Catherine Spina
This study will evaluate the safety and effectiveness of a combination of study drugs including zimberelimab, etrumadenant, and quemliclustat in combination with metastasis-directed irradiation in men with hormone sensitive oligometastatic prostate cancer. The study aims to test the hypothesis that targeted inhibition of the adenosine signaling axis (quemliclustat (CD73 antagonist) + etrumadenant (A2AR/A2BR antagonist)) and immune checkpoint inhibition (zimberelimab, α-PD-1) in combination with metastasis-directed stereotactic body radiation therapy (SBRT) will improve local control, progression-free survival (PFS), and hormone therapy-free survival and mitigate immunosuppressive changes to the tumor microenvironment (TME), compared to SBRT alone.
The optimal therapeutic approach to men with oligometastatic (1-3 or 1-5 sites of metastatic disease) prostate cancer is ever more important as advanced imaging technologies are becoming standard of care, providing clinicians with the tools to accurately diagnose and localize oligometastatic prostate cancer. Hence, methods to improve the local curative potential of stereotactic body radiation therapy (SBRT) is a timely and important opportunity. In addition, previous data suggest that the adenosine A2A pathway may be a particularly attractive avenue for intervention in the context of radiation…
Inclusion Criteria: 1. Patient must have histologically confirmed adenocarcinoma of the prostate. 2. Patient's primary prostate cancer tumor treated with surgery and/or radiation (+/- ADT). 3. Patients must have one to three asymptomatic metastatic tumors of the bone or soft tissue that developed in the preceding 6 months that are \< 5cm or \< 250 cm3. 4. Prostate-specific antigen (PSA) \> 0.5 ng/mL but \< 50ng/ml 5. PSA doubling time (PSADT) \< 15 months (using all available PSA values from time of relapse) 6. Testosterone \> 125 ng/mL 7. Age ≥18 years. 8. Patient must have life expectancy \…
100mg IV once every two weeks
150 mg orally (PO) once a day (QD)
240 mg IV once every two weeks starting within 1 week of completing metastasis-directed SBRT
Standard of care metastasis-directed hypofractionated radiotherapy treatment starting 4 weeks (+/- 1 week) of starting Etrumadenant and Quemliclustat
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