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Belzutifan + Pembrolizumab for Kidney Cancer
Study Summary
This trial is testing a new drug to see if it can help prevent ccRCC from coming back after surgery.
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.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have received treatment for kidney cancer before.I need extra oxygen sometimes or all the time.My cancer has spread to my brain or bones.I have not had major surgery in the last 4 weeks, except for kidney removal or removal of cancer spread.I have had radiation therapy for kidney cancer.I will continue using birth control for at least 7 days after my last dose.I am fully active or restricted in physically strenuous activity but can do light work.I have an autoimmune disease treated in the last 2 years, except for hormone replacement.I have had serious heart problems in the last 6 months.I have an immune system disorder or am on long-term steroids.My organs are functioning well.I have another cancer besides kidney cancer that has been active or treated in the last 3 years.I have received an organ or tissue transplant from another person.My kidney cancer is at an intermediate-high, high risk, or I have no signs of cancer after it spread.It seems like there might be a typo or incomplete sentence here. Can you please provide more context or clarify the criterion you'd like to have rewritten?I do not have serious wounds, ulcers, fractures, or need dialysis.I have or had lung inflammation that needed steroids.I have kidney cancer with limited spread that can be surgically removed.I had surgery to remove a kidney or cancer spread within the last 12 weeks.I had surgery to remove my primary cancer and any isolated spread.I am currently being treated for an infection.I agree to use birth control during and up to 120 days after the study.I have a history of HIV or Hepatitis B/C.My organs are functioning well.I have kidney cancer with treatable metastases either at the same time as or within 2 years after my kidney removal.I had surgery to remove a kidney or cancer spread within the last 12 weeks.I have not received a live vaccine within the last 30 days.My kidney cancer diagnosis includes clear cell characteristics.
- Group 1: Placebo + Pembrolizumab
- Group 2: Belzutifan + Pembrolizumab
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
How many people suffering from this disease will be given the chance to try this new treatment?
"Yes, according to the latest information available on clinicaltrials.gov, this study is still recruiting patients. The trial was first posted on March 15th, 2022 and last updated November 11th, 2022. So far, 31 different centres have enrolled 1600 participants in total."
Has Pembrolizumab received clearance from the FDA?
"Pembrolizumab has received a score of 3 for safety by our team at Power. Phase 3 trials have some data supporting efficacy and multiple rounds of data supporting safety."
Are there any vacancies in this trial for new participants?
"That is correct. The information available on clinicaltrials.gov does show that the trial is still recruiting patients. It was initially posted on March 15th, 2022 and was last updated November 11th, 2022. Currently, they are looking for 1600 people to participate at 31 different sites."
Are there any hospitals or clinics in North America conducting this research?
"31 locations are currently running this clinical trial, some notable ones being The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C in Columbus, Dana-Farber Cancer Institute-GU ( Site 3505) in Boston, and Sanford Cancer Center ( Site 3551) in Sioux Falls."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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