Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorDavid Oh
About this trial
This phase II trial studies how well atezolizumab works alone or in combination with etrumadenant or tocilizumab in treating men with localized prostate cancer before radical prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgens can cause the growth of prostate cancer cells. IL-6 is expressed by prostate cancer and within the tumor microenvironment and shown to enhance prostate cancer and disease progression. Treatment with an anti-IL-6 antibody such as tocilizumab may inhibit cancer progression. Giving atezolizumab in combination with etrumadenant or tocilizumab may work better in treating prostate cancer.
Eligibility criteria
Qualifiers
Histologically confirmed adenocarcinoma of the prostate.
Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy.
Only patients with high-risk disease are eligible for the safety lead-in for each cohort. Patients with intermediate-risk disease will be included after interim analyses is complete for the corresponding cohort and the PI has determined that it is safe to do so.
Availability of a representative tumor specimen that is suitable for the planned study analyses, as determined by the Principal Investigator.
Disqualifiers
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Hemoglobin >= 9 g/dL
- Participants must not have been transfused within 2 weeks prior to screening to meet this criterion
Trial design
Treatments tested in this trial
- Atezolizumab
- Tocilizumab
- Etrumadenant
Treatment groups
68 Participants
are divided into 3 treatment groupsSponsors and collaborators
David Oh
Lead sponsor
University of California, San Francisco
Sponsor institution
Genentech, Inc.
Collaborator
Arcus Biosciences, Inc.
Collaborator
Source ClinicalTrials.gov