Actively Recruiting
Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Led by University of Utah · Updated on 2026-05-14
33
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests whether cabozantinib and atezolizumab work to shrink tumors in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving cabozantinib and atezolizumab may kill more tumor cells in patients with metastatic castrate-resistant prostate cancer.
CONDITIONS
Official Title
Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
- Metastatic disease progression after continuous androgen deprivation therapy for hormone sensitive state
- Non-measurable disease outside the pelvis per RECIST 1.1 criteria (bone lesions and/or extraskeletal disease)
- Disease progression on or after at least one prior novel hormonal therapy
- ECOG performance status of 0, 1, or 2
- Effective castration with serum testosterone levels ≤ 0.5 ng/mL (≤1.7 nmol/L)
- Tumor tissue available or approval from Principal Investigator if unavailable
- Adequate blood counts and organ function (ANC ≥ 1500/mm³, WBC ≥ 2500/µL, lymphocytes ≥ 0.5 x 10⁹/L, platelets ≥ 100,000/mm³, hemoglobin ≥ 9 g/dL, serum albumin ≥ 2.5 g/dL)
- Coagulation tests within specified limits or stable anticoagulation regimen
- Liver enzymes, bilirubin, alkaline phosphatase, creatinine, and urine protein within defined limits
- Agreement to use medically accepted contraception during and 5 months after study treatment
- Recovery to baseline or grade ≤ 1 CTCAE v5.0 from prior toxicities
- Able to provide informed consent and comply with protocol requirements
You will not qualify if you...
- Prior chemotherapy in metastatic castration refractory prostate cancer setting
- Prior treatment with cabozantinib, CD137 agonists, or immune checkpoint inhibitors
- Recent systemic immunostimulatory agents within 4 weeks or 5 half-lives
- Recent kinase inhibitor or other systemic anticancer therapy within specified periods
- Receiving other investigational agents
- Measurable disease outside the pelvis per RECIST 1.1 criteria
- History of leptomeningeal disease or uncontrolled tumor-related pain
- Recent radiation therapy or systemic radionuclide treatment within specified periods
- Major surgery within 4 weeks or minor surgery within 10 days before first dose
- Any other active malignancy requiring treatment within 3 years except certain localized cancers
- Known brain metastases or cranial epidural disease unless stable and treated
- Use of certain anticoagulants (coumarins, direct thrombin inhibitors, platelet inhibitors)
- Recent live attenuated vaccine administration
- Uncontrolled significant illnesses including cardiovascular, gastrointestinal, infections, or other conditions contraindicating participation
- Significant bleeding events within 12 weeks before first dose
- Cavitating pulmonary lesions or lesions invading major blood vessels
- Active or history of clinically significant autoimmune diseases with some exceptions
- Requirement for systemic immunosuppressive medication within 14 days before first dose with some exceptions
- Severe infection within 4 weeks prior to treatment
- Active infections requiring systemic treatment
- Certain viral infections unless well controlled
- History of pneumonitis or active pneumonitis on screening
- Serious non-healing wounds or malabsorption syndrome
- Uncompensated or symptomatic hypothyroidism
- Moderate to severe hepatic impairment
- Requirement for dialysis
- History of solid organ or stem cell transplant
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Uncontrolled or symptomatic hypercalcemia
- QTcF > 500 ms or history of risk factors for Torsades de pointes
- Inability or unwillingness to swallow tablets or receive IV administration
- Known severe allergic reactions to study drug components
- Medical, psychiatric, cognitive, or other conditions compromising consent or compliance
- Use of prohibited medications without adequate washout period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
S
Susan Sharry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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