CA209-743: Phase III unresectable Pleural Mesothelioma

• Research type

  Research Study

• Full title

  A Phase III, Randomized, Open Label Trial of Nivolumab in combination with Ipilimumab versus Pemetrexed with Cisplatin or Carboplatin as First Line Therapy in unresectable Pleural Mesothelioma

• IRAS ID

  218645

• Contact name

  Dean Fennell

• Contact email

  df132@le.ac.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2016-001859-43

• Duration of Study in the UK

  4 years, 6 months, 25 days

• Research summary

  Research Summary: The PD-1 inhibitor nivolumab (Opdivo) is approved in the EU for the treatment of patients with advanced melanoma, locally advanced or metastatic non-small cell lung cancer (NSCLC), and advanced renal cell carcinoma (RCC). It is also in development for a range of other cancers. The combination of nivolumab and ipilimumab has also been approved for the treatment of previously untreated metastatic melanoma.

  Patients with malignant pleural mesothelioma (MPM) that cannot be treated with surgery (unresectable) have a poor prognosis and experience limited survival benefit with standard platinum based chemotherapy. Results from early trials has shown activity of PD-1 inhibitors in MPM that has come back after initial treatment with chemotherapy that warrants further study. Nivolumab in combination with ipilimumab is being tested in this study to determine whether it can improve outcomes in patients with unresectable MPM undergoing treatment for the first time.
  Following a screening period, suitable patients will be randomly (by chance) selected to 1 of 2 treatment arms. Patients will receive either:

  Arm A: nivolumab administered through a drip (IV) over 30 minutes at 3 mg/kg every 2 weeks combined with ipilimumab administered IV over 30 minutes at 1mg/kg every 6weeks until progression, unacceptable toxicity, or other reasons specified in the protocol. Or;
  Arm B: pemetrexed plus cisplatin or carboplatin chemotherapy administered on day 1 of every 21 day cycle for up to a maximum of 6 cycles. Chemotherapy treatment will continue until the cancer progresses, unacceptable side effects or completion of 6 cycles, whichever comes first.
  The study will close to new patients after approximately 600 patients have been randomised. Approximately 36 of these patients will be from the UK.
  Patients will undergo the following tests and procedures during the study: tumour tissue biopsy (possible), CT scans, physical exams, heart tracing, blood pressure/heart rate checks, and blood sampling for routine safety testing and study specific testing.

  Patients will be treated by trained oncology teams in NHS hospitals.
  The study is sponsored by Bristol-Myers Squibb.

  Summary of Results:
  https://clinicaltrials.gov/study/NCT02899299?term=%20NCT02899299&rank=1&tab=results

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  17/SC/0016

• Date of REC Opinion

  13 Mar 2017

• REC opinion

  Further Information Favourable Opinion