Results for the Phase 2 study (NCT04936230) investigating pembrolizumab with or without radiation therapy for metastatic urothelial cancer were posted on ClinicalTrials.gov on 2025-08-17. The trial, titled 'Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer,' was officially terminated.
Background
This Phase 2 trial aimed to compare the effect of adding radiation therapy to the immunotherapy drug pembrolizumab versus pembrolizumab alone in treating patients with urothelial cancer that had spread to other parts of the body (metastatic). The study's rationale included the hypothesis that adding radiation to immunotherapy might shrink the cancer, though it could also cause side effects. Pembrolizumab, an immunotherapy with monoclonal antibodies, is designed to help the body's immune system attack cancer and interfere with tumor cells' ability to grow and spread.
Trial design
The study (NCT04936230) was a Phase 2 trial with an enrollment of 1 participant. It investigated pembrolizumab as an intervention for patients diagnosed with metastatic urothelial carcinoma, platinum-resistant urothelial carcinoma, and Stage IV bladder cancer AJCC v8. The trial's brief summary indicated it compared immunotherapy with or without radiation therapy.
What this means
The termination of this Phase 2 trial for pembrolizumab in metastatic urothelial cancer means that no efficacy or safety data from this specific study will be generated or reported. With an enrollment of only 1 participant, the study did not progress to a stage where meaningful conclusions could be drawn regarding the comparative effects of pembrolizumab with or without radiation therapy for this patient population. Therefore, this trial will not contribute new clinical insights into the treatment of metastatic urothelial carcinoma.
Source
The information regarding this trial's status was obtained from ClinicalTrials.gov, a public database of clinical studies. The details for study NCT04936230, titled 'Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer,' including its termination status, were posted on 2025-08-17 on clinicaltrials.gov.