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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05263050 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cabozantinib, systemic anti-cancer therapy or radiotherapy, systemic therapy directed at advanced RCC disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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