This phase 2 trial will investigate the safety and effectiveness of REGN2810 with androgen deprivation therapy (ADT) and docetaxel (Taxotere) in advanced hormone-sensitive prostate cancer (hsPC).
The main outcome will be the percentage of patients with undetectable PSA (prostate-specific antigen; a marker of prostate cancer) levels. This study is recruiting in New York City, NY, the US.
The details
Prostate cancer (PC) is cancer affecting the prostate gland. Treating metastatic (advanced) PC requires multiple approaches. Chemotherapy (CT) with drugs like docetaxelis standard for many cancers. PC is also treated with androgen deprivation therapy (ADT). PC tumors can be sensitive to male hormones (androgens). ADT can slow tumor growth in hormone-sensitive PC (hsPC). Degarelix andLeuprolide acetateare ADTdrugs. Another option for PC treatment is immunotherapy (IT). These drugs target specific proteins that are highly expressed in PC. Cemiplimab (REGN2810)is an IT drug that targets the PD-1 protein.
This trial will investigate the safety of REGN2810 with ADT and docetaxel in patients with advanced hsPC. The main outcome will be the percentage of patients with undetectable PSA levels.
Who are they looking for?
This study will recruit 20 patients with advanced hsPC. Previous ADT prior to the trial is not allowed. Patients must have testosterone levels in the blood of 150 ng/dL or higher. Patients cannot have received previous CT or IT. Patients must provide tumor samples for analysis. Adequate organ function is also a requirement. Patients with female partners of childbearing age must use adequate birth control during the study and up to 4 months after the completion of the trial.
Patients cannot take part in the trial if they have had recent radiation therapy (2 weeks). Patients cannot take part if they have had an organ transplant. Autoimmune disease, immunodeficiencies, active infections, lung disease or hypersensitivity to medications are also excluded. Patients who have had a live vaccine the the past 30 days cannot participate.
How will it work
All patients will undergo combined ADT, IT and CT. This will include treatment with REGN2810, docetaxel and ADT. This treatment regimen will continue until disease progression. This will be determined by measuring PSA levels.
The main outcome will be the percentage of patients with undetectable PSA levels at 6 months.
