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Monoclonal Antibodies

Atezolizumab-Based Combination Therapy for Prostate Cancer

Phase 2

Recruiting

Led By Lawrence Fong, MD

Research Sponsored by David Oh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy

Must not have

Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug

Prior treatment with adenosine-axis inhibitors, CD137 agonists or immune checkpoint blockade therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy and two other drugs to see if it is effective in treating localized prostate cancer.

Who is the study for?

Men with localized prostate cancer who haven't had previous treatments for it, are over 18, in good health with proper organ and marrow function, and eligible for surgery. They must have high-risk disease for certain parts of the trial, a testosterone level above 150 ng/dL, agree to use contraception and not donate sperm.

What is being tested?

The effectiveness of Atezolizumab alone or combined with Etrumadenant or Tocilizumab is being tested before surgical removal of the prostate. The study aims to see if these treatments can help the immune system fight cancer better than current methods.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells (autoimmunity), infusion-related reactions like fever or chills, fatigue, hormonal imbalances due to anti-androgen therapy, and potential blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am approved for and agree to undergo major prostate surgery.

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I am fully active or can carry out light work.

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My organs and bone marrow are working well.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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I have not had any treatment for prostate cancer.

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My condition is considered high-risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any immune-boosting drugs in the last 4 weeks.

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I have previously been treated with specific immune therapies.

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I have had a previous transplant of stem cells or an organ.

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I have a condition that weakens my immune system.

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I have a serious heart condition.

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I need oxygen or steroids at home for my COPD.

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I have been treated with tocilizumab before.

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I have been treated with chemicals or radiation targeting my immune system.

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I have an active hepatitis B or C infection.

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I have been treated with therapies that reduce cell counts before.

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I have had radiation therapy for prostate cancer.

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I need oral steroids for my asthma.

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I have a history of specific lung conditions not caused by known factors.

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I have not received a live vaccine in the last 4 weeks.

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I have had a serious infection recently.

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My scans show cancer has spread to other parts of my body.

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I have had treatment for prostate cancer.

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I do not have any uncontrolled serious illness affecting my organs.

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I have not had major surgery in the last 4 weeks.

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I have difficulty with IV access in my arms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects who demonstrate a positive response to neoadjuvant atezolizumab and atezolizumab-based combination therapy for each Cohort of the study

Secondary study objectives

Number of treatment-related of adverse events

Prostate specific antigen (PSA) response

Rate of Minimal residual disease (MRD)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort C (atezolizumab, tocilizumab)Experimental Treatment2 Interventions

Patients 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.

Group II: Cohort B (atezolizumab, etrumadenant)Experimental Treatment2 Interventions

Patients 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.

Group III: Cohort A (atezolizumab)Experimental Treatment1 Intervention

Patients 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Etrumadenant

2019

Completed Phase 2

~380