Metastatic Castration-Resistant Prostate Cancer
Conditions
Brief summary
Percentage of Participants With a Decrease of ≥50% in Prostatic Specific Antigen (PSA), Number of Participants with Adverse Events (AEs), Number of Participants Discontinuing Study Drug Due to AEs, Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)
Detailed description
Disease Control Rate (DCR) Based on RECIST 1.1 Assessed by BICR, Disease Control Rate (DCR) Based on Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1 Assessed by BICR, Overall Survival (OS), Duration of Response (DOR) Based on RECIST 1.1 Assessed by BICR, Duration of Response (DOR) Based on PCWG3-modified RECIST 1.1 Assessed by BICR, ORR Based on PCWG3-modified RECIST 1.1 Assessed by BICR, Time to PSA Progression, Radiographic Progression-free Survival (rPFS) Based on PCWG3-modified RECIST 1.1 Assessed by BICR, Composite Response Rate Defined as Any One of the Following: A. Response Based on RECIST 1.1; B. PSA Decrease of ≥50%; or C. Circulating Tumor-cell Count Conversion (Pembrolizumab + Olaparib Cohort Only)
Interventions
DRUGENZALUTAMIDE
DRUGLenvatinib
DRUGCARBOPLATIN
DRUGOlaparib
DRUGPREDNISONE
DRUGMK-7684A
DRUGBelzutifan
DRUGABIRATERONE
DRUGETOPOSIDE
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGDEXAMETHASONE
DRUGDOCETAXEL
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With a Decrease of ≥50% in Prostatic Specific Antigen (PSA), Number of Participants with Adverse Events (AEs), Number of Participants Discontinuing Study Drug Due to AEs, Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) Based on RECIST 1.1 Assessed by BICR, Disease Control Rate (DCR) Based on Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1 Assessed by BICR, Overall Survival (OS), Duration of Response (DOR) Based on RECIST 1.1 Assessed by BICR, Duration of Response (DOR) Based on PCWG3-modified RECIST 1.1 Assessed by BICR, ORR Based on PCWG3-modified RECIST 1.1 Assessed by BICR, Time to PSA Progression, Radiographic Progression-free Survival (rPFS) Based on PCWG3-modified RECIST 1.1 Assessed by BICR, Composite Response Rate Defined as Any One of the Following: A. Response Based on RECIST 1.1; B. PSA Decrease of ≥50%; or C. Circulating Tumor-cell Count Conversion (Pembrolizumab + Olaparib Cohort Only) | — |
Countries
Austria, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, Sweden
Outcome results
None listed