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BRIEF TITLE: Stereotactic Ablative Radiation (SAbR) for Urothelial Cancer Patients With Progression While on Anti-PD-1/PD-L1 Immunotherapy

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


  • Org Study ID: 2019-1506
  • Secondary ID:
  • NCT ID: NCT04131634
  • NCT Alias:
  • Sponsor: University of Texas Southwestern Medical Center - Other
  • Source: University of Texas Southwestern Medical Center

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.

Overal Status Start Date Phase Study Type
Recruiting January 16, 2020 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Progression free survival (PFS) at 6 months

Primary Outcome 1 - Time Frame: 6 months

Condition:

  • Urothelial Cancer

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 1.1.

- 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
following criteria:

- 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.

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Aurelie Garant

Role: Principal Investigator

Affiliation: University of Texas Medical Center

Overall Contact

Name: Sarah Hardee, MS

Phone: 2146458525

Email: sarah.hardee@utsouthwestern.edu

Location

Facility Status Contact
Aurelie Garant
Dallas, Texas 75390
United States
Recruiting Liliana Robles, MS
214-645-8525