drugset / Trial / NCT04946370
Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer
Phase 1/2
Recruiting
52 enrolled
Weill Medical College of Cornell University
Merck Sharp & Dohme LLC · collabUnited States Department of Defense · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy cancer cells). This study will assess whether 225Ac-J591 + pembrolizumab + androgen receptor inhibitor (ARI) is more effective against prostate cancer than pembrolizumab + ARI alone.
Timeline
- Start
- 2021-08-12
- Primary completion
- 2027-10
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 225Ac-J591 | Monoclonal antibody | 0.065 mbq/kg | — |
| Subject | 225Ac-J591 | Monoclonal antibody | 0.08 mbq/kg | — |
| Background | Apalutamide | Small molecule | — | Oral |
| Background | Darolutamide | Other / unclassified | — | Oral |
| Background | Enzalutamide | Other / unclassified | — | Oral |
| Background | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |