Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Aditya Bagrodia (ucsd)

Description

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.

Official Title

A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Details

Keywords

Renal Pelvis and Ureter Urothelial Carcinoma, Cisplatin, Gemcitabine, Doxorubicin, Liposomal doxorubicin, Methotrexate, Durvalumab, Vinblastine, Lenograstim, Immunoglobulins, Monoclonal Antibodies, Immunoglobulin G, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Doxorubicin Hydrochloride, Gemcitabine Hydrochloride, Magnetic Resonance Imaging, Pegfilgrastim, Vinblastine Sulfate, durvalumab, chemotherapy, chemotherapy, durvalumab, gemcitabine hydrochloride

Eligibility

Locations

Lead Scientist at University of California Health

  • Aditya Bagrodia (ucsd)
    Professor, Urology, Vc-health Sciences-schools. Authored (or co-authored) 266 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT04628767
Phase
Phase 2/3 Transitional Cell Carcinoma Research Study
Study Type
Interventional
Participants
Expecting 249 study participants
Last Updated