Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the recommended phase II dose (RP2D) of cabozantinib s-malate (cabozantinib) and enfortumab vedotin 1.25 mg/kg on days 1, 8 and 15 of a 28-day cycle based on safety and tolerability. (Phase I dose escalation) II. To evaluate the ongoing safety and tolerability of cabozantinib and enfortumab vedotin in a dose expansion cohort. (Phase Ib dose expansion) SECONDARY OBJECTIVES: I. Obtain preliminary evidence of anti-tumor activity of the combination of cabozantinib and enfortumab vedotin by assessing the objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. II. Progression-free survival (PFS). III. Overall survival (OS). IV. Disease control rate by RECIST v1.1. EXPLORATORY OBJECTIVES: I. To assess the pharmacokinetic (PK) profile of cabozantinib during treatment with enfortumab vedotin. II. To evaluate the effect of the combination on selected biomarkers in the tumor microenvironment, systemic circulation and gut microbiome and their relationship with efficacy of the combination. III. To evaluate quality of life, frailty and sarcopenia before, during and at the time of treatment completion. OUTLINE: This is dose-escalation study of cabozantinib. Patients receive cabozantinib orally (PO) once daily (QD) on days 1-28 and enfortumab vedotin intravenously (IV) on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04878029
Study type Interventional
Source Emory University
Contact Mehmet Bilen, MD
Phone 404-778-3448
Email mbilen@emory.edu
Status Recruiting
Phase Phase 1
Start date July 23, 2021
Completion date January 21, 2025

See also
  Status Clinical Trial Phase
Completed NCT05700344 - SOGUG-AVELUMAB_RWD
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Recruiting NCT04953104 - Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression Phase 2
Withdrawn NCT06050954 - A Pilot Study of Circulating Tumor DNA Adaptive Risk Maintenance Approach for Bladder Cancer (CARMA) Phase 2
Active, not recruiting NCT03534804 - Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma Phase 2
Active, not recruiting NCT00365157 - Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction Phase 1/Phase 2
Withdrawn NCT06018116 - A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer. Phase 2
Recruiting NCT04936230 - Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer Phase 2
Recruiting NCT05544552 - Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations Phase 1/Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Terminated NCT05052372 - Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib
Terminated NCT03115801 - A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers Phase 2
Active, not recruiting NCT03854474 - Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma Phase 1/Phase 2
Terminated NCT02693717 - Pemetrexed Disodium in Treating Patients With Previously Treated Metastatic Urothelial Cancer Phase 2
Recruiting NCT04848519 - Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma Phase 2
Active, not recruiting NCT04724018 - Sacituzumab Govitecan Plus EV in Metastatic UC Phase 1
Terminated NCT04003610 - Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) Phase 2
Recruiting NCT04383067 - A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Urothelial Carcinoma Patients Phase 2
Not yet recruiting NCT03108261 - Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations Phase 2