that may help block tumor growth by targeting specific cells.

Patient Parameters

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Program Overview

This phase II study is testing the effectiveness of pembrolizumab in men with prostate cancer that has spread to other parts of the body and continues to grow even when testosterone levels are very low, despite previous treatment with enzalutamide. Pembrolizumab is a monoclonal antibody that may help stop tumor growth by targeting certain cells.

Description

The study has several goals:

Primary Goal: To measure how well pembrolizumab works against prostate cancer that has spread and is resistant to low testosterone levels.
Secondary Goals: To explore immune and genetic factors that might predict how well patients respond to pembrolizumab, to collect and analyze circulating tumor cells, to monitor changes in T cells and inflammatory markers, and to assess disease response through imaging and PSA levels.
Tertiary Goals: To conduct additional genetic and protein analyses to better understand the effects of immunotherapy.

Treatment Plan:

Initial Treatment: Patients whose cancer is progressing on enzalutamide will receive pembrolizumab through an IV every three weeks for four cycles, while continuing to take enzalutamide daily.
Monitoring Phase: After the initial treatment, patients will continue taking enzalutamide daily.
Retreatment Phase: Patients who respond or have stable disease after the initial treatment may receive another four cycles of pembrolizumab, while continuing enzalutamide.

After completing the study treatment, patients will have follow-up visits at 30 days, and then every 12 weeks for 2.5 years.

Eligibility Criteria

Inclusion Criteria

Have metastatic prostate cancer that continues to grow despite low testosterone levels and treatment with enzalutamide.
Have a confirmed diagnosis of prostate adenocarcinoma.
Be willing to provide informed consent.
Be 18 years or older.
Have metastatic disease.
Allow access to a tissue sample, if available.
Have a tumor that can be biopsied.
Have a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
Meet specific blood count and organ function criteria.
Agree to use contraception during and after the study.
Have PSA or radiographic progression on enzalutamide.
Have had surgical castration or be on hormone therapy to keep testosterone levels low.

Exclusion Criteria

Currently participating in another investigational study or have used an investigational device recently.
Have an immune deficiency or are on immunosuppressive therapy.
Have had a monoclonal antibody treatment recently.
Have had chemotherapy for castration-resistant disease.
Have another progressing cancer requiring treatment.
Have known brain metastases or carcinomatous meningitis.
Have a history of seizures.
Have an allergy to enzalutamide.
Have an active autoimmune disease requiring treatment.
Have a history of severe lung inflammation.
Have an active infection requiring treatment.
Have a condition that might interfere with the study.
Have psychiatric or substance abuse disorders affecting study participation.
Have received certain immune therapies before.
Have plans to receive other cancer treatments during the study.
Have a history of HIV or active hepatitis B or C.
Have received a live vaccine recently.
Have rapidly progressing disease that requires different treatment.

Locations

FACILITY	ZIP	CITY	STATE
OHSU Knight Cancer Institute	97239	Portland	Oregon

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