Dumas

Researchers are evaluating enfortumab vedotin, a treatment for advanced or metastatic urothelial cancer cancer of the bladder lining, in Indian adults. This phase 4, open-label study aims to confirm the safety of enfortumab vedotin in participants whose cancer has progressed after previous treatments including checkpoint inhibitors and platinum-containing chemotherapy. Participants will receive enfortumab vedotin through intravenous infusion on days 1, 8, and 15 of each 28-day treatment cycle. This single-arm study involves repeated cycles of treatment, with all participants receiving the same study drug. The infusion schedule and dosage are designed to monitor treatment safety and tolerability. Throughout the study, participants will visit the clinic multiple times for health assessments including monitoring of adverse events, laboratory tests, vital signs, and electrocardiograms. Researchers will evaluate safety outcomes up to 8 months and also assess cancer response up to 34 months. The study involves careful tracking of participant health and treatment effects during and after the infusion cycles.