Adj Sacituzumab Govitecan+Nivolumab in Pts w/ Muscle-Invasive Urothelial Ca at High-Risk Recurrence

UCI Specialty Area: Cancer

Principal Investigator: Nataliya Mar

Official Title: Adjuvant Sacituzumab Govitecan Plus Nivolumab in ctDNA Positive Patients with Muscle-Invasive Urothelial Carcinoma at High-Risk for Recurrence

A Study On:

Other Urinary

Urinary Bladder

Study Description

This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology.

Eligibility

You can participate in this study if you satisfy the following criteria:

At least 18 years of age
Confirmed diagnosis of muscle-invasive urothelial cancer of the bladder, ureter, or kidney
Had surgery to remove the urinary bladder or kidney with ureter to treat urothelial cancer of the bladder, ureter, or kidney
Considered to be at high risk of cancer coming back based on amount of cancer seen during surgery
May have had chemotherapy prior to surgery
Able and willing to provide informed consent

You cannot participate in this study if you any of the following criteria:

Cancer that has spread to other parts of the body.
Any active diseases of the immune system
Pregnant or nursing
Any other type of cancer besides urothelial cancer that was present in the last three years before joining the study.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

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