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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have primary tumor in place
Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease: Computed tomography (CT) scan of the chest, CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast. Scans must be performed within specific timeframes based on treatment history
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 7 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
PROBE Trial Summary
This trial will compare immunotherapy plus surgery to immunotherapy alone to see if it is more effective in treating kidney cancer.
Eligible Conditions
- Renal Cell Carcinoma
- Kidney Cancer
PROBE Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You must have the original tumor in its original location.
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You need to have specific scans done within a certain timeframe that show evidence of cancer spreading to other parts of the body.
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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.
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Your recent lab test results need to meet specific requirements.
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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.
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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.
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You have received at least a certain amount of a specific type of immunotherapy.
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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.
PROBE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Change in maximum diameter of primary tumor
Objective response
Overall survival in subset who received assigned protocol treatment
+1 moreAwards & Highlights
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.
PROBE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Nephrectomy and Continued Systemic TherapyExperimental Treatment1 Intervention
Continued systemic therapy as above, plus:
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization.
Group II: Arm 1: Continued Systemic Therapy OnlyActive Control2 Interventions
Nivolumab 240 mg IV 1 q 2 weeks
OR
Nivolumab 480 mg IV 1 q 4 weeks
OR
Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID
OR
Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
262,429 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
393 Previous Clinical Trials
265,538 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,490 Previous Clinical Trials
41,266,351 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Continued Systemic Therapy Only
- Group 2: Arm 2: Nephrectomy and Continued Systemic Therapy
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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