A Phase II Trial of Stereotactic Ablative Radiation (SAbR) for Urothelial Cancer Patients With Progression While on Anti-PD-1/PD-L1 Immunotherapy

University of Texas Southwestern Medical Center1 site in 1 country2 target enrollmentJanuary 16, 2020

ConditionsUrothelial Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Urothelial Cancer
Sponsor: University of Texas Southwestern Medical Center
Enrollment: 2
Locations: 1
Primary Endpoint: Progression free survival (PFS) at 6 months
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the benefit of SAbR for oligo-progressive metastatic urothelial cancer.

Detailed Description

Oligo-progressive urothelial cancer with limited disease burden and progression on an anti-PD-1/L1 immune checkpoint inhibitor.

Registry

clinicaltrials.gov

Start Date

January 16, 2020

End Date

June 10, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Texas Southwestern Medical Center

Responsible Party

Principal Investigator

Aurelie Garant

Associate Professor of Medicine

University of Texas Southwestern Medical Center

Eligibility Criteria

Inclusion Criteria

•Patients must be at least 18-years-old
•ECOG performance status 0-2
•Patients must have pathology-proven metastatic urothelial carcinoma, with tissue sampling of at least the primary tumor. Tissue sampling of each presumed metastatic site is not necessary, provided that the patient already has a confirmed diagnosis of urothelial cancer.
•Patients must be on immune checkpoint inhibitor therapy with radiographic scans to verify oligo-progression of at least one and ≤ 6 sites of disease per RECIST 1.
•Any of the currently FDA-approved PD-1/PD-L1 inhibitors are allowed. These include pembrolizumab, nivolumab, atezolizumab, avelumab, and durvalumab.
•At least 1 metastatic lesion must show stable disease, partial response or complete response per RECIST 1.
•Patients must be able to understand and willing to sign written informed consent.
•Patients must have acceptable tolerability of ongoing therapy as decided by the treating medical oncologist.
•Patients must have a desire to continue ongoing therapy.
•Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

Exclusion Criteria

•Inability to receive further immune checkpoint inhibitor therapy
•Anticipated survival of fewer than 12 weeks
•Daily steroid requirement of \> 10 mg prednisone or prednisone-equivalent. Steroid replacement therapy for adrenal insufficiency is permitted.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
•Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Outcomes

Primary Outcomes

Progression free survival (PFS) at 6 months

Time Frame: 6 months

Progression free survival (PFS) at 6 months in the patients for whom SAbR is added to the ICI after progression on ICI. PFS will be defined as the combination of progressive disease from SAbR start date and death from any cause.