To evaluate the benefit of SAbR for oligo-progressive metastatic urothelial cancer.
Oligo-progressive urothelial cancer with limited disease burden and progression on an
anti-PD-1/L1 immune checkpoint inhibitor.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||January 16, 2020||Phase 2||Interventional|
Primary Outcome 1 - Measure: Progression free survival (PFS) at 6 months
Primary Outcome 1 - Time Frame: 6 months
- 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
- 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 1.1.
- 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 1.1.
- 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.
- A female of child-bearing potential is any woman (regardless of sexual orientation,
having undergone a tubal ligation, or remaining celibate by choice) who meets the
- Has not undergone a hysterectomy or bilateral oophorectomy, or has not been
naturally postmenopausal for at least 12 consecutive months (i.e., has had menses
at any time in the preceding 12 consecutive months).
- Should a woman become pregnant or suspect she is pregnant while participating in
this study, she should inform her treating physician immediately.
- 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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Aurelie Garant
Role: Principal Investigator
Affiliation: University of Texas Medical Center
Name: Sarah Hardee, MS
Dallas, Texas 75390
Liliana Robles, MS