Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04701918
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2020-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cryoablation With Pembrolizumab Or Avelumab In Urothelial Carcinoma
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Multicenter, Single-Arm Open Label Phase II Trial of Cryoablation in Combination With Pembrolizumab or Avelumab in Patients With Metastatic Urothelial Carcinoma
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is examining the effectiveness of pembrolizumab plus cryoablation or aveluma plus cryoablation on people with urothelial carcinoma, including bladder cancer, that has spread.
Detailed Description:
This is an open label Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of pembrolizumab and cryoablation or avelumab 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, pembrolizumab, and avelumab as treatment options for urothelial carcinoma, including bladder cancer, that has spread. However, the FDA has not yet approved the combination of the drugs, pembrolizumab or avelumab, 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. Avelumab is believed to work by binding a similar molecule called PD-L1. 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.
The U.S. Food and Drug Administration (FDA) has approved both cryoablation, pembrolizumab, and avelumab as treatment options for urothelial carcinoma, including bladder cancer, that has spread. However, the FDA has not yet approved the combination of the drugs, pembrolizumab or avelumab, 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. Avelumab is believed to work by binding a similar molecule called PD-L1. 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: