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Nivolumab with Surgery for Kidney Cancer
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival (EFS)
Secondary outcome measures
Incidence of toxicity
Overall survival
RFS among patients with clear cell cancer
Other outcome measures
Absolute T cell clonotype abundance
Change in T cell repertoire
Change in cytokine levels in patients randomized to the nivolumab arm
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (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 II (nephrectomy)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
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,368 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
66,668 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other similar research projects have been conducted in the past?
"Nivolumab has been under investigation for a decade now, with the first study being sponsored by Medarex back in 2010. Just 127 patients were involved in this initial Phase 1 trial. However, after Nivolumab received drug approval, 749 clinical trials involving the medication have popped up across 50 different nations and 2347 cities."
Answered by AI
Could you please provide a list of other research studies that have used Nivolumab?
"Nivolumab is being studied in 749 ongoing clinical trials, with 82 of them in Phase 3. The majority of the trials for Nivolumab are located in Basel, BE, but there are 40524 locations operating trials for Nivolumab."
Answered by AI
What conditions is Nivolumab usually given to patients suffering from?
"Nivolumab is a medication often used to treat malignant neoplasms. However, Nivolumab has also been found to be helpful in managing other conditions like unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
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