Trial results for the Phase 2 study (NCT02621151) investigating pembrolizumab, gemcitabine, and concurrent hypofractionated radiation therapy for muscle-invasive urothelial cancer of the bladder were posted on ClinicalTrials.gov on 2025-10-07. The study reported a 60% two-year bladder-intact disease-free survival rate and a 56% complete response rate.
Background
This trial assessed the efficacy of pembrolizumab (MK3475) added to concurrent radiation and gemcitabine in the management of patients with muscle-invasive urothelial cancer who are not candidates for or decline radical cystectomy.
Trial design
The study (NCT02621151) was a Phase 2 trial that enrolled 60 participants. It investigated the combination of pembrolizumab and gemcitabine with concurrent hypofractionated radiation therapy for patients with muscle-invasive urothelial cancer of the bladder.
Key results
The trial reported several key outcomes for the combination of pembrolizumab, gemcitabine, and radiation therapy:
- Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival: 60 percentage of participants (95% Confidence Interval: not provided).
- Complete Response (CR) Rate: 56 percentage of participants.
- Percentage of Participants Who Survived at Study Completion: 83 percentage of participants (95% Confidence Interval: not provided).
- Percentage of Participants Who Achieved Metastasis-free Survival at Study Completion: 84 percentage of participants (95% Confidence Interval: not provided).
What this means
The results from this Phase 2 trial suggest that the combination of pembrolizumab, gemcitabine, and concurrent hypofractionated radiation therapy may offer a viable bladder-sparing treatment option for patients with muscle-invasive urothelial cancer of the bladder who are not candidates for or decline radical cystectomy. The reported 60% two-year bladder-intact disease-free survival rate and 56% complete response rate indicate potential efficacy for this regimen.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02621151, titled 'Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder,' were posted on 2025-10-07 on clinicaltrials.gov.