OncoMatch/Clinical Trials/NCT04878029
Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer
Is NCT04878029 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cabozantinib S-malate and Enfortumab Vedotin for infiltrating bladder urothelial carcinoma with squamous differentiation.
Treatment: Cabozantinib S-malate · Enfortumab Vedotin — This phase I/Ib trial seeks to find out the best dose, possible benefits and/or side effects of cabozantinib in combination with enfortumab vedotin in treating urothelial cancer that has spread to nearby tissues and lymph nodes (locally advanced) or other parts of the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to a toxic agent called vedotin. Enfortumab attaches to nectin-4 tumor cells in a targeted way and delivers vedotin to kill them. Cabozantinib in combination with enfortumab vedotin may be safe and effective in treating locally advanced or metastatic urothelial cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: checkpoint inhibitor
Must have received prior treatment with a checkpoint inhibitor (CPI). A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor alone or with any other combination
Must have received: platinum-based chemotherapy
Must either have prior treatment with platinum-containing chemotherapy or be ineligible at time of enrollment
Cannot have received: cabozantinib (cabozantinib)
Prior treatment with cabozantinib
Cannot have received: antibody-drug conjugate (MMAE-based) (enfortumab vedotin)
Prior enrollment in an enfortumab vedotin study or prior treatment with other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs)
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 other systemic anticancer therapy
Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 2 weeks before first dose of study treatment
Cannot have received: radiation therapy
Radiation therapy within 2 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment
Lab requirements
Blood counts
ANC >= 1500/uL without G-CSF support; WBC >= 2500/uL; Platelets >= 100,000/uL without transfusion; Hemoglobin >= 9 g/dL
Kidney function
Calculated creatinine clearance >= 30 mL/min (>= 0.5 mL/sec) using the Cockcroft-Gault equation; Urine protein/creatinine ratio (UPCR) <= 1 mg/mg (<= 113.2 mg/mmol), or 24-hour urine protein <= 1 g
Liver function
ALT, AST, and ALP <= 3 x ULN (ALP <= 5 x ULN with documented bone metastases); Total bilirubin <= 1.5 x ULN (<= 3 x ULN for Gilbert's disease)
Cardiac function
PT/INR or PTT < 1.3 x ULN unless on anticoagulant therapy and within therapeutic range; QTcF <= 500 ms per ECG within 14 days before first dose
Absolute neutrophil count (ANC) >= 1500/uL without granulocyte colony-stimulating factor support (within 28 days before first dose of study treatment); White blood cell count >= 2500/uL (within 28 days before first dose of study treatment); Platelets >= 100,000/uL without transfusion (within 28 days before first dose of study treatment); Hemoglobin >= 9 g/dL (within 28 days before first dose of study treatment); ALT, AST, and ALP <= 3 x ULN (ALP <= 5 x ULN with documented bone metastases); Total bilirubin <= 1.5 x ULN (for subjects with Gilbert's disease <= 3 x ULN); PT/INR or PTT < 1.3 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants; Calculated creatinine clearance >= 30 mL/min (>= 0.5 mL/sec) using the Cockcroft-Gault equation; Urine protein/creatinine ratio (UPCR) <= 1 mg/mg (<= 113.2 mg/mmol), or 24-hour urine protein <= 1 g; QTcF <= 500 ms per ECG within 14 days before first dose
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
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