OncoMatch/Clinical Trials/NCT05048212
A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases
Is NCT05048212 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Ipilimumab for brain metastases.
Treatment: Nivolumab · Ipilimumab · Cabozantinib — A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-CTLA-4 therapy
Prior therapies for extracranial metastatic renal cell carcinoma as long as it did not include anti- CTLA-4 or cabozantinib or MET inhibitors
Cannot have received: cabozantinib (cabozantinib)
Prior therapies for extracranial metastatic renal cell carcinoma as long as it did not include anti- CTLA-4 or cabozantinib or MET inhibitors
Cannot have received: MET inhibitor
Prior therapies for extracranial metastatic renal cell carcinoma as long as it did not include anti- CTLA-4 or cabozantinib or MET inhibitors
Cannot have received: radiation therapy
Exception: radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment; systemic treatment with radionuclides within 6 weeks before first dose of study treatment
Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment.
Cannot have received: chemotherapy
Any approved anticancer therapy, including chemotherapy and hormonal therapy within 4 weeks prior to initiation of study treatment; however, the following are allowed: Hormone-replacement therapy or oral contraceptives
Cannot have received: hormonal therapy
Exception: hormone-replacement therapy or oral contraceptives allowed
Any approved anticancer therapy, including chemotherapy and hormonal therapy within 4 weeks prior to initiation of study treatment; however, the following are allowed: Hormone-replacement therapy or oral contraceptives
Cannot have received: experimental drug
Current, recent (within 3 weeks of the first infusion of this study), or planned participation in an experimental drug study
Lab requirements
Blood counts
ANC ≥1500/µL; WBC >2500/µL; Lymphocyte count ≥500/µL; Platelet count ≥100,000/µL; Hemoglobin ≥9.0 g/dL
Kidney function
Serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥40mL/min (≥0.675mL/sec) using Cockcroft-Gault equation; Urine protein/creatinine ratio (UPCR) ≤1 mg/mg (≤113.2 mg/mmol), or 24-h urine protein ≤1 g
Liver function
Total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert disease); ALT ≤3×ULN; AST ≤3×ULN; Alkaline phosphatase ≤5×ULN in patients with documented bone metastases; Serum albumin ≥2.8g/dl
Adequate hematologic and essential organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (C1D1)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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