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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Atezolizumab
DrugGiven IV
Tocilizumab
DrugGiven IV
Etrumadenant
DrugGiven Orally
Treatment groups
68 Participants
are divided into 3 treatment groupsGroup A: Cohort A (atezolizumab monotherapy)Experimental treatment 1 intervention
Group B: Cohort B (atezolizumab, etrumadenant)Experimental treatment 2 interventions
Group C: Cohort C (atezolizumab, tocilizumab)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of subjects who demonstrate a positive response to neoadjuvant atezolizumab and atezolizumab-based combination therapy for each Cohort of the study
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
Time frame
Up to 12 monthsSecondary outcomes
1
Number of treatment-related of adverse events
The number of treatment-related adverse events will be reported and classified per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame
Up to 12 months2
Sum of Pathologic complete response (pCR) and Minimal residual disease (MRD) rate
Defined as defined as the absence of tumor on the gross specimen.Will be reported following standard pathologic review of the radical prostatectomy (RP) specimen. These will be reported in sum \[pCR+ MRD) rate\] and independently.
Time frame
Up to 12 months3
Rate of Pathologic complete response (pCR) rate
Defined as defined as the absence of tumor on the gross specimen.Will be reported following standard pathologic review of the radical prostatectomy (RP) specimen. These will be reported in sum \[pCR+ minimal residual disease (MRD) rate\] and independently.
Time frame
Up to 12 months4
Rate of Minimal residual disease (MRD)
Defined as the sum of the cross-sectional diameter of residual tumors =\< 0.5 cm. Will be reported following standard pathologic review of the RP specimen. These will be reported in sum (pCR+MRD rate) and independently.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
David Oh
Lead sponsor
University of California, San Francisco
Sponsor institution
Genentech, Inc.
Collaborator
Arcus Biosciences, Inc.
Collaborator
Source ClinicalTrials.gov