MedTrace Logo

A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer

NCT06862219 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-06

No results posted yet for this study

Summary

This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer.

The main aim of the study is to confirm the safety of enfortumab vedotin in Indian adults with urothelial cancer.

During the study, people will receive enfortumab vedotin. The study treatment will be given to people slowly through a tube into a vein. This is called an infusion. People will receive 3 separate infusions of enfortumab vedotin in each 28-day (4 weeks) treatment cycle.

People visit their study clinic for health-checks several times during and after they receive enfortumab vedotin.

Conditions

  • Metastatic Urothelial Carcinoma

Interventions

DRUG

Enfortumab Vedotin

Intravenous Infusion

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Pharma Global Development, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-21
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • India

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 NCT06862219 on ClinicalTrials.gov