Lay Title: CheckMate 7DX: A Study comparing Docetaxel with or without Nivolumab in Metastatic Prostate Cancer
Technical Title: A Phase 3, Randomized, Double-blind Study of Nivolumab or Placebo in Combination with Docetaxel, in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Disease Type: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Basic information: The purpose of this study is to evaluate if Nivolumab combined with Docetaxel provides benefit compared to Docetaxel alone in metastatic, castration-resistant prostate cancer (mCRPC). Nivolumab is an intravenous (into the vein) immunotherapy. Docetaxel is an intravenous, FDA-approved chemotherapy treatment for mCRPC.
Research Procedures (not a complete list): Once you begin treatment, you will need to come to clinic every 3 weeks for the first 30 weeks. Following the combination treatment, you will need to come to clinic every 4 weeks for the duration of your participation in the study. You will also need to return for scans every 9 weeks for the first year of the study, and then every 12 weeks after that.
Eligibility Criteria (not a complete list):
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ClinicalTrials.gov Identifier: NCT04100018