Renal Retention in High Grade Upper Tract Urothelial Cancer
Status:
Not yet recruiting
Trial end date:
2027-01-01
Target enrollment:
Participant gender:
Summary
This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for
patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no
metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care
radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable
candidates for neoadjuvant trials, as the patients intention is to forego surgery. The
patients are also not candidates for metastatic trials, as the patients have no measurable
metastasis. We hypothesize the combination of pembrolizumab and enfortumab vedotin for
patients with high grade cN0/NxMx UTUC deferring RNU will lead to event free survival
outcomes similar to that achieved by RNU in a historic dataset.
Phase:
Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators:
Astellas Pharma Inc Merck Sharp & Dohme LLC Seagen Inc.