A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients With Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Study on Nephrectomy with or without Investigational Medication for Localized Kidney Cancer

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized).

Detailed description of study

The purpose of this study is to compare recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: renal cancer,Renal Cell Carcinoma,kidney cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • 18 years or older
  • Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1803706029 (EA8143)

This study investigates the effectiveness of nephrectomy, a surgery to remove a kidney or part of it, with or without an investigational medication in patients with localized kidney cancer. The purpose is to compare how long patients remain free of cancer recurrence after treatment. Localized kidney cancer means the cancer is limited to a specific area and has not spread to other parts of the body.

Participants in this study will undergo either surgery alone or surgery combined with the investigational medication. The investigational medication is used to see if it can improve outcomes when given around the time of surgery. Nephrectomy can be either radical, removing the entire kidney, or partial, removing only the affected part.

  • Who can participate: Adults aged 18 years or older with newly diagnosed, higher risk renal cell carcinoma (RCC) of any histology, including sarcomatoid, are eligible to participate.
  • Study details: Participants will either have surgery alone or surgery with an investigational medication. The investigational medication is given around the time of surgery to evaluate if it improves outcomes.

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Default Content Message Here