Neoadjuvant Combination Pembrolizumab / Enfortumab Vedotin With Adjuvant Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Carcinoma
Jonsson Comprehensive Cancer Center
Summary
This phase II clinical trial tests how well pembrolizumab plus enfortumab vedotin prior to and after radical nephroureterectomy works in treating patients with high-risk upper tract urothelial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Enfortumab vedotin (EV) is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Radical nephroureterectomy (RNU) is the surgical removal of a kidney and its ureter. Giving pembrolizumab plus enfortumab vedotin before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed and giving pembrolizumab after surgery may kill any remaining cancer cells.
Description
PRIMARY OBJECTIVES: I. To assess pathologic objective response rate (ORR; complete response \[CR; pT0\] and partial response \[PR; \< pT2\] rate) at the time of radical nephroureterectomy. II. To assess recurrence-free survival post radical nephroureterectomy. SECONDARY OBJECTIVE: I. To describe the side effect profile, tolerability, and surgical complications in patients receiving neoadjuvant pembrolizumab (pembro)/ enfortumab vedotin (EV) prior to RNU. EXPLORATORY OBJECTIVE: I. Correlative studies will evaluate the predictive potential of imaging and ureteroscopic response (visualizati…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of high-risk upper tract urothelial carcinoma will be enrolled in this study * Male participants: A male participant must agree to use a contraception during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period * Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the followi…
Interventions
- ProcedureBiopsy
Undergo tissue biopsy
- ProcedureBiospecimen Collection
Undergo blood and urine collection
- DrugEnfortumab Vedotin
Given IV
- ProcedureMR Urography
Undergo MRU
- ProcedureNephroureterectomy
Undergo nephroureterectomy
- BiologicalPembrolizumab
Given IV
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California