OncoMatch/Clinical Trials/NCT05168618
Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Is NCT05168618 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Atezolizumab and Cabozantinib S-malate for castration-resistant prostate carcinoma.
Treatment: Atezolizumab · Cabozantinib S-malate — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Prostate Cancer
Disease stage
Required: Stage IV, IVA, IVB (other)
Metastatic disease required
Patient must have non-measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria. Non-measurable disease can be bone lesions and/or extraskeletal disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: novel hormonal therapy (abiraterone acetate, enzalutamide, apalutamide, darolutamide) — metastatic castration-resistant prostate cancer
Disease progression on or after at least one prior novel hormonal therapy (NHT) (defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, darolutamide)
Cannot have received: chemotherapy for metastatic castration-resistant prostate cancer
Exception: taxane-based in metastatic castration-sensitive disease is allowed
Prior chemotherapy in the metastatic castration refractory prostate cancer setting is not allowed (taxane-based in metastatic castration-sensitive disease is allowed)
Cannot have received: cabozantinib (cabozantinib)
Prior treatment with cabozantinib
Cannot have received: immune checkpoint inhibitor (anti-CTLA-a, anti-PD1, anti-PD-L1)
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-a, anti-PD1 and anti-PD-L1 therapeutic antibodies
Lab requirements
Blood counts
ANC >= 1500/mm^3 without G-CSF support; WBC >= 2500/uL; lymphocyte count >= 0.5 x 10^9/L; platelets >= 100,000/mm^3 without transfusion in prior 2 weeks; hemoglobin >= 9 g/dL; serum albumin >= 2.5 g/dL; PT/INR or PTT < 1.5 x ULN (unless on stable anticoagulation)
Kidney function
Serum creatinine <= 1.5 x ULN or creatinine clearance >= 40 mL/min by Cockcroft-Gault formula; urine protein/creatinine ratio <= 1mg/mg or 24-hour urine protein <= 1 g
Liver function
Total bilirubin <= 1.5 x ULN (<= 3 x ULN for Gilbert's disease); AST/ALT <= 2.5 x ULN (<= 5 x ULN with liver metastases); ALP <= 3 x ULN (<= 5 x ULN with liver or bone metastases)
Absolute neutrophil count (ANC) >= 1500/mm^3 without granulocyte colony-stimulating factor support... [see full text for all details]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Huntsman Cancer Institute/University of Utah · Salt Lake City, Utah
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05168618 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy for metastatic castration-resistant prostate cancer, cabozantinib, immune checkpoint inhibitor disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV or IVA or IVB is required (metastatic disease required).
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages