PDR 001 in Acute myeloid Leukaemia or high risk MDS

• Research type

  Research Study

• Full title

  A phase 1b multi arm open label study of PDR001 and /or MGB453 in combination with decitabine in patients with acute myeloid leukaemia or high risk myelodysplastic syndrome

• IRAS ID

  224410

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2016-005060-33

• Duration of Study in the UK

  1 years, 10 months, 25 days

• Research summary

  Research Summary

  This is a phase 1b, multi-arm, open-label study in adult patients with relapsed or refractory acute myeloid leukaemia ( AML) or previously untreated AML who are not candidates for standard induction therapy, or high risk MDS.
  The purpose of this study is to estimate the maximum tolerated dose (MTD) and/or
  identify a recommended dose (RD) of PDR001 and/or MBG453 administered in combination with decitabine.
  The study is comprised of three combination arms.
  1. Evaluation of a fixed dose of the standard of care agent decitabine in combination with fixed dose PDR001(Arm 1)
  2. Evaluation of a fixed dose of the standard of care agent decitabine in combination with escalating dose MBG453 (Arm 2)
  3. Evaluation of a fixed dose of the standard of care agent decitabine in combination with fixed dose PDR001 and escalating dose MBG453 (Arm 3)
  combination with decitabine in this patient population.

  Summary of Results
  The English lay summary is available to PIs to share with patients and posted in the public domain on Novartis public website https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novctrd.com%2F&data=05%7C02%7CWales.REC1%40wales.nhs.uk%7C0abbcf5c41aa4cf6cefc08dd0d5d3ba4%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638681416276066695%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=JMQbJwDgd1X4Wvw%2BMIVSKrIVacGlOgT7nouGF0X0RTQ%3D&reserved=0

  Available at: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.novctrd.com%252Fctrdweb%252Fpatientsummary%252Fpatientsummaries%253FpatientSummaryId%253D2288%2FNBTI%2FAZm5AQ%2FAQ%2F9b8e5993-5b1c-482b-9ee5-f37aed3f780c%2F2%2Fk66cyW250Y&data=05%7C02%7CWales.REC1%40wales.nhs.uk%7C0abbcf5c41aa4cf6cefc08dd0d5d3ba4%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638681416276084495%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=xNppW07mNtxqoiRc2Zb30b6Ya7YyPLW3kvzEvz4r2eg%3D&reserved=0

• REC name

  Wales REC 1

• REC reference

  17/WA/0135

• Date of REC Opinion

  9 May 2017

• REC opinion

  Further Information Favourable Opinion