Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Catherine Spina
Study ID
NCT05915442
Phase
PHASE2
Status
Recruiting
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Conditions

  • Oligometastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Quemliclustat — DRUG
    100mg IV once every two weeks
  • Etrumadenant — DRUG
    150 mg orally (PO) once a day (QD)
  • Zimberelimab — DRUG
    240 mg IV once every two weeks starting within 1 week of completing metastasis-directed SBRT
  • Stereotactic Body Radiation Therapy — RADIATION
    Standard of care metastasis-directed hypofractionated radiotherapy treatment starting 4 weeks (+/- 1 week) of starting Etrumadenant and Quemliclustat

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
May 2025
Primary completion
Dec 1, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with quemliclustatm, etrumadenant, zimberelimab and SBRT
    Subjects with metastatic prostate cancer will receive quemliclustat and etrumadenant for 4 weeks prior to metastasis-directed SBRT (Stereotactic Body Radiation Therapy). Within one week of completing SBRT, subjects will also start zimberelimab.

Primary Outcome Measure

Biochemical recurrence-free survival at 12-months [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew YorkNew York10032
Research Nurse Navigator
[email protected]
212-342-5162
Catherine S. Spina, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital· New York, NY