~3 spots leftby Feb 2026

Atezolizumab-Based Combination Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)
+2 other locations
DO
Overseen byDavid Y Oh, MD, PhD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: David Oh
No Placebo Group
Prior Safety Data
Breakthrough Therapy

Trial Summary

What is the purpose of 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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop all current medications. However, if you are on finasteride or dutasteride, you must stop and have a 6-week washout period before joining. Also, if you are on certain medications like strong CYP3A4 inducers or inhibitors, you may need to stop them before starting the trial. It's best to discuss your specific medications with the trial team.

What data supports the idea that Atezolizumab-Based Combination Therapy for Prostate Cancer is an effective treatment?

The available research shows mixed results for Atezolizumab-Based Combination Therapy in treating prostate cancer. One study found that adding atezolizumab to enzalutamide did not improve survival in patients with metastatic prostate cancer. However, another study indicated that combining cabozantinib with atezolizumab showed promising results for patients with metastatic castration-resistant prostate cancer, especially those who had limited options after other treatments. This suggests that while the therapy may not be effective for all patients, it could be beneficial for certain groups, particularly when combined with other drugs like cabozantinib.12345

What safety data is available for Atezolizumab-based therapy?

Atezolizumab, also known as Tecentriq, has been evaluated for safety in various clinical trials. It has been approved by the FDA for use in urothelial carcinoma and non-small cell lung cancer. The toxicity profile of Atezolizumab is considered favorable, with manageable safety in patients with advanced bladder cancer and non-small-cell lung cancer. In trials, treatment-related toxicities were reported in 66% of patients, with 7-12% experiencing grade 3-4 adverse events. Overall, Atezolizumab has shown a manageable safety profile in patients with metastatic urothelial carcinoma and other cancers.678910

Is the drug Atezolizumab, Etrumadenant, Tocilizumab a promising treatment for prostate cancer?

Atezolizumab, known as Tecentriq, is a drug that has shown promise in treating various cancers by boosting the body's immune response against tumors. It has been approved for use in bladder and lung cancers, and studies suggest it could be effective when combined with other treatments. This makes it a promising option for further research in treating prostate cancer.678911

Research Team

DO

David Y Oh, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

You need to have a tumor sample that is suitable for the study analysis, as determined by the study leader.
I am 18 years old or older.
Contraception: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
See 10 more

Exclusion Criteria

I haven't taken any immune-boosting drugs in the last 4 weeks.
This does not apply to me as it is an exclusion criterion.
I have previously been treated with specific immune therapies.
See 35 more

Treatment Details

Interventions

  • Atezolizumab (Monoclonal Antibodies)
  • Etrumadenant (Other)
  • Tocilizumab (Monoclonal Antibodies)
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Siteman Cancer Center at Washington UniversitySaint Louis, MO
Alvin J. Siteman Cancer Center at Washington UniversitySaint Louis, MO
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?

David Oh

Lead Sponsor

Trials
2
Patients Recruited
50+

Lawrence Fong

Lead Sponsor

Trials
6
Patients Recruited
90+

Genentech, Inc.

Industry Sponsor

Trials
1578
Patients Recruited
569,000+

Findings from Research

Anti-PD-L1 plus enzalutamide does not improve overall survival in prostate cancer.Siddiqui, BA., Subudhi, SK., Sharma, P.[2023]
Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: results from an expansion cohort of a multicentre, open-label, phase 1b trial (COSMIC-021).Agarwal, N., McGregor, B., Maughan, BL., et al.[2022]
Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I Study.Petrylak, DP., Loriot, Y., Shaffer, DR., et al.[2022]
Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial.Powles, T., Yuen, KC., Gillessen, S., et al.[2023]
A phase III, randomized, open-label study (CONTACT-02) of cabozantinib plus atezolizumab versus second novel hormone therapy in patients with metastatic castration-resistant prostate cancer.Agarwal, N., Azad, A., Carles, J., et al.[2022]
Atezolizumab: First Global Approval.Markham, A.[2019]
Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer.Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]
Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial.Rittmeyer, A., Barlesi, F., Waterkamp, D., et al.[2022]
[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma].Bernard-Tessier, A., Bonnet, C., Lavaud, P., et al.[2019]
Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences.Tural, D., Ölmez, ÖF., Sümbül, AT., et al.[2022]
Atezolizumab for the treatment of colorectal cancer: the latest evidence and clinical potential.Tapia Rico, G., Price, TJ.[2022]

References

Anti-PD-L1 plus enzalutamide does not improve overall survival in prostate cancer. [2023]
Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: results from an expansion cohort of a multicentre, open-label, phase 1b trial (COSMIC-021). [2022]
Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I Study. [2022]
Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial. [2023]
A phase III, randomized, open-label study (CONTACT-02) of cabozantinib plus atezolizumab versus second novel hormone therapy in patients with metastatic castration-resistant prostate cancer. [2022]
Atezolizumab: First Global Approval. [2019]
Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]
Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. [2022]
[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. [2019]
Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences. [2022]
Atezolizumab for the treatment of colorectal cancer: the latest evidence and clinical potential. [2022]