OncoMatch/Clinical Trials/NCT05502315
Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
Is NCT05502315 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Cabozantinib and Nivolumab for castration-resistant prostate cancer.
Treatment: Cabozantinib · Nivolumab — This is a multicenter, single-arm, two-stage open-label phase 2 study of the combination of cabozantinib + nivolumab in subjects with advanced castration-resistant prostate cancer (CRPC).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Prostate Cancer
Tumor Agnostic
Disease stage
Required: Stage IV
Metastatic disease required
Progressive mCRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease as defined by PSA or radiographic progression. Subjects with measurable and non-measurable disease (i.e., bone only metastases) are allowed.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: taxane
Must have exposure to one prior taxane (or be taxane ineligible or refuse taxane)
Must have received: androgen receptor-targeting agent (abiraterone, enzalutamide, apalutamide, darolutamide)
AND one prior AR-targeting agent (for example, abiraterone, enzalutamide, apalutamide, darolutamide)
Cannot have received: checkpoint inhibitor
Exception: disease progression on prior checkpoint inhibitor treatment
Disease progression on prior checkpoint inhibitor treatment
Cannot have received: cabozantinib (cabozantinib)
Prior cabozantinib
Cannot have received: small molecule kinase inhibitor
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment
Cannot have received: cytotoxic, biologic or investigational systemic anti-cancer agent
Receipt of any type of cytotoxic, biologic or investigational systemic anti-cancer agent within 4 weeks before first dose of study treatment
Cannot have received: androgen receptor-targeting agent (abiraterone, apalutamide, darolutamide)
Treatment with abiraterone, apalutamide, or darolutamide within 2 weeks of treatment initiation
Cannot have received: androgen receptor-targeting agent (enzalutamide)
Treatment with enzalutamide within 4 weeks of treatment initiation
Cannot have received: investigational prostate cancer directed therapy
Treatment with investigational prostate cancer directed therapy within 4 weeks of treatment initiation
Cannot have received: chemotherapy
Exception: First-generation anti-androgen use (such as bicalutamide) will not be tabulated as a line of therapy.
Receipt of more than 1 line of chemotherapy (including both hormone sensitive and CRPC)
Lab requirements
Blood counts
WBC: ≥ 2,500/mcL; ANC: ≥ 1,500/mcL; Hemoglobin: ≥ 9 g/dL (transfusions are permitted); Platelet count: ≥ 100,000/mcL
Kidney function
Serum creatinine ≤ 1.5 x ULN or calculated CrCl ≥ 30 mL/min as defined by Cockcroft-Gault equation
Liver function
Total Bilirubin: ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert's disease); SGOT (AST): ≤ 3 x ULN; SGPT (ALT): ≤ 3 x ULN; Alkaline Phosphatase (ALP): ≤ 5 x ULN with documented bone metastases; Serum Albumin: ≥ 2.8 g/dL
Cardiac function
QTcF ≤ 500 ms per ECG within 14 days before first dose of study treatment
Normal organ function with acceptable initial laboratory values within 14 days of treatment start: WBC: ≥ 2,500/mcL; ANC: ≥ 1,500/mcL; Hemoglobin: ≥ 9 g/dL (transfusions are permitted); Platelet count: ≥ 100,000/mcL; Serum creatinine ≤ 1.5 x ULN or calculated CrCl ≥ 30 mL/min as defined by Cockcroft-Gault equation; Total Bilirubin: ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert's disease); SGOT (AST): ≤ 3 x ULN; SGPT (ALT): ≤ 3 x ULN; Alkaline Phosphatase (ALP): ≤ 5 x ULN with documented bone metastases; Serum Albumin: ≥ 2.8 g/dL; Urine protein/creatinine ratio (UPCR): ≤ 2 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 2 g; QTcF ≤ 500 ms per ECG within 14 days before first dose of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Diego · La Jolla, California
- University of Chicago Medical Center · Chicago, Illinois
- University of Texas Southwestern Medical Center · Dallas, Texas
- University of Wisconsin · Madison, Wisconsin
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05502315 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior checkpoint inhibitor, cabozantinib, small molecule kinase inhibitor disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV 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