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Pembrolizumab + Cryoablation for Bladder Cancer
Study Summary
This trial is testing if adding pembrolizumab to cryoablation improves outcomes for people with urothelial carcinoma that has spread.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- Your blood cell counts, liver function, and kidney function must be within certain limits.I cannot stop my blood thinner medication before undergoing a freezing procedure.I have a tumor larger than 2 cm that can be treated with cryoablation, and I have more than one metastasis.You can participate in the trial if you have vitiligo or psoriasis that is under control.I am over 18 and can follow the study's requirements.I have not had significant infection symptoms in the last 2 weeks.I have an autoimmune thyroid condition but am stable on my medication.I have lasting side effects from chemotherapy, but not hair loss.You have a weakened immune system due to a serious illness like HIV/AIDS, or your blood CD4+ T cell count is less than 200 per microliter.I have taken low-dose steroids for nausea or before a contrast agent.I haven't taken any immune-boosting drugs in the last 6 weeks.I haven't had any cancer treatments in the last 4 weeks and have recovered from side effects.My cancer, found in parts of my urinary system, has spread to other areas.I haven't taken high doses of steroids or immunosuppressants recently.I do not have any health conditions that could interfere with the study treatment.I have a history of autoimmune disease.I have Type 1 diabetes managed with a stable insulin dose.I have previously been treated with immune therapy drugs.I cannot lie flat for a medical procedure.My lesion for cryoablation has not received prior radiation or local treatments.You have had serious allergic reactions to certain types of medications in the past.I am fully active or restricted in physically strenuous activity but can do light work.
- Group 1: Pembrolizumab/Avelumab + Cryoablation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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