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Checkpoint Inhibitor

Pembrolizumab + Cryoablation for Bladder Cancer

Phase 2
Recruiting
Led By Eric Wehrenberg-Klee, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable metastatic disease with at least one site of metastatic disease > 2 cm in size and amenable to percutaneous image-guided cryoablation based on routine Interventional Radiology criteria. Metastasis sites amenable to cryoablation to include lymph node, peritoneum, liver, soft tissue, adrenal glands, kidney, lung, and bone. Must have measurable disease (by RECIST v1.1) independent of the lesion to be ablated (ie patient must have more than one metastasis)
Age > 18 years at date of ICF signature having the ability to comply with the protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing if adding pembrolizumab to cryoablation improves outcomes for people with urothelial carcinoma that has spread.

Who is the study for?
Adults over 18 with metastatic urothelial carcinoma, including bladder cancer, who have measurable disease and are in good enough health for the treatment. They must not have had certain autoimmune diseases or recent immunosuppressive treatments, no prior immune checkpoint therapies, and should be able to lie flat for cryoablation.Check my eligibility
What is being tested?
The trial is testing the combination of pembrolizumab (an immunotherapy drug) with cryoablation (a procedure that freezes cancer cells) on patients whose bladder cancer has spread to see if it's effective.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects like inflammation in organs, skin reactions, hormone gland problems (like thyroid), and infusion reactions. Cryoablation can cause pain at the site of treatment, bleeding, infection risk increase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor larger than 2 cm that can be treated with cryoablation, and I have more than one metastasis.
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I am over 18 and can follow the study's requirements.
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My cancer, found in parts of my urinary system, has spread to other areas.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate
Secondary outcome measures
Duration of response (DOR)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Overall survival (OS)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab/Avelumab + CryoablationExperimental Treatment3 Interventions
If patient is receiving pembrolizumab: Participants will be given 200 mg pembrolizumab intravenously once every 3 weeks. This will continue for up to 2 years as per standard of care. Participants will receive cryoablation between the 1st and 2nd doses of pembrolizumab. Cryoablation consists of using a CT scan to guide one or more thin needles to the tumor through your skin, where extreme cold is applied. If patient is receiving avelumab: Participants will be given 800 mg avelumab intravenously once every 2 weeks. This will continue for up to 2 years as per standard of care. Participants will receive cryoablation between the 1st and 2nd doses of avelumab. Cryoablation consists of using a CT scan to guide one or more thin needles to the tumor through your skin, where extreme cold is applied.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Pembrolizumab
2017
Completed Phase 2
~2010
Cryoablation
2016
Completed Phase 2
~1040

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,393 Total Patients Enrolled
Biocompatibles UK LtdIndustry Sponsor
24 Previous Clinical Trials
2,499 Total Patients Enrolled
Eric Wehrenberg-Klee, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04701918 — Phase 2
Bladder Cancer Research Study Groups: Pembrolizumab/Avelumab + Cryoablation
Bladder Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04701918 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04701918 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the FDA's ruling on Pembrolizumab?

"Pembrolizumab received a safety score of 2 because, while there is evidence that it is safe, Phase 2 trials have not yet collected data to support efficacy."

Answered by AI

Are people currently being recruited for this research project?

"That is correct, the clinicaltrials.gov website currently lists this study as open for recruitment. This particular trial was first advertised on June 4th 2021 and was last updated October 27th 2021. The study requires 30 patients to be enrolled at 2 different locations."

Answered by AI

How many people total are allowed to enroll in this experiment?

"The clinicaltrials.gov website contains information revealing that this study is looking for enrollees. This trial was first posted on June 4th, 2021 and updated most recently on October 27th, 2021. They are hoping to find 30 participants who will visit the two locations involved in the research."

Answered by AI

What are some of the most common reasons why Pembrolizumab is given to patients?

"Pembrolizumab is frequently used to treat patients with malignant neoplasms. Other conditions that this medication can be effective against include unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

Could you please outline the Pembrolizumab research that has been conducted thus far?

"As of now, there are 1000 ongoing clinical trials for the cancer medication Pembrolizumab. Out of these, 122 are in Phase 3. The majority of locations where these trials are taking place is Houston, Texas; however, there are 36027 different centres running Pembrolizumab trials in total."

Answered by AI
~6 spots leftby Dec 2024