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    A clinical trial to look at how well atezolizumab works when taken with other drugs, compared to atezolizumab alone, in people with bladder cancer

    Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

    • Cancer
    • Bladder Cancer
    • Urothelial Carcinoma

    Basic Details

    Gender
    All
    Age
    ≥18 Years
    Healthy Volunteers
    No
    Sponsor Hoffmann-La Roche
    Phase Phase 1/Phase 2
    Study Identifier NCT03869190, WO39613

    How does the WO39613 clinical trial work?

    This clinical trial is recruiting people who have bladder cancer that has spread to the muscle layer of the bladder (muscle invasive bladder cancer or MIBC).

    The purpose of this clinical trial is to compare the effects, good or bad, of atezolizumab when taken with other drugs, compared to atezolizumab alone, in participants with MIBC. Patients will also have surgery during the study to remove the bladder, which is a standard treatment for MIBC.

    Atezolizumab is an antibody that may help your immune system stop or reverse the growth of tumours. Atezolizumab is approved in some countries for the treatment of bladder cancer, lung cancer, breast cancer, liver cancer, and skin cancer. Participants who join this clinical trial will be given either atezolizumab alone or atezolizumab with another drug called tiragolumab. Tiragolumab is also an antibody that may help your immune system stop or reverse the growth of tumours. Patients who are healthy enough to receive chemotherapy (a standard treatment for MIBC) will receive cisplatin and gemcitabine in addition to atezolizumab/tiragolumab. 

     

    How do I take part in this clinical trial?

    To be able to take part in this clinical trial, you must have been diagnosed with MIBC and be at least 18 years old. You must not have previously been given any of the medicines being tested in this clinical trial and you cannot join the trial if you are pregnant or breastfeeding.

    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. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on 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 or procedures may be part of your regular medical care. They 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. You will also be told what other treatments are available so that you may decide if you still want to take part.

    While taking part in the clinical trial, women who can become pregnant will need to either avoid heterosexual intercourse or use contraception for safety reasons. Men that have a female partner who can become pregnant may need to follow the same restrictions.

     

    What treatment will I be given if I join this clinical trial?

    Participants will receive treatment based on their ability to receive cisplatin-containing chemotherapy. Participants will then be split randomly to receive atezolizumab or atezolizumab plus at least one other drug:

    For participants who cannot be given cisplatin:

    • Atezolizumab alone, given as an infusion into your vein on the first day of each treatment cycle, which lasts for 21 days, for 3 cycles before surgery and 14 cycles after
    • OR atezolizumab and tiragolumab, both given as an infusion into your vein on the first day of each treatment cycle, for 3 cycles before surgery and 14 cycles after

     

    For participants who can be given cisplatin:

    • Atezolizumab given as an infusion into your vein every 3 weeks for 3 treatment cycles before surgery and 14 cycles after, plus
    • Cisplatin given as an infusion into your vein every 3 weeks for 3 cycles before surgery, and
    • Gemcitabine given as an infusion into your vein on the first and eighth day of each treatment cycle (lasting 21 days), for 3 cycles before surgery

    OR

    • Atezolizumab and tiragolumab, both given as an infusion into your vein every 3 weeks for 3 treatment cycles before surgery and 14 cycles after, plus
    • Cisplatin given as an infusion into your vein every 3 weeks for 3 cycles before surgery, and
    • Gemcitabine, given as an infusion into your vein on the first and eighth day of each treatment cycle (lasting 21 days), for 3 cycles before surgery

     

    How often will I be seen in follow-up appointments and for how long?

    You will be given the clinical trial treatment (atezolizumab alone or with another drug/drugs) every 3 weeks for approximately 1 year. You are free to stop this treatment at any time. After being given your final treatment, you will still be seen by the clinical trial doctor within 1 month and then every 3 months after that. These visits will include checks to see how you are responding to the treatment and any side effects that you may be having. In some cases, these visits may take place over the phone.

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

    If this clinical trial is not suitable for you, you will not be able to take part. Your doctor may suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

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

    Trial-identifier: NCT03869190

    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

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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.