D910FC00001 Long Term safety of Durvalumab (WAVE)

• Research type

  Research Study

• Full title

  An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

• IRAS ID

  270522

• Contact name

  Anne Armstrong

• Contact email

  anne.armstrong@christie.nhs.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2019-001402-20

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 8 months, 1 days

• Research summary

  Summary of Research

  This is a multicentre, open-label study that will enrol participants who are currently receiving the study drug, durvalumab or have previously received durvalumab as on its own or in combination with other drugs in an eligible clinical study (the parent study). The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible participants, and to collect overall survival information.

  Participants in this study will be enrolled into one of 3 Cohorts:
  • Group 1 – includes participants who have received durvalumab either alone or in combination with another anticancer drug in the parent study, and who will continue to receive only durvalumab after completing dosing of all other anticancer agents in the parent study.
  • Group 2 – includes participants who have received durvalumab either alone or in combination with another anticancer drug in the past and may or may not receive durvalumab again.
  • Group 3 – includes participants who have received durvalumab either alone or in combination with another anticancer drug in the past but are no longer eligible to receive durvalumab.

  Participants in Cohort 1 and those going onto durvalumab retreatment in Cohort 2 will receive durvalumab monotherapy. Participants in Cohort 3 will not receive any study drug.

  Continuation with durvalumab monotherapy (Cohort 1) and retreatment with durvalumab monotherapy (Cohort 2) will continue until confirmed progressive disease.

  The study will not close if any participant is still receiving durvalumab treatment. The survival follow-up period will end no earlier than after the last participant receives their last dose of durvalumab.

  This study will initially enrol approximately 600 participants.
  The number of participants is subject to change as new parent studies are included into this long-term safety and efficacy study.

  Summary of Results
  Lay summary of study results was not written for the study please refer to abbreviated CSR
  

• REC name

  West of Scotland REC 1

• REC reference

  19/WS/0144

• Date of REC Opinion

  12 Nov 2019

• REC opinion

  Further Information Favourable Opinion