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Keytruda + Yervoy + GM-CSF + Cryosurgical freezing for Cancer
Study Summary
This trial will help researchers learn if the study drug is effective and what side effects it may cause.
- Metastatic Cancer
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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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- The treating investigator may allow some flexibility in these values.You are allergic to Keytruda (pembrolizumab) or any of its ingredients.You have tried all other treatments available for your condition and they have not worked or are not suitable for you.You must agree and sign a paper saying you understand the study and agree to participate.You must be at least 18 years old when you agree to participate.Your doctor thinks you will live for at least 6 more months.You have a mental illness, drug or alcohol addiction, or any other condition that may make it difficult to follow the rules of the trial, according to the doctor in charge.You are allergic to GM-CSF.You have signs of cancer that has spread to other parts of your body according to imaging tests. For prostate cancer patients who have had a PSMA PET scan, only lesions that are seen on both PET scan and CT or MRI will be considered as cancer that has spread.You are currently taking part in another study that involves receiving treatment or have taken part in such a study within 4 weeks of starting this study.You have recently had a stroke or heart attack, or are experiencing heart problems that require medication or treatment.You are able to perform daily activities without significant difficulty.Cancer has spread to your lymph nodes, which will be checked by imaging. Any lymph node that is 1 centimeter or larger will be considered affected by the cancer.It is not known if the study drugs could harm a developing baby. If you participate in this study, you must agree to use reliable birth control before starting the treatment, during the study, and for 120 days after the treatment ends.You have been diagnosed with a solid cancer and you will need to provide your medical records and tissue samples for review by a central laboratory.You have cancer that has spread to your bones, as shown by bone imaging tests. If you had a bone scan or PET scan, it can be used to confirm this. For prostate cancer patients who had PSMA PET, only cancerous lesions will be counted as metastases.
- Group 1: Single arm. Subjects receiving treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 upper limit to the amount of people who can join this clinical trial?
"That is correct. The clinical trial in question, according to the information available on clinicaltrials.gov, is still looking for patients. This specific trial was posted on February 1st 2021 and last updated on February 8th 2021. They are only admitting 32 participants at a single site however."
Are there other examples in which cryosurgery has been used to treat patients?
"At the moment, 1336 studies on non-ablative cryosurgical freezing are ongoing with 160 of those in phase 3. The largest quantity of research is emanating from Houston, Texas; however, there are 56378 clinical trial locations for non-ablative cryosurgical freezing."
Are participants still being sought for this research?
"That is correct. The clinical trial, which was initially posted on February 1st 2021 and edited a week later, is still recruiting patients according to information available on clinicaltrials.gov . They are looking for 32 individuals from 1 location."
What is the long-term safety outlook for Non-ablative Cryosurgical freezing?
"This experimental procedure, known as non-ablative cryosurgical freezing, has only been studied in Phase 2 trials. This means there is evidence suggesting it is safe, but not effective."
What conditions are most often remedied with non-ablative cryosurgical freezing?
"Non-ablative Cryosurgical freezing is a successful treatment method for malignant neoplasms, as well as other diseases like allogenic bone marrow transplantation therapy and microsatellite instability high."
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