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Immunotherapy + Radiation for Cancer
Study Summary
This trial is studying two different ways to give pembrolizumab (with or without stereotactic body radiation therapy) to see how well it works in treating patients with Merkel cell cancer that has spread to other places in the body.
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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- Your blood urea nitrogen level should be less than or equal to 30 mg/dl.Your diastolic blood pressure is less than or equal to 90 mm Hg.I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.I can take care of myself and am up and about more than half of my waking hours.Your body has enough white blood cells called neutrophils.You have a platelet count of at least 100,000 per cubic millimeter.Your total bilirubin level is less than or equal to 2.0 mg/dl.Your albumin levels are higher than 3 mg/dl.I have at least two cancerous areas; one can be measured and one qualifies for a specific radiation treatment.I've had palliative radiotherapy for cancer spread outside the brain but have 2 untreated cancer spots.I've had specific scans to show cancer spread within the last 45 days.I do not have any other cancer that could affect my treatment.Your hemoglobin level is at least 9.0 grams per deciliter.My cancer has spread to distant parts of my body.Your creatinine level in the blood is no higher than 1.7 mg/dl.Your systolic blood pressure is lower than or equal to 150 mm Hg.My diagnosis of Merkel cell carcinoma was confirmed by a pathology review.People with HIV can participate if their CD4 count is 350 mm^3 or higher and their HIV viral load is less than 25,000 IU/ml.Your AST and ALT levels are not more than three times the normal limit.
- 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.
- Group 1: Group I (pembrolizumab)
- Group 2: Group II (pembrolizumab, SBRT)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
What therapeutic applications has Pembrolizumab demonstrated efficacy for?
"Pembrolizumab is recognized for its efficacy in treating malignant neoplasms, unresectable melanoma, and cases of high microsatellite instability."
Are there any establishments conducting this clinical study in North America?
"This clinical trial is being held at Minnesota Oncology Hematology PA-Maplewood in Maplewood, Saint John's Hospital - Healtheast in Lexington, and Saint Joseph Radiation Oncology Resource Center in Ballwin, as well as 100 different other medical sites."
How many participants are currently receiving treatment as part of this clinical research?
"This clinical trial has stopped accepting participants, as the last edit was made on December 3rd 2022. Fortunately, there are still 2484 studies recruiting for Merkel cell carcinoma and 961 for Pembrolizumab."
What prior investigations have included Pembrolizumab as part of the research?
"Currently, 961 clinical trials concerning Pembrolizumab are underway; of that total number, 122 are in the final stage. Most of those tests take place in Houston but there are 36177 other sites carrying out these experiments."
Are researchers presently welcoming new participants for this trial?
"This trial is not presently enrolling new participants. First posted on February 1st, 2018 and most recently updated on December 3rd 2022, it has since ceased its recruitment efforts for the time being. For those seeking alternatives studies involving merkel cell carcinoma there are 2484 clinical trials actively recruiting patients, with 961 of these focusing specifically on Pembrolizumab treatments."
Has the FDA given sanction to Pembrolizumab?
"There is some evidence to suggest that pembrolizumab may be safe, so it was assigned a score of 2. However, there are no clinical findings currently available regarding the efficacy of this medication."
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