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Nivolumab with Surgery for Kidney Cancer (PROSPER Trial)
Phase 3
Waitlist Available
Led By Lauren Harshman
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a renal mass consistent with a clinical stage >= T2Nx renal cell carcinoma (RCC) or TanyN+ RCC for which radical or partial nephrectomy is planned
Patients must not have any prior systemic or local anti-cancer therapy for the current RCC
Must not have
Patient must not have received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Patient must be >= 18 years of age. Because no dosing or adverse event data are currently available on the use of nivolumab therapy in patients < 18 years of age, children are excluded from this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, pre-nephrectomy, 8 weeks post-nephrectomy, 20 weeks, 40 weeks, 54 weeks, recurrence and 2 years post randomization
Awards & highlights
Summary
This trial is testing whether nephrectomy plus nivolumab is better than nephrectomy alone at treating patients with localized kidney cancer.
Who is the study for?
Adults with localized kidney cancer (stage T2 or higher, without distant metastases) who are planning to have a kidney removed and haven't had prior cancer treatments. Participants should not have serious illnesses, active infections needing IV antibiotics, HIV, or be on high-dose steroids. They must not be pregnant/breastfeeding and agree to use contraception.
What is being tested?
The trial is testing if adding the drug Nivolumab after removing part or all of a kidney can prevent cancer from returning better than just surgery alone. Nivolumab boosts the immune system's ability to fight remaining cancer cells post-surgery.
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), liver issues, and could potentially worsen pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for kidney surgery due to a large tumor or one that has spread to lymph nodes.
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I have not received any treatment for my current kidney cancer.
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I have not been treated for kidney cancer with the aim of cure in the last 5 years.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I do not have a serious illness or an active infection needing IV antibiotics.
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I have not had any major surgery in the last 28 days.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not been treated with specific immune system targeting drugs.
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I am 18 years old or older.
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My cancer has not spread to my liver, bones, or brain.
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I have not had a partial kidney removal for my kidney cancer.
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I have not received any cancer treatment for kidney cancer.
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I have up to 3 cancer spread sites that can be treated within 3 months after my main tumor is removed.
Select...
My biopsy after joining the study did not show renal cell carcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline, pre-nephrectomy, 8 weeks post-nephrectomy, 20 weeks, 40 weeks, 54 weeks, recurrence and 2 years post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, pre-nephrectomy, 8 weeks post-nephrectomy, 20 weeks, 40 weeks, 54 weeks, recurrence and 2 years post randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recurrence-free Survival (RFS) Rate at 5 Years
Secondary study objectives
Overall Survival Rate at 5 Years
Recurrence-free Survival (RFS) Rate at 3 Years Among Patients With Clear Cell Histology
Other study objectives
Association Between the Expression of PD-L1 on Tumor Tissue at Nephrectomy as Well as Recurrence and Outcome
Association Between the Primary Tumor's Expression of PD-L1 With Outcome
To Archive Images for Potential Central Confirmation of Recurrence and for Future Correlative Work
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (nivolumab + nephrectomy)Experimental Treatment4 Interventions
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab over 30 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Patients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (nephrectomy only)Active Control4 Interventions
Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nephrectomy
2013
Completed Phase 3
~1430
Nivolumab
2014
Completed Phase 3
~5220
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,181 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
127 Previous Clinical Trials
67,455 Total Patients Enrolled
Lauren HarshmanPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been treated with specific immune system targeting drugs.I am 18 years old or older.I had surgery or thermal ablation for a kidney tumor smaller than 3 cm.I am scheduled for kidney surgery due to a large tumor or one that has spread to lymph nodes.Your blood platelet count is at least 100,000 per cubic millimeter within 8 weeks before joining the study.Your total bilirubin level should be less than 1.5 times the upper limit of normal, unless you have Gilbert syndrome, in which case it can be less than 3 times the upper limit of normal.Your liver enzymes (AST and ALT) are not more than 2.5 times the normal level.I can understand and am willing to sign the consent form.I have no signs of cancer spread, or if present, it will be treated to aim for no evidence of disease.My cancer has not spread to my liver, bones, or brain.I have not had a partial kidney removal for my kidney cancer.I agree to a biopsy if I haven't had one in the last year and am assigned to Arm A.I have not received any treatment for my current kidney cancer.I have not been treated for kidney cancer with the aim of cure in the last 5 years.I am fully active or restricted in physically strenuous activity but can do light work.I have no other cancers except for certain low-risk types or those in remission for 3+ years.I do not have an active autoimmune disease, except for allowed conditions like vitiligo or stable thyroid issues.I have kidney cancer in both kidneys but can be treated without removing both completely.I do not have a serious illness or an active infection needing IV antibiotics.I don't have chronic liver disease or hepatitis B or C.I have not had any major surgery in the last 28 days.I am not on high-dose steroids or other immune-weakening drugs, except for certain conditions.I am not pregnant or breastfeeding and have confirmed this with a test within the last 2 weeks.My kidney function, measured by creatinine levels, is within the normal range.You should not have HIV infection. If there is a suspicion, you will need to get tested.I had kidney cancer treated over 5 years ago, and my current cancer is considered new.You have not had a serious allergic reaction to a specific type of medication called a monoclonal antibody.Your white blood cell count is at least 1,500 per cubic millimeter.Your white blood cell count is at least 2000 cells per microliter within the 8 weeks before joining the study.My kidney cancer biopsy shows it's RCC, including if the type wasn't clear.Your hemoglobin level is at least 9.0 grams per deciliter within the 8 weeks before starting the study.I have not received any cancer treatment for kidney cancer.I haven't had surgery to remove cancer spread unless it was to clear all signs of cancer, along with kidney removal.I have up to 3 cancer spread sites that can be treated within 3 months after my main tumor is removed.My biopsy after joining the study did not show renal cell carcinoma.
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