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    A Clinical Trial of Atezolizumab in Patients with Renal Cell Carcinoma that is at High Risk of Coming Back After Surgery (IMmotion010)

    A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy (IMmotion010)

    • Cancer
    • Renal Cell Cancer (RCC)
    • Renal Cell Carcinoma

    Basic Details

    Gender
    All
    Age
    ≥ 18 Years
    Healthy Volunteers
    No
    Sponsor Hoffmann-La Roche
    Phase Phase 3
    Study Identifier NCT03024996, WO39210, 2016-001881-27

    How does the IMmotion010 clinical trial work?

    This clinical trial is recruiting people who have had a type of kidney cancer called ‘renal cell carcinoma’ or RCC, which has been removed with surgery. The aim of the clinical trial is to stop or delay your RCC from coming back.

    This clinical trial is for people who have not been given any treatment known as ‘immunotherapy’ (treatment that helps your own immune system to kill cancer) for their cancer and have had surgery to remove some or all of the kidney (known as a partial or full ‘nephrectomy’).

    How do I take part in this clinical trial?
    If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor.

    If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor who will give you all the information you need to make your decision about taking part in the clinical trial. You will also find the clinical trial locations at the top of this page.

    You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests and procedures may be part of your regular medical care and may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

    Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial and what other treatments are available so that you may decide if you still want to take part.  

    What treatment will I be given if I join this clinical trial?
    If you agree to take part in this clinical trial, and your doctor confirms that you are at high risk of your cancer coming back around your kidney or other parts of your body, then you may be able to be given treatment for your specific type of cancer.

    Everyone who joins the clinical trial will be split into two groups randomly (like flipping a coin) and given one of two different treatments. You will either be given the new medicine atezolizumab or you will be given an alternative with no active drug (called a ‘placebo’). Some people will be given a placebo to help the doctors see whether any effects seen with the test medicine, atezolizumab, are real or not. You will be given the treatment into your vein (this is called an ‘intravenous infusion’) once every 3 weeks for a maximum of 16 cycles (each cycle is 21 days) or 1 year (whichever occurs first).

    How often will I be seen in follow-up appointments, and for how long?
    Before you are given each treatment, at the beginning of each treatment cycle, you will need to have blood tests. You will also meet your doctor several times a year until the end of the clinical trial to talk about how you are responding to the treatment (if your cancer has not come back) and any side effects that you may be having.

    What happens if I’m unable to take part in this clinical trial?

    If your specific cancer type does not match what this clinical trial is looking at and/or the results of your blood tests are not in the range needed for the trial, you will not be able to take part in this clinical trial. Your doctor will suggest other treatments for your cancer that you can be given or other clinical trials that you may be able to take part in. You will not lose access to any of your regular care.

    For more information about this clinical trial see the For Expert tab on this page or follow this link to ClinicalTrials.gov

    Trial-identifier: NCT03024996

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    What you can do next

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    Together, you can look at the For Medical Professional tab and look into your medical history.

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      What is Clinical Research?

      In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.