Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enzalutamide · 1 trial · 5 indications
One-sample binomial test will be used to assess whether the proportion of PSA response (PSA decrease of at least 50%) is significantly greater than 0.05. Univariable logistic regression analysis will be conducted to assess the association between immunological parameters and PSA response responses. Scale in logit will be assessed for all continuous parameters that are identified to be significantly associated with PSA response. Descriptive statistical analysis will be conducted. The proportion estimate will be reported with 95% confidence interval.
| Arm | Type | Description |
|---|---|---|
| Treatment (pembrolizumab) | EXPERIMENTAL | INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. |
| Name | Type | Description |
|---|---|---|
| Enzalutamide | DRUG | Given PO |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Pembrolizumab | BIOLOGICAL | Given IV |
Inclusion Criteria: * ENTRY CRITERIA: Metastatic, castration resistant prostate cancer progressing on enzalutamide after initial response to enzalutamide * Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma; patients without histologically con...
Enzalutamide is being studied for the treatment of castration-resistant prostate carcinoma, including hormone-resistant prostate cancer, PSA progression, recurrent prostate carcinoma, and stage IV prostate adenocarcinoma. It is an investigational small molecule in Phase 2 clinical development for these oncology indications.
Enzalutamide is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this small molecule for the treatment of castration-resistant prostate carcinoma.
Enzalutamide is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. It is currently being evaluated in an active clinical trial for patients with castration-resistant prostate cancer.
Enzalutamide is being studied in clinical trial NCT02312557, titled 'Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide.' This Phase 2 trial is active but not recruiting, with an enrollment of 58 male patients aged 18 years and older in the United States.
Yes, Enzalutamide is also known as Enzalutamide 160 mg. This alternative name refers to the same drug, which is being investigated for the treatment of castration-resistant prostate carcinoma.
Yes, the clinical trial for Enzalutamide is biomarker-selected, meaning patients are chosen based on specific biomarker criteria. The trial is uncontrolled and not randomized or double-blinded, reflecting its early-stage design in studying this drug for prostate cancer.