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
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
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.
Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan.
This study is being conducted to evaluate the combination of enfortumab vedotin + pembrolizumab versus standard of care gemcitabine + platinum-containing chemotherapy, in subjects with previously untreated locally advanced or metastatic urothelial cancer.
Enfortumab vedotin may be administered for an unlimited number of cycles until a protocol defined reason for study discontinuation occurs. Pembrolizumab may be administered for a maximum of 35 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first. Cisplatin or carboplatin plus gemcitabine may be administered for a maximum of 6 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first.
Inclusion Criteria:
Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma
Measurable disease by investigator assessment according to RECIST v1.1
Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:
Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment
Archival tumor tissue comprising muscle-invasive urothelial carcinoma or a biopsy of metastatic urothelial carcinoma must be provided for PD-L1 testing prior to randomization
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
Adequate hematologic and organ function
Exclusion Criteria:
Washington D.C., District of Columbia 20007, United States
Marietta, Georgia 30060, United States
Pittsburgh, Pennsylvania 15232, United States
Greenville, South Carolina 29607, United States
Buenos Aire, C1019ABS, Argentina
CABA, C1426ANZ, Argentina
South Australia, 5112, Australia
Lueven, 3000, Belgium
Gunagzhou, 510280, China
Xicheng District, 100034, China
Praha 4-Krc, 140 59, Czechia
Villejuif-Cedex-France, 94805, France
Areezo, 52100, Italy
Kawasaki-shi, Japan
Osakasayama-Shi, Japan
Leningradskaya Oblast', 188663, Russia
Kweishan, 333, Taiwan
Muang, 40002, Thailand