drugset / Trial / NCT04936230

Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer

NCT04936230 ↗

Phase 2 Terminated 1 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-11-22
Primary completion
2024-08-15
Completion
2024-08-15

Outcome

Outcome not reported

Stopped (Enrollment): “Inadequate accrual rate”

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody — Intravenous