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

NCT04878029 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Infiltrating Bladder Urothelial Carcinoma With Squamous Differentiation
  • Locally Advanced Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Unresectable Urothelial Carcinoma

Interventions

DRUG

Cabozantinib S-malate

Given PO

DRUG

Enfortumab Vedotin

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Exelixis

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Mehmet A Bilen, MD · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-23
Primary Completion
2027-11-13
Completion
2028-12-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878029 on ClinicalTrials.gov