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

Short Title: EA8192

Enrollment Status: Recruiting

NCT #: NCT04628767

Specialty Area: Oncology

Condition Studied: Urothelial Carcinoma

Age Groups: Adult; Older Adult

Phase: II/III

Study Information

Summary / Purpose

The purpose of this study is to compare a usual treatment alone to using Durvalumab plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach.

Study Type: Interventional

Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:

Adults 18+ years of age
Diagnosis of high grade upper tract urothelial carcinoma
No small cell/neuroendocrine carcinoma
No evidence of metastatic disease or clinically enlarged regional lymph nodes

What's Involved

Participation in the study will include:

Assignment to one of three groups based on whether you are able to receive the chemotherapy drug cisplatin; those who can are randomly assigned to chemotherapy alone or chemotherapy plus the immunotherapy drug durvalumab given intravenously
Chemotherapy given through a vein before surgery, which may include methotrexate, vinblastine, doxorubicin, cisplatin, or gemcitabine depending on your group
Pegfilgrastim given by injection to support your blood counts during chemotherapy
Surgery to remove the kidney and ureter after chemotherapy
A tissue biopsy
Blood sample collection
Imaging scans with computed tomography (CT) and magnetic resonance imaging (MRI)

Principal Investigator

Parth Sampat, MD

Hematology - Oncology

(775) 982–2820

Renown Hematology/Oncology

View Provider

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT04628767

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.