The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called ifinatamab deruxtecan (I-DXd) in treating people with metastatic castration-resistant prostate cancer (mCRPC), as compared to the standard-of-care treatment, docetaxel. The study focuses on adults who have mCRPC that has worsened after previous treatment. Researchers will also evaluate whether participants who receive I-DXd experience longer periods of time before their pain increases, compared to participants who receive docetaxel. I-DXd is an antibody drug conjugate. The goal of an antibody drug conjugate is for the antibody to bind to a tumor cell, allowing the anticancer drug to enter directly. This targeted delivery of an anticancer drug to the tumor is expected to reduce the side effects when compared to a non targeted anticancer drug. Study procedures include physical exam, imaging scans, blood and urine sample collection, tumor biopsies and drug administration. Participants will be randomly assigned to 1 of 2 groups. One group will receive I-DXd, and the other will receive docetaxel and prednisone/prednisolone. Docetaxel is the standard-of-care drug for mCRPC. Prednisone/prednisolone is a steroid that may help prevent or reduce the side effects of docetaxel.
What is the full name of this clinical trial?
MK-2400-001: A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants with Metastatic Castration-Resistant Prostate Cancer