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OncoMatch/Clinical Trials/NCT05931393

Sequential Treatment of Cabozantinib for Advanced Renal Cell Carcinoma (RCC)

Is NCT05931393 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cabozantinib 80 MG for rcc.

Phase 2RecruitingUniversity of Texas Southwestern Medical CenterNCT05931393Data as of May 2026

Treatment: Cabozantinib 80 MGThe goal of this clinical trial is to learn about the effects of a higher dose of ncabozantinib in patients with advanced renal cell carcinoma who have progressed on or after receiving cabozantinib treatment.

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Extracted eligibility criteria

Cancer type

Renal Cell Carcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: cabozantinib (cabozantinib)

progressed on/after cabozantinib monotherapy in any line of treatment. Patient must have cabozantinib sensitive disease (prior treatment with cabozantinib ≥ 6 months)

Lab requirements

Blood counts

ANC ≥ 1500/µL without G-CSF support; WBC count ≥ 2500/µL; Platelets ≥ 100,000/µL without transfusion; Hemoglobin ≥ 9 g/dL (transfusion acceptable per investigator discretion); PT/INR or PTT < 1.3x ULN

Kidney function

Serum creatinine ≤ 1.5x ULN or calculated creatinine clearance ≥ 40mL/min (≥ 0.675mL/sec) using the Cockcroft-Gault equation; Urine protein/creatinine ratio (UPCR) ≤1 mg/mg (≤113.2 mg/mmol), or 24h urine protein ≤1 g

Liver function

ALT, AST and ALP ≤ 3 x ULN. ALP ≤ 5x ULN with documented bone metastases; Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3x ULN); Serum albumin ≥ 2.8 g/dl

Cardiac function

QTcF ≤ 500 ms per ECG within 14 days before first dose; history of additional risk factors for torsades de pointes (e.g., long QT syndrome) are excluded

Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment: ... (see full criteria above); Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment. Furthermore, subjects with a history of additional risk factors for torsades de pointes (e.g., long QT syndrome) are also excluded.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UT Southwestern Medical Center · Dallas, Texas

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