Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer

Conditions

• Metastatic Urothelial Carcinoma
• Platinum-Resistant Urothelial Carcinoma
• Stage IV Bladder Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo urine and blood sample collection
• Bone Scan — PROCEDURE
  Undergo bone scan
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Pembrolizumab — BIOLOGICAL
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET scan
• Questionnaire Administration — OTHER
  Ancillary studies
• Stereotactic Body Radiation Therapy — RADIATION
  Undergo SBRT

Study Details

This phase II trial compares the effect of adding radiation therapy to an immunotherapy drug called pembrolizumab versus pembrolizumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The addition of radiation to immunotherapy may shrink the cancer, but it could also cause side effects. Immunotherapy with monoclonal antibodies such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. The combination of pembrolizumab and radiation therapy may be more efficient in killing tumor cells.

Key Dates

Start date

Nov 22, 2022

Status verified

Aug 2025

Primary completion

Aug 15, 2024

Completion

Aug 15, 2024

Study Design

Enrollment

1 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (pembrolizumab)
  Patients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan and/or PET scan, as well as optional urine and blood sample collection throughout the study.
• Experimental: Arm B (pembrolizumab, SBRT)
  Patients receive pembrolizumab as in Arm A. Patients also undergo SBRT QD every other day for 3 fractions over 2 weeks that must be completed before 12 weeks after the first dose of pembrolizumab in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan, and/or PET scan, as well as optional urine and blood sample collection throughout the study.

Primary Outcome Measure

Tumor Response [ Time Frame: Up to 6 months from randomization ]

Locations (83)

Related coverage on Hipa.ai

• Pembrolizumab Trial for Metastatic Urothelial Cancer Terminated
  Pembrolizumab · Aug 17, 2025 · ClinicalTrials.gov

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