Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atezolizumab · 1 trial · 3 indications
A positive response is defined as a ≥40% increase in the number of infiltrating cluster of differentiation 3 (CD3) + T cells between the pre-treatment biopsy at baseline and the post-treatment RP specimen. Thus, a negative response is a \<40% increase. The primary endpoint will include all enrolled subjects who receive at least 1 dose of study treatment and undergo RP. Analysis of the primary endpoint will be performed for each cohort independently
| Arm | Type | Description |
|---|---|---|
| Cohort A (atezolizumab monotherapy) | EXPERIMENTAL | Participants receive one (1) cycle of atezolizumab, 1200mg intravenously (IV) over 30-60 minutes on day 1 of a 14 day cycle. Radical Prostatectomy (RP) will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP. |
| Cohort B (atezolizumab, etrumadenant) | EXPERIMENTAL | Participants will receive one (1) cycle of atezolizumab, 1200mg intravenously (IV) over 30-60 minutes on day 1 of a 14 day cycle and etrumadenant will be taken at a dose of 150mg PO, once daily, until 48 hours prior to RP, for at least 12 days. Radical Prostatectomy (RP) will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP. |
| Cohort C (atezolizumab, tocilizumab) | EXPERIMENTAL | Participants will receive one (1) cycle of neoadjuvant atezolizumab and one (1) cycle of tocilizumab, 6mg/kg will be administered IV on day 1 of a 14 day IV prior to RP; atezolizumab will be administered in an identical fashion as Cohort A. RP will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP. |
| Name | Type | Description |
|---|---|---|
| Atezolizumab | DRUG | Given IV |
| Tocilizumab | DRUG | Given IV |
| Etrumadenant | DRUG | Given Orally |
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate. a. Subjects with small cell or neuroendocrine PC are not eligible. 2. Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy. ...
Atezolizumab is an investigational small molecule being studied for the treatment of prostate adenocarcinoma. It is currently in a Phase 2 clinical trial as a neoadjuvant therapy, given prior to radical prostatectomy in men with localized prostate cancer. The drug is not yet approved and remains in clinical development.
Atezolizumab targets CD274, also known as PD-L1, and acts as an inhibitor of this protein. By inhibiting CD274, the drug is designed to modulate the immune response against cancer cells. This mechanism is being evaluated in the context of prostate adenocarcinoma in an ongoing Phase 2 trial.
Atezolizumab is being developed by Arcus Biosciences, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol RCUS. The company is conducting clinical research on this drug for the treatment of prostate adenocarcinoma, with the drug currently in Phase 2 development.
Atezolizumab is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 2 trial is evaluating the drug as a neoadjuvant treatment for men with localized prostate cancer prior to radical prostatectomy.
Atezolizumab is being studied in one active Phase 2 clinical trial with the identifier NCT03821246. This trial is titled 'Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy' and is recruiting participants in the United States. The trial enrolls male patients aged 18 years and older.