30 Participants Needed

Pembrolizumab + Cryoablation for Bladder Cancer

Recruiting at 1 trial location
EW
Overseen ByEric Wehrenberg-Klee, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two treatment combinations for advanced bladder cancer. It targets patients whose cancer has spread. The drugs help the immune system attack cancer cells, and the freezing procedure kills cancer cells directly.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take certain medications like high-dose corticosteroids or anticoagulants that can't be paused before the procedure. It's best to discuss your specific medications with the trial team.

Is the combination of Pembrolizumab and Cryoablation safe for humans?

Pembrolizumab, also known as Keytruda, has been used in various cancer treatments and is generally considered safe, but it can cause side effects like pneumonitis (lung inflammation) and skin reactions. While specific safety data for the combination with cryoablation (a procedure that uses extreme cold to destroy tissue) in bladder cancer is not detailed, pembrolizumab alone has been associated with some immune-related side effects.12345

What makes the treatment with pembrolizumab and cryoablation for bladder cancer unique?

This treatment is unique because it combines pembrolizumab, an immune system-boosting drug, with cryoablation, a technique that freezes and destroys cancer cells, offering a novel approach for bladder cancer that may not respond to standard treatments.14678

What data supports the effectiveness of the treatment Pembrolizumab + Cryoablation for Bladder Cancer?

Pembrolizumab (Keytruda) has been approved by the FDA for treating certain types of bladder cancer, showing effectiveness in patients who did not respond to other treatments. It has been shown to improve survival in advanced bladder cancer and is used when other chemotherapy options are not suitable.1491011

Who Is on the Research Team?

EW

Eric Wehrenberg-Klee, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your blood cell counts, liver function, and kidney function must be within certain limits.
I have a tumor larger than 2 cm that can be treated with cryoablation, and I have more than one metastasis.
I am over 18 and can follow the study's requirements.
See 5 more

Exclusion Criteria

I cannot stop my blood thinner medication before undergoing a freezing procedure.
You can participate in the trial if you have vitiligo or psoriasis that is under control.
I have not had significant infection symptoms in the last 2 weeks.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab or avelumab in combination with cryoablation. Pembrolizumab is administered every 3 weeks and avelumab every 2 weeks, with cryoablation occurring between the 1st and 2nd doses.

up to 2 years
Bi-weekly or tri-weekly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits for up to 2 years.

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cryoablation
  • Pembrolizumab
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab/Avelumab + CryoablationExperimental Treatment3 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Biocompatibles UK Ltd

Industry Sponsor

Trials
25
Recruited
3,300+

Published Research Related to This Trial

Pembrolizumab (Keytruda) has been approved by the FDA for treating high-risk, non-muscle invasive bladder cancer (NMIBC) in patients who are unresponsive to BCG therapy and are either ineligible for or have opted not to undergo cystectomy.
This approval specifically targets patients with carcinoma in situ (CIS) with or without papillary tumors, highlighting its role as a treatment option for those with limited surgical options.
FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC.Wright, KM.[2021]
In a study of 69 patients with advanced urothelial carcinoma who received pembrolizumab after failing platinum-based chemotherapy, the overall response rate (ORR) was 23.2%, indicating some efficacy of the treatment.
The organ-specific response rates varied, with the highest response observed in lung metastases (31.3%) and the lowest in primary tumor sites (7.1%), suggesting that different tumor locations may respond differently to pembrolizumab.
Organ-Specific Tumor Response to Pembrolizumab in Advanced Urothelial Carcinoma After Platinum-Based Chemotherapy.Furubayashi, N., Negishi, T., Sakamoto, N., et al.[2022]
In a study comparing 121 patients treated with pembrolizumab to 67 patients receiving conventional chemotherapy for advanced urothelial carcinoma, pembrolizumab showed a significant improvement in overall survival with a hazard ratio of 0.63, indicating a 37% reduction in the risk of death compared to chemotherapy.
Despite the older age and poorer health status of patients receiving pembrolizumab, the treatment demonstrated a clinical benefit over traditional chemotherapy, suggesting its effectiveness as a second-line therapy in real-world settings.
Comparison of pembrolizumab with conventional chemotherapy after first-line platinum-based chemotherapy for advanced urothelial carcinoma in real-world practice: A multicenter retrospective study.Narita, T., Hatakeyama, S., Numakura, K., et al.[2021]

Citations

FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC. [2021]
Organ-Specific Tumor Response to Pembrolizumab in Advanced Urothelial Carcinoma After Platinum-Based Chemotherapy. [2022]
Comparison of pembrolizumab with conventional chemotherapy after first-line platinum-based chemotherapy for advanced urothelial carcinoma in real-world practice: A multicenter retrospective study. [2021]
Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Urothelial Bladder Carcinoma (PURE-01): An Open-Label, Single-Arm, Phase II Study. [2021]
Pembrolizumab in the treatment of advanced urothelial cancer. [2018]
Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study. [2022]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Immune checkpoint inhibitor lichenoid eruption due to pembrolizumab. [2023]
First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. [2022]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
A case of bronchial asthma as an immune-related adverse event of pembrolizumab treatment for bladder cancer: A case report. [2022]
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