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PROBE Trial Summary
This trial will compare immunotherapy plus surgery to immunotherapy alone to see if it is more effective in treating kidney cancer.
- Renal Cell Carcinoma
- Kidney Cancer
PROBE Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
PROBE Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
PROBE Trial Design
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Who is running the clinical trial?
- and at Baseline
People who have received treatment before must have scans documenting metastatic disease within 90 days before their first dose of systemic treatment and at the time of the study's baseline.People who have metastases that cause symptoms may have received palliative radiotherapy before they registered for the study, or they may receive palliative radiotherapy after they have registered for the study.(STS)
Participants must be offered the opportunity to participate in specimen bankingYou need to have specific scans done within a certain timeframe that show evidence of cancer spreading to other parts of the body.If you have cancer that has spread and you are experiencing symptoms, you may have had or will receive radiotherapy to help with those symptoms.If you haven't had treatment for your condition before, you need to have had scans showing the spread of the disease within the last 90 days before joining the study.You need to have a confirmed diagnosis of a specific type of kidney cancer, but not a different type called collecting duct carcinoma. If you have more than one tumor in your kidneys, you can still participate.You must have clear cell or non-clear cell renal cell carcinoma, but not collecting duct carcinoma. If you have tumors in more than one place or on both sides, you can still participate.You must have the original tumor in its original location.Your recent lab test results need to meet specific requirements.You should not have active brain tumors. If you had brain tumors before but don't have any symptoms now, you may still be eligible.You have not been treated with certain medications for metastatic kidney cancer in the past.You do not have a medical condition that prevents you from receiving immune-based combination therapy or nephrectomy.Your primary tumor should not be getting worse, unless it's just a temporary increase that looks like progression but isn't.You need to have certain scans done 12 weeks after starting treatment to see how well it's working. If the scans show that all the cancer has disappeared, you can't take part in the next part of the study.After 12 weeks of treatment before randomization, your disease should be stable or have shown partial response. Your doctor must also believe that you are benefiting from the treatment and your overall physical condition should be good.You have received at least a certain amount of a specific type of immunotherapy.Your total bilirubin level should not be higher than the normal range set by the hospital within the 28 days before being chosen for the study.Your liver function tests must be within a certain range before you can join the study.Your kidney function test must show that your kidneys are working well, and the test should have been done within the last 28 days before you join the study.
- Group 1: Arm 1: Continued Systemic Therapy Only
- Group 2: Arm 2: Nephrectomy and Continued Systemic Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 locations are participating in this research?
"There are 100 hospitals participating in this trial, with locations such as Marshfield Medical Center-Marshfield, The Carle Foundation Hospital and Marshfield Clinic - Ladysmith Center."
Are people still being allowed to sign up for this experiment?
"The clinical trial is currently looking for patients, as indicated by the information on clinicaltrials.gov. This research was initially posted on 11/16/2020 and was edited most recently on 11/9/2022. The study plans to enroll 364 participants from 100 sites in total."
How many individuals are being included in this experiment?
"To successfully conduct this trial, 364 individuals that meet the pre-determined inclusion criteria must enroll. These patients can come from many places, but two example locations are Marshfield Medical Center-Marshfield in Marshfield, Illinois and The Carle Foundation Hospital in Urbana, Minnesota, Illinois and The Carle Foundation Hospital in Urbana, Minnesota."
Has the FDA cleared Cytoreductive Nephrectomy for use?
"Cytoreductive Nephrectomy received a score of 3 due to the presence of data supporting its efficacy and safety from multiple sources."
Who else is applying?
What portion of applicants met pre-screening criteria?
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