RecruitingPhase 4NCT06862219

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

A Multicenter, Phase 4, Open-label, Single-arm, Safety Study of Enfortumab Vedotin in Adult Indian Participants With Previously Treated Locally Advanced or Metastatic Urothelial Cancer


Sponsor

Astellas Pharma Global Development, Inc.

Enrollment

100 participants

Start Date

Jun 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Enfortumab Vedotin for people with metastatic urothelial carcinoma. The study is currently recruiting participants at 13 locations.

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

DRUGEnfortumab Vedotin

Intravenous Infusion


Locations(13)

Site IN91013

Patna, Bihar, India

Site IN91015

Kochi, Kerala, India

Site IN91004

Mumbai, Maharashtra, India

Site IN91016

New Delhi, National Capital Territory of Delhi, India

Site IN91017

Dumas, Surat, India

Site IN91007

Vellore, Tamil Nadu, India

Site IN91005

Varanasi, Uttar Pradesh, India

Site IN91006

Kolkata, West Bengal, India

Site IN91012

Ahmedabad, India

Site IN91010

Bhubaneswar, India

Site IN91008

Mumbai, India

Site IN91009

Nagpur, India

Site IN91001

Surat, India

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NCT06862219


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