drugset / Trial / NCT04628767

Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

NCT04628767

Phase 2/3 Recruiting 131 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

Timeline

Start
2021-11-12
Primary completion
2027-09-30
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified Intravenous
Subject Doxorubicin Other / unclassified Intravenous
Subject Durvalumab Monoclonal antibody Intravenous
Subject Gemcitabine Small molecule Intravenous
Subject Methotrexate Small molecule Intravenous
Subject Vinblastine Small molecule Intravenous
Background Pegfilgrastim Protein / enzyme biologic Other