RecruitingPhase 1NCT04878029

Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer

A Phase I/Ib Open Label, Single-Arm Study of Cabozantinib in Combination With Enfortumab Vedotin (EV) in the Treatment of Locally Advanced or Metastatic Urothelial Cancer


Sponsor

Emory University

Enrollment

32 participants

Start Date

Jul 23, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests the combination of cabozantinib (a drug that blocks tumor blood vessel growth) with enfortumab vedotin (an antibody that delivers chemotherapy directly to cancer cells) in patients with bladder and urinary tract cancer that has spread or cannot be surgically removed and has already received prior immunotherapy and/or platinum chemotherapy. **You may be eligible if...** - You are 18 or older with confirmed urothelial carcinoma (cancer of the bladder, ureter, renal pelvis, or urethra) that has spread - You have previously received an immunotherapy drug (PD-1 or PD-L1 inhibitor) - You have had prior platinum-based chemotherapy or are ineligible for it - You have at least one measurable tumor on imaging - Your overall health score is 2 or below (ECOG), and your blood counts and organ function meet the study requirements **You may NOT be eligible if...** - You have not had prior immunotherapy - You have significant unresolved side effects from prior treatment - You do not have tumor tissue available for testing - You have serious heart, kidney, or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabozantinib S-malate

Given PO

DRUGEnfortumab Vedotin

Given IV

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT04878029


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