A Study of Xaluritamig Plus Abiraterone Versus Investigator’s Choice in Participants with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Study Details
The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator’s choice (docetaxel, cabazitaxel, or abiraterone).
Protocol Summary
OS
Timeframe: Up to approximately 51 months
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Per Investigator Assessment
Timeframe: Up to approximately 51 months
Objective Response per Modified RECIST 1.1, Per Investigator Assessment
Timeframe: Up to approximately 51 months
Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment
Timeframe: Up to approximately 51 months
Disease Control Per Modified RECIST 1.1, Per Investigator Assessment
Timeframe: Up to approximately 51 months
Progression-free Survival (PFS) 2, Per Investigator Assessment
Timeframe: Up to approximately 51 months
Time to Response (TTR), Per Modified RECIST 1.1, Per Investigator Assessment
Timeframe: Up to approximately 51 months
Time to First Subsequent Therapy
Timeframe: Up to approximately 51 months
Time to Symptomatic Skeletal Events (SSE)
Timeframe: Up to approximately 51 months
Number of Participants With Treatment-emergent Adverse events, Treatment-emergent Serious Adverse Events, and Fatal Adverse Events
Timeframe: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in Brief Pain Inventory - Short Form (BPI-SF) Pain Intensity Scale
Timeframe: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in BPI-SF Worst Pain Score
Timeframe: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in BPI-SF Pain Interference Scale
Timeframe: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in Functional Assessment of Cancer Therapy – Prostate (FACT-P) Total Score and Subscale Scores
Timeframe: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in European Quality of Life (EuroQol) 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
Timeframe: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in the EQ-5D-5L Visual Analogue Scale (VAS)
Timeframe: Up to approximately 51 months
Time to Worsening as Measured by BPI-SF Worst Pain Score
Timeframe: Up to approximately 51 months
Time to Worsening as Measured by BPI-SF Pain Intensity Scale
Timeframe: Up to approximately 51 months
Time to Worsening as Measured by BPI-SF Pain Interference Scale
Timeframe: Up to approximately 51 months
Time to Worsening as Measured by FACT-P Total Score
Timeframe: Up to approximately 51 months
Time to Improvement as Measured by BPI-SF Worst Pain Score in Participants with Moderate/Severe Pain at Baseline
Timeframe: Up to approximately 51 months
Time to Improvement After Worsening as Measured by BPI-SF Pain Intensity Scale Score
Timeframe: Up to approximately 51 months
Time to Improvement After Worsening as Measured by BPI-SF Pain Interference Scale Score
Timeframe: Up to approximately 51 months
Summary Scores Over Time at Each Assessment as Measured by Selected Questions on Symptomatic Adverse Events from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library
Timeframe: Up to approximately 51 months
Summary Scores Over Time at Each Assessment as Measured by the GP5 Question on Overall Bother of Side Effects from the FACT-P Questionnaire
Timeframe: Up to approximately 51 months
Prostate-specific Antigen (PSA) 50 and PSA 90 Responses
Timeframe: Up to approximately 51 months
Time to PSA 50 and PSA 90 Response
Timeframe: Up to approximately 51 months
Duration of PSA 50 and PSA 90 Response
Timeframe: Up to approximately 51 months
Time to PSA Progression
Timeframe: Up to approximately 51 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Timeframe: Up to approximately 51 months
Time to Maximum Concentration (Tmax) of Xaluritamig
Timeframe: Up to approximately 51 months
Minimum Serum Concentration (Cmin) of Xaluritamig
Timeframe: Up to approximately 51 months
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig
Timeframe: Up to approximately 51 months
Accumulation Ratio of the AUC Over the Dosing Interval for Xaluritamig
Timeframe: Up to approximately 51 months
Half-life (t1/2) of Xaluritamig
Timeframe: Up to approximately 51 months
Abiraterone Serum Concentrations
Timeframe: Up to approximately 51 months
Number of Participants with Formation of Anti-xaluritamig Antibodies
Timeframe: Up to approximately 51 months