OncoMatch/Clinical Trials/NCT05263050
Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors
Is NCT05263050 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cabozantinib and Nivolumab for metastatic renal cell carcinoma.
Treatment: Cabozantinib · Nivolumab — This is a multi-site, three-cohort phase II trial of cabozantinib for IMDC all-risk frontline metastatic renal cell carcinoma (mRCC) patients OR any line mRCC patients who have not previously been treated with cabozantinib, and patients with pancreatic or extra-pancreatic neuroendocrine tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Neuroendocrine Tumor
Disease stage
Required: Stage IV
Metastatic disease required
advanced RCC with any clear cell or non-clear cell component; Well differentiated NET, grades 1-3 (any primary site); At least one measurable lesion as defined by RECIST version 1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: somatostatin analog — prior or concurrent
Prior or concurrent treatment with somatostatin analogue allowed but no limit on lines of therapy (stable dose of somatostatin for 2 months)
Cannot have received: cabozantinib (cabozantinib)
Patients with prior therapy with cabozantinib.
Cannot have received: systemic anti-cancer therapy or radiotherapy
Exception: within 14 days or five half-lives, whichever is shorter, prior to entering the study
Patients who have had systemic anti-cancer therapy or radiotherapy within 14 days or five half-lives, whichever is shorter, prior to entering the study.
Cannot have received: systemic therapy directed at advanced RCC
Exception: not allowed for patients enrolled to Cohort B (treatment-naïve group)
Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to Cohort B (treatment-naïve group).
Lab requirements
Blood counts
Leukocytes > 2,000/mcL; Absolute neutrophil count > 1,500/mcL; Platelets > 100,000/mcL; Hgb > 9 g/dL (>90 g/L)
Kidney function
Creatinine clearance > 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Liver function
Total bilirubin ≤ 1.5 x ULN (Gilberts syndrome <3.0 mg/dL); AST/ALT/ALP < 3 x ULN; ALP ≤ 5x ULN with documented bone metastases; Albumin > 2.8 g/dL
Cardiac function
PT/INR or PTT < 1.3 x the laboratory ULN; QTcF > 500 msec within 28 days before first dose of study treatment; Congestive heart failure NYHA Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias excluded
Patients must have normal organ and marrow function as defined below * Leukocytes, > 2,000/mcL * Absolute neutrophil count, > 1,500/mcL * Platelets, > 100,000/mcL * Hgb, > 9 g/dL (>90 g/L) * Total bilirubin, ≤ 1.5 x ULN (with the exception of of individuals with Gilberts syndrome who may have a bilirubin <3.0 mg/dL) * AST/ALT (SGOT/SGPT)/ALP, < 3 x ULN ALP ≤ 5x ULN with documented bone metastases. * Albumin, > 2.8 g/dL * Creatinine clearance, > 30 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal * PT/INR or PTT, < 1.3 x the laboratory ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fox Chase Cancer Center · Philadelphia, Pennsylvania
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