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Metastatic Castration-Resistant Prostate Cancer Treatment Study

Clinical Trial Title: 
Phase Ib/II trial of pembrolizumab (MK-3475) combination therapies in metastatic castration-resistant prostate cancer (mCRPC) (KEYNOTE-365).
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Nicklas Pfanzelter, MD
Clinical Trial Protocol Description: 

The purpose of this study is to test the safety and tolerability of the research study drug pembrolizumab (MK-3475) in combination with other drugs in subjects with metastatic castration-resistant prostate cancer (mCRPC).

Mk-3475 Keytruda® (pembrolizumab) has been approved for use in certain types of adult melanoma and lung cancer, and head and neck cancer, however it has not been approved for metastatic mCRPC. Olaparib is another investigational drug that has shown some beneficial effect in a small study of patients with mCRPC. Docetaxel plus prednisone and enzalutamide are drugs that are approved to treat mCRPC.

mCRPC is prostate cancer that no longer responds to treatment that lowers testosterone levels and has spread to other parts of the body.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have histologically- or cytologically-confirmed (if acceptable according to local health authority regulations) adenocarcinoma of the prostate without small cell histology. Diagnosis must be stated in a pathology report and confirmed by the investigator.
  • For all Cohorts: Have provided tumor tissue from a site not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed; other exceptions may be considered after sponsor consultation). Adequacy of these specimens for biomarker analysis will be evaluated by a central laboratory prior to enrollment.
    • Cohort A: A core or excisional biopsy from soft tissue or a bone biopsy is required. This biopsy must be performed within 1 year of screening and after developing mCRPC. A recent prior archival specimen should also be provided for these subjects, if available.
    • Cohort B: An archival tumor tissue sample or tumor tissue from a fresh core or excisional biopsy from soft tissue is required.
    • Cohort C: Subjects with soft tissue disease must provide a core or excisional biopsy from a soft tissue lesion if clinically accessible. In addition to the biopsy an archival specimen should also be provided if one is available. The biopsy must be performed within 1 year of screening and after developing mCRPC. If soft tissue disease cannot be biopsied then an archival specimen is required. For subjects with bone metastasis only, an archival tumor tissue specimen must be provided.
  • Note: For all cohorts when multiple archival specimens are available, the most recent specimen is preferred. Tumor blocks are preferred. If submitting unstained cut slides, freshly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.
  • Have documented prostate cancer progression within 6 months prior to screening, asdetermined by the investigator.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had a prior anti-cancer mAb within 4 weeks prior to first dose of trial treatment or who has not recovered (ie, Grade ≤1 or at baseline) from AEs due to mAbs administered more than 4 weeks prior to first dose of trial treatment. Note: Treatment with denosumab as standard of care for bone metastases is permitted.
  • Are currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the treatment allocation.
  • Have a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to treatment allocation. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor (replacement therapy for adrenal insufficiency is permitted). Note: Treatment with palliative prednisone up to 10 mg daily or corticosteroids equivalent in the manner used to treat men with prostate cancer is permitted without sponsor notification as long as this is a stable dose prior to study entry (must be entered into the eCRF).
  • Have recovered adequately from the toxicities and/or complications, if you have undergone major surgery prior to starting therapy.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Genitourinary Cancers
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC