Active not recruitingPHASE3INTERVENTIONAL

Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

This important study is comparing two ways to treat kidney cancer that is still contained within the kidney, called 'localized kidney cancer'. Some patients will have surgery to remove part or all of their kidney, which is the usual treatment. Other patients will have the same surgery but also receive a new drug called nivolumab. Nivolumab is designed to help your body's own immune system fight off any remaining cancer cells. The main goal is to find out if adding nivolumab after surgery can prevent the cancer from returning, compared to surgery alone. Researchers will also look at how long people live, the safety of nivolumab, and how it affects patients' quality of life. This is a crucial step in understanding if nivolumab could offer a better chance of staying cancer-free for people with kidney cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

National Cancer Institute (NCI)

Enrolment target

819

Start

28 Apr 2017

Estimated completion

09 Jun 2031

Metastatic Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Stage II Renal Cell Cancer AJCC v7 Stage III Renal Cell Cancer AJCC v7 Unclassified Renal Cell Carcinoma

Results

Results from this study

Posted April 2024

Results have been published for this study.

Primary outcome

Recurrence-free Survival (RFS) Rate at 5 Years

RFS is defined as time from randomization to disease recurrence or death from any cause. Patients who did not undergo nephrectomy or were not disease-free following nephrectomy were considered as having an event at day 1. Patients that are alive without an event were censored at the date of last disease evaluation. RFS rate at 5 years was the proportion of patients who are recurrence-free and alive at 5 years based on Kaplan-Meier estimates.

Full results on the registry

What is this study about?

When you have kidney cancer that hasn't spread to other parts of your body, the main treatment is often surgery to remove the affected part or the whole kidney. This study is exploring whether a new drug, nivolumab, can improve the chances of the cancer not coming back after this surgery.

Nivolumab is a type of medicine called immunotherapy. It works by helping your body's immune system – your natural defence against illness – to recognise and fight cancer cells. The idea is that even after surgery, tiny cancer cells might remain, and nivolumab could help your immune system find and destroy them, potentially stopping the cancer from returning.

This study will compare two groups of patients. One group will have the standard surgery followed by regular check-ups. The other group will have the same surgery but will also receive nivolumab for a short period before and/or after their operation. Researchers will carefully monitor both groups to see if nivolumab makes a difference in preventing the cancer from coming back, how safe it is, and how it affects patients' well-being.

Key takeaways

This study is testing nivolumab with surgery for kidney cancer that hasn't spread.
Nivolumab is an immunotherapy that aims to help your immune system fight cancer.
The main goal is to see if nivolumab can stop cancer from returning after surgery.
You'll be randomly assigned to either receive nivolumab plus surgery, or surgery alone.
Participants will have regular check-ups and provide information on their well-being.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would typically have kidney cancer that your doctors believe is still contained within the kidney area, not having spread to distant parts of your body. However, if you have a very small number of spots that might be cancer that has spread, these would need to be removable at the same time or soon after your kidney surgery.

You cannot have had any previous treatment for your current kidney cancer, such as chemotherapy or radiation, and you won't be able to join if you've already had a partial kidney removal for this cancer. Doctors will also need to confirm the type of kidney cancer you have, potentially through a biopsy if one hasn't been done recently.

Generally, you need to be 18 years or older. This study is for both men and women. The medical team would review your full health history to ensure it's safe and appropriate for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have kidney cancer that doctors believe hasn't spread far.
I haven't had previous cancer treatment for this kidney cancer.
I am aged 18 or older.
I am planning to have surgery for my kidney cancer.
I am well enough to potentially receive additional medication.

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly placed into one of two groups. One group will receive the standard kidney surgery. The other group will have the same kidney surgery, but will also have nivolumab given into a vein before and/or after their operation. Each nivolumab treatment takes about 30 minutes, usually every two weeks for a couple of cycles before surgery, and then for about a year after surgery.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You'll also be asked to complete questionnaires about your symptoms and how you're feeling, which helps researchers understand your quality of life. The total duration of active treatment with nivolumab is typically about a year, but you'll be followed up for several years after that to track your progress.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical attention and potentially receive a new treatment that could reduce the chance of your cancer returning, although this is not guaranteed. However, nivolumab can have side effects, as it works with your immune system, and your medical team will monitor you closely for these. The risks of surgery are the same as if you weren't in the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (413)

University of Alabama at Birmingham Cancer Center
Verified postcode
Birmingham, United States
Veterans Administration Medical Center - Birmingham
Verified postcode
Birmingham, United States
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
Cancer Center at Saint Joseph's
Verified postcode
Phoenix, United States
Banner University Medical Center - Tucson
Verified postcode
Tucson, United States
University of Arizona Cancer Center-North Campus
Verified postcode
Tucson, United States
Kaiser Permanente-Anaheim
Verified postcode
Anaheim, United States
Sutter Auburn Faith Hospital
Verified postcode
Auburn, United States
AIS Cancer Center at San Joaquin Community Hospital
Verified postcode
Bakersfield, United States
Kaiser Permanente-Baldwin Park
Verified postcode
Baldwin Park, United States
Kaiser Permanente-Bellflower
Verified postcode
Bellflower, United States
Alta Bates Summit Medical Center-Herrick Campus
Verified postcode
Berkeley, United States

Common questions

What is nivolumab and how does it work?

Nivolumab is an immunotherapy drug. It helps your body's own immune system find and fight cancer cells more effectively.

What does 'localized kidney cancer' mean?

It means the cancer is currently found only in your kidney or very close by, and has not visibly spread to other distant parts of your body.

Will I definitely get the new drug if I join the study?

No, you'll be randomly assigned to either receive the new drug along with surgery, or surgery alone followed by standard care. It's like flipping a coin.

How long will I be involved in the study?

If you receive nivolumab, treatment usually lasts about a year. You'll then be followed up for several more years to monitor your health and recovery.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting your standard medical care.