A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Not open
Phase: III (Cancer Control)
Principal Investigator: Teply, Benjamin
Contact Information:
Heather Mittelstedt
hmittelstedt@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06136624?term=NCT06136624&rank=1#participation-criteria
Summary
Primary Objective:
-To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to overall survival in participants with mCRPC.
-To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in participants with mCRPC.
Secondary Objectives:
-To evaluate the TFST of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
-To evaluate the OR and DOR per PCWG Modified RECIST 1.1 as assessed by BICR of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
-To evaluate the Time to Pain Progression (TTPP) of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
-To evaluate the time to PSA progression of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
-To evaluate the time to first SSRE of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
-To evaluate the safety and tolerability of MK-5684.
Exploratory Objectives:
-To identify molecular (genomic, metabolic, and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of MK-5684 and other treatments.
-To evaluate MK-5684 and alternative abiraterone acetate or enzalutamide with respect to the change from baseline disease-related symptoms and HRQoL using BPISF, FACT-P, and EQ-5D-5L questionnaires.
-To characterize the PK parameters following administration of MK-5684.
-To characterize the pharmacodynamic response following administration of MK-5684 and other treatments.