At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed unresectable locally advanced or metastatic urothelial carcinoma
- ✓Measurable disease per RECIST v1.1 (including outside prior radiation fields or with unequivocal progression)
- ✓No prior systemic therapy for locally advanced/metastatic UC; prior neoadjuvant or adjuvant chemotherapy allowed if recurrence >12 months after completion
- ✓Eligible to receive cisplatin- or carboplatin-containing chemotherapy per investigator judgment
- ✕Prior enfortumab vedotin or MMAE-based antibody-drug conjugates
- ✕Prior PD-1 or PD-L1 inhibitor treatment for any malignancy
- ✕Prior treatment with other T-cell co-inhibitory agents
- ✕Uncontrolled diabetes
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
In Brief
A Phase 3 clinical trial evaluating Enfortumab vedotin, Pembrolizumab, and 3 other interventions for Urothelial Cancer. Active but no longer recruiting, targeting 886 participants across 260 sites in 25 countries.
Detailed Summary
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Study Details
Timeline
Interventions
Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
IV infusion on Day 1 of every 3-week cycle
administered as IV infusion on Day 1 of each 3-week cycle
Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
IV infusion on Days 1 and 8 of every 3 week cycle