Actively Recruiting
Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer
Led by Catherine Spina · Updated on 2025-05-20
23
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
Sponsors
C
Catherine Spina
Lead Sponsor
A
Arcus Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate adenocarcinoma
- Primary prostate tumor treated with surgery and/or radiation, with or without androgen deprivation therapy (ADT)
- One to three asymptomatic metastatic tumors of bone or soft tissue developed in the last 6 months, each less than 5 cm or 250 cm3
- Prostate-specific antigen (PSA) level greater than 0.5 ng/mL and less than 50 ng/mL
- PSA doubling time less than 15 months using all PSA values from relapse
- Testosterone level greater than 125 ng/mL
- Age 18 years or older
- Life expectancy greater than 12 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Normal organ and marrow function including leukocytes ≥3,000/mcL, neutrophils ≥1,500/mcL, platelets ≥100,000/mcL, normal bilirubin, AST/ALT ≤2.5 times upper limit of normal, and normal creatinine
- Male participants with female partners of childbearing potential must use highly effective contraception methods
- Male participants should not donate sperm for 180 days after last dose of study drugs
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Prior systemic therapy except ADT for primary tumor or salvage radiation therapy, with ADT duration not exceeding 3 years and completed over 6 months before enrollment
- Known brain metastases
- Spinal cord compression or impending spinal cord compression
- Pulmonary or liver metastases larger than 1.0 cm
- History of other malignancies within 2 years before screening except low-risk cancers
- Use of other investigational agents or treatment protocols
- Therapeutic oral or IV antibiotics within 2 weeks prior to study treatment, except prophylactic antibiotics
- Inability to swallow medication or malabsorption affecting oral medication
- Grade 3 or higher bleeding within 28 days prior to treatment
- History or evidence of pneumonitis or related lung conditions
- Severe infection within 4 weeks prior to treatment
- Positive hepatitis B core antibody test without negative HBV DNA test
- Recent use of certain drugs known to interact with etrumadenant within 4 weeks or 5 half-lives
- Immunosuppression such as solid organ transplant on immunosuppressants
- Known HIV infection or active hepatitis B or C virus infection
- Active autoimmune disease
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmia, psychiatric illness, or social situations limiting compliance
- Inability to tolerate lying flat for CT simulation and SBRT
- Use of live vaccines within 28 days before first dose of investigational products
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
Research Team
C
Catherine S. Spina, MD, PhD
CONTACT
R
Research Nurse Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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