Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Dama… (NCT03248570) | Clinical Trial Compass
CompletedPhase 2
Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects
United States26 participantsStarted 2018-02-20
Plain-language summary
This is a multicenter phase 2 open label study of pembrolizumab in patients with metastatic castrate resistant prostate cancer (mCRPC) with or without DNA damage repair defects.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Documented histology of adenocarcinoma of the prostate.
✓. Metastatic castration resistant prostate cancer with castrate-level testosterone (\<50 ng/dL).
✓. Disease progression defined by one or more of the following three criteria:
✓. Prostate-specific antigen (PSA) \> 2.0 ng/mL and rising PSA by at least 2 consecutive measurements a minimum of 1-week apart.
✓. Soft tissue progression as defined by RECIST v1.1 criteria.
✓. Bone disease progression as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
✓. Have received prior secondary hormonal therapy including abiraterone, enzalutamide and/or apalutamide.
✓. Be taking prednisone at a dose of ≤ 10mg/day, 7 days prior to starting treatment (Cycle 1, Day 1).
Exclusion criteria
✕. Significant liver metastasis.
✕. Prior taxane-based chemotherapy with progressive disease on chemotherapy.
✕. Prior docetaxel for metastatic hormone sensitive prostate cancer is allowed, if no progression of disease on docetaxel as defined by RECIST v1.1 and PCWG3.
✕. Prior taxane-based chemotherapy (i.e. docetaxel or cabazitaxel with or without platinum agent) for mCRPC is allowed if no progression of disease on chemotherapy as defined by RECIST v1.1 and PCWG3.
What they're measuring
1
Radiographic Progression-Free Survival Rate (rPFS) at 6 Months
Timeframe: Up to 6 months
2
Median Overall Radiographic Progression-free Survival (rPFS)
✕. Is currently participating 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 first dose of treatment.
✕. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy \>10mg/day or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
✕. Has a known history of active Bacillus Tuberculosis (TB).
✕. Hypersensitivity to pembrolizumab or any of its excipients.