Urothelial Carcinoma Clinical Trial
Official title:
Phase Ib Trial of Pembrolizumab (MK-3475) With Platinum-Based Chemotherapy in Small Cell/Neuroendocrine Cancers of Urothelium and Prostate
This phase Ib trial studies how well pembrolizumab works with combination chemotherapy in treating participants with small cell/neuroendocrine cancers of the urothelium or prostate that has spread to nearby tissue or lymph nodes or that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as etoposide, docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with platinum-based chemotherapy may work better in treating participants with small cell/neuroendocrine cancers of the urothelium or prostate.
PRIMARY OBJECTIVES: I. To evaluate the preliminary efficacy of pembrolizumab (MK-3475) in combination with standard-of-care cisplatin-based chemotherapy by assessing the durable response rate (DRR), overall response rate (ORR), duration of response (DOR), and progression free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and overall survival (OS) in Cohorts 1 and 2, and radiographic PFS (rPFS) by Prostate Cancer Working Group 3 (PCWG3) and prostate-specific antigen (PSA) response in Cohort 2. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of pembrolizumab in combination with etoposide and cisplatin/carboplatin or docetaxel and carboplatin assessed by parameters of adverse events (AEs). EXPLORATORY OBJECTIVES: I. Determine correlation of biomarkers including PD-L1 expression (PD-L1 positive >= 1% by immunohistochemistry [IHC] using 22C3 antibody), and serum and tissue molecular (including genomic, proteomic) biomarkers that may be indicative of clinic response or safety. OUTLINE: Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising either etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1), or etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days, every 9-12 weeks for up to 2 years, and then every 12 weeks thereafter. ;
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