Status:
Closed
Clinicaltrials.gov identifier:
Sponsor:
Eli Lilly and Company
Participating centers:
123 locations: United States (several centers), Australia, Belgium, Canada, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, South Korea, Netherlands, Poland, Romania, Russia, Spain, Taiwan, Turkey, United Kingdom
Accrual:
expected 524
Study Design:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy. Patient must have had disease progression while on a platinum containing regimen in the first-line setting or within 14 months after completing the first-line platinum regimen. Participants who received treatment with one immune checkpoint inhibitor regimen are eligible (for example PD-1, PDL1, or CTLA4) and may have a longer interval since prior platinum-containing therapy (≤24 months). Patients are excluded who have received prior systemic taxane therapy.
Rationale:
Ramucirumab is a monoclonal antibody that acts to inhibit vascular endothelial growth factor (VEGF); ramucirumab acts on VEGF-2. Adding this new antiangiogenic agent ramucirumab to docetaxel chemotherapy has shown promising results as a second-line therapy in advanced or metastatic urothelial carcinoma. At the Genitourinary Cancers Symposium (GUCS) in 2015.
Petrylak et al. presented a planned interim analysis of a phase 2 randomized trial that showed that the combination regimen significantly increased progression-free survival (22 weeks) as compared with docetaxel alone (10.4 weeks).
The ramucirumab plus docetaxel combination conferred a statistically significant progression-free survival improvement of greater than 11.5 weeks and reduced the risk of disease progression by 61%. Results were consistent across pre-specified subgroups and it showed an acceptable safety profile. Ramucirumab has been approved for use in gastric cancer and non–small cell lung cancer after it was shown to prolong overall survival in phase 3 second-line studies.
