Approval Probability
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Adjusted LOA
ML Risk
Darolutamide · 1 trial · 2 indications
MRD is defined as residual cancer burden (RCB) ≤0.25cm³ at final pathology, where RCB is calculated by multiplying the residual tumor volume with the tumor cellularity. The proportion of patients who achieve MRD will be collected at the time of surgery.
| Arm | Type | Description |
|---|---|---|
| Participants with Prostate Cancer | EXPERIMENTAL | Neoadjuvant ADT plus AR- antagonist, Darolutamide plus Pembrolizumab (5 cycles) prior to radical prostatectomy (RP) in a stratified high-risk localized prostate cancer cohort, followed by adjuvant treatment with Pembrolizumab (12 cycles) post-RP. |
| Name | Type | Description |
|---|---|---|
| Darolutamide | DRUG | Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg for 16 weeks prior to RP. |
| Pembrolizumab | DRUG | Administered at the dose of 200 mg intravenously, every 3 weeks, for a total of 5 cycles prior to RP (Neoadjuvant phase, study weeks 1, 4, 7, 10, 13 \& 16), and every 3 weeks, for a total of 12 cycles post-RP (Adjuvant phase, study weeks, 19, 22, 25, 28, 31, 34, 37, 40 43, 46, 49, \& 52). Total Pembrolizumab cycles=17 |
| Lupron | DRUG | Androgen deprivation, GnRH agonist Leuprolide will be administered at a dose of 22.5 mg SQ (Eligard)/IM Lupron every 12 weeks prior to RP (Study weeks, 1 and 13). |
Inclusion Criteria: * Male Age ≥ 18 years at the time of consent * Subjects must have histopathologically confirmed adenocarcinoma of the prostate * Subjects must have unfavorable intermediate and high-risk localized or locally advanced prostate cancer (Gleason score ≥7 (4+3) and absence of distant...
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Darolutamide is an investigational small molecule being studied for the treatment of prostate cancer, specifically in molecularly stratified high-risk prostate cancer. It is being evaluated in a Phase 2 clinical trial as part of a neoadjuvant and adjuvant treatment regimen. The drug is not yet approved and remains in clinical development.
Darolutamide is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is currently conducting a Phase 2 clinical trial to evaluate the drug in patients with high-risk prostate cancer. Merck is responsible for the ongoing clinical development of this investigational therapy.
Darolutamide is currently in Phase 2 clinical development. It is being studied in an ongoing, recruiting Phase 2 trial for high-risk prostate cancer. The drug is investigational and has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated in clinical studies.
Darolutamide is being studied in a Phase 2 clinical trial registered as NCT07027124. This trial is evaluating neoadjuvant ADT plus Darolutamide with pembrolizumab, followed by adjuvant pembrolizumab in molecularly stratified high-risk prostate cancer. The study is currently recruiting participants in the United States and aims to enroll 40 patients.
Darolutamide is a small molecule developed for prostate cancer, but its specific molecular target has not been disclosed in the available clinical trial information. The ongoing Phase 2 study focuses on its use in combination with androgen deprivation therapy and pembrolizumab in high-risk prostate cancer patients.
Darolutamide is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for high-risk prostate cancer. The drug is being studied in an ongoing clinical trial, and its safety and effectiveness have not yet been established for regulatory approval.