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OncoMatch/Clinical Trials/NCT06862219

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

Is NCT06862219 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Enfortumab Vedotin for metastatic urothelial carcinoma.

Phase 4RecruitingAstellas Pharma Global Development, Inc.NCT06862219Data as of May 2026

Treatment: Enfortumab VedotinThis 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.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: anti-PD-1 therapy — locally advanced or metastatic

radiographic progression or relapse during or after a checkpoint inhibitor (CPI) (anti-PD-1 or anti-PD-L1) for locally advanced (LA) or metastatic disease

Must have received: anti-PD-L1 therapy — locally advanced or metastatic

radiographic progression or relapse during or after a checkpoint inhibitor (CPI) (anti-PD-1 or anti-PD-L1) for locally advanced (LA) or metastatic disease

Must have received: platinum-based chemotherapy (cisplatin, carboplatin) — metastatic / LA, neoadjuvant or adjuvant

must have received a platinum-containing regimen (cisplatin or carboplatin) in the metastatic / LA, neoadjuvant or adjuvant setting. If platinum was administered in the adjuvant/neoadjuvant setting, the participant must have progressed within 12 months of completion.

Cannot have received: antibody-drug conjugate (enfortumab vedotin, monomethyl auristatin E (MMAE)-based ADC)

prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody drug conjugate (ADCs)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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