Infiltrating Bladder Urothelial Carcinoma Clinical Trial
Official title:
A Phase II Study of Radiation Therapy and Pembrolizumab in Patients With Localized Urothelial Bladder Cancer That Are Ineligible or Refusing Chemotherapy
This randomized phase II trial studies how well radiation therapy and pembrolizumab work in treating patients with urothelial bladder cancer that is restricted to the site of origin, without evidence of spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy and pembrolizumab may work better in treating urothelial bladder cancer.
PRIMARY OBJECTIVES:
I. To determine the maximally tolerated doses of hypofractionated and conventionally
fractionated radiation therapy in combination with pembrolizumab and to generate an estimate
of the efficacy of this regimen. (Safety Lead-in) II. To estimate the clinical complete
response (CR) rate of the primary irradiated tumor in patients receiving radiotherapy and
pembrolizumab. (Dose Expansion Cohort)
SECONDARY OBJECTIVES:
I. To estimate the local control rate at 6 and 12 months in each study arm. II. To estimate
the distant metastases free survival at 6 and 12 months in each study arm.
III. To estimate progression free survival at 6 and 12 months in each study arm.
IV. To estimate disease-specific survival at 6 and 12 months in each study arm. V. To
determine the safety of combining radiotherapy with pembrolizumab in each study arm in the
dose expansion phase.
TERTIARY OBJECTIVES:
I. To assess peripheral and tumor-based biomarkers of response and resistance. II. To define
the treatment-induced effects on circulating immune cells. III. To explore the remodeling of
circulating T cell repertoire.
OUTLINE: Patients are randomized to 1 of 2 cohorts.
COHORT I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1.
Treatment repeats every 3 weeks for up to 13 courses in the absence of disease progression or
unacceptable toxicity. Patients also receive hypofractionated radiation therapy (RT) over 5
fractions for 14 days.
COHORT II: Patients receive pembrolizumab as in Cohort I. Patients also receive
conventionally fractionated RT over 30 fractions for 52 weeks.
After completion of study treatment, patients are followed up at 30 days and then every 12
weeks for up to 24 months.
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