CONFIRM

 mesothelioma / Posted 1 year ago

ORPHA:168811 Malignant peritoneal mesothelioma ORPHA:168816 Peritoneal cystic mesothelioma ORPHA:50251 Pleural mesothelioma

CheckpOiNt blockade For Inhibition of Relapsed Mesothelioma (CONFIRM): A Phase III Trial to Evaluate the Efficacy of Nivolumab in Relapsed Mesothelioma

Doctors treat mesothelioma with chemotherapy. After chemotherapy if the mesothelioma comes back the aim is to control symptoms. This is called active symptom control.

Researchers want to find out if nivolumab can help these people.

Nivolumab is a type of immunotherapy drug called a monoclonal antibody. It works by stimulating the body’s immune system to recognise and kill cancer cells.

We know from research that nivolumab could help people whose mesothelioma has come back after chemotherapy. But it isn’t known if it as good as active symptom control.

In this trial most people will have nivolumab and some will have a dummy drug (placebo).

The main aims of the trial are to find:

  • how well nivolumab works for people whose mesothelioma has come back after chemotherapy
  • how safe it is
  • how it affects quality of life
  • Inclusion Criteria :
    • You have mesothelioma that has come back after chemotherapy treatment
    • You have had at least 1 course of treatment
    • You have had a CT scan Open a glossary item that shows your mesothelioma is getting worse
    • Your mesothelioma can be measured on a scan
    • You are willing to provide a sample of tissue and blood for the trial
    • You have satisfactory blood test results
    • You are able to take care of yourself (performance status 0 or 1
    • You are willing to use 2 forms of reliable contraception during treatment and for 7 months afterwards if there is any chance
    • you or your partner could become pregnant
    • You are at least 18 years old
  • Exclusion Criteria :
    • You are allergic to nivolumab or similar drugs (monoclonal antibodies)
    • You have a problem with alcohol or drugs
    • You are pregnant or breastfeeding
  • Study start date : 28/03/2017
  • Study end date : 14/02/2021
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Jason Lester

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