Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Apalutamide, Enzalutamide
AR Blockade · 1 trial · 1 indication
From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Enzalutamide Naive - Monotherapy | ACTIVE_COMPARATOR | After progression, subjects will crossover to combination therapy |
| Enzalutamide Naive - Combination therapy (Androgen Receptor Blockade + Carotuximab) | EXPERIMENTAL | Androgen Receptor is Apalutamide 240mg for Lead-In group \& Enzalutamide 160mg for all other groups |
| Enzalutamide Exposed - Combination therapy (Androgen Receptor Blockade + Carotuximab) | EXPERIMENTAL | Androgen Receptor is Apalutamide 240mg for Lead-In group \& Enzalutamide 160mg for all other groups |
| Name | Type | Description |
|---|---|---|
| AR Blockade | DRUG | Standard of care Apalutamide 240 mg / Enzalutamide 160mg administered orally and daily on Days 1-28 of every 28 day cycle |
| Carotuximab | DRUG | Carotuximab administered intravenously at the following doses: Cycle 1 Day 1: 3 mg/kg Cycle 1 Day 4: 7 mg/kg Cycle 1 Day 8: 10 mg/kg Cycle 1 Day 15: 10 mg/kg Cycle 1 Day 22: 10 mg/kg Cycle 2 Day 1: 15 mg/kg Cycle 2 Day 15: 15 mg/kg Cycle 3+ Day 1: 15 mg/kg After completion of cycle 2, dosing of carotuximab will continue at a q4 week schedule using the 15 mg/kg dose. |
Inclusion Criteria: * History of castration-resistant prostate cancer with rising PSA on a contemporary ARSI (e.g. abiraterone or, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs. * PSA rise will be defined as an increase in PSA o...