OncoMatch/Clinical Trials/NCT05502315
Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
Is NCT05502315 recruiting? Yes, currently enrolling (May 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
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)
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 →
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