Pembrolizumab And Cryoablation In Urothelial Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bladder Cancer
- Metastatic Urothelial Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an open label Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of pembrolizumab and cryoablation on people with urothelial carcinoma, including bladder cancer, that has spread. The U.S. Food and Drug Administration (FDA) has approved both cryoablation...
This is an open label Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of pembrolizumab and cryoablation on people with urothelial carcinoma, including bladder cancer, that has spread. The U.S. Food and Drug Administration (FDA) has approved both cryoablation and pembrolizumab as a treatment option for urothelial carcinoma, including bladder cancer, that has spread. However, the FDA has not yet approved the combination of the drug, pembrolizumab, and intervention, cryoablation, for urothelial carcinoma, including bladder cancer, that has spread. Pembrolizumab is believed to work by binding to a chemical called PD-1 that is found on a special type of white blood cell in your body. This may help your body to be better at finding and destroying tumor cells. Cryoablation is an intervention which may kill cancer cells using extreme cold. It may help the immune system better recognize tumors and act against it. The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits. Participants will receive study treatment as long as their disease does not get worse or they do not have any unacceptable side effects for up to two years. Participants will be followed for up to 2 years after ending the study treatment. It is expected that about 30 people will take part in this research study. Biocompatibles UK Ltd, a device company under Boston Scientific, is supporting this research study by providing funding for the needles used in the study intervention.
Tracking Information
- NCT #
- NCT04701918
- Collaborators
- Biocompatibles UK Ltd
- Investigators
- Principal Investigator: Eric Wehrenberg-Klee, MD Massachusetts General Hospital