Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer (SAbR)

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Urothelial Cancer

Treatments: Radiation: Stereotactic Ablative Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT04131634

2019-1506

Details and patient eligibility

About

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

Full description

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

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

SAbR 6 measurable lesions

Experimental group

Description:

PD-L1 assessment on biopsy of metastatic site (biopsy will be performed if no prior metastasis sample available)

Treatment:

Radiation: Stereotactic Ablative Radiation