B9991009 Phase 3, avelumab for Platinum-Resistant Ovarian Cancer

• Research type

  Research Study

• Full title

  A phase 3, multicenter, randomized, open-label study of avelumab (MSB0010718C) alone or in combination with Pegylated Liposomal Doxorubicin versus Pegylated Liposomal Doxorubicin alone in patients with platinum resistant/refractory ovarian cancer

• IRAS ID

  187317

• Contact name

  Jonathan Ledermann

• Contact email

  j.ledermann@ucl.ac.uk

• Sponsor organisation

  Pfizer Ltd.

• Eudract number

  2015-003091-77

• Clinicaltrials.gov Identifier

  NCT02580058

• Duration of Study in the UK

  2 years, 1 months, 0 days

• Research summary

  Research Summary:

  Ovarian cancer is the leading cause of death from gynecologic cancer and fifth most common cause of cancer mortality in women.

  Patients are considered having platinum-sensitive disease if they respond to first line platinum therapy and experience a relapse free period of greater than 6 months following the last dose of platinum therapy. Platinum-resistant disease is defined by relapse between 0 to 6 months after the last platinum dose.

  Avelumab is a new investigational drug. Avelumab is thought to work by helping the immune system fight cancer cells. It is currently under investigation, whether using avelumab alone or in combination with Pegylated Liposomal Doxorubicin (PLD), could be used to treat ovarian cancer. PLD is a drug that is already approved by the health authorities in the UK for the treatment of ovarian cancer.

  The main purpose of this study is to compare the effects of the study drug, avelumab (MSB0010718C), when given alone or in combination with pegylated liposomal doxorubicin (PLD, also called Caelyx), to PLD given alone to find out which is better for treating ovarian cancer.

  Participants in the study, can not choose a group, but will be assigned by chance (like the flip of a coin) to receive either avelumab alone (Group A), avelumab in combination with PLD (Group B), or PLD alone (Group C). There is a 33% (1 in 3) chance of being in group A, B or C.

  It is an open-label study which means participants and study doctor will know which of these study drug groups have been assigned to the participant.

  Summary of Research:
  https://clinicaltrials.gov/study/NCT02580058?tab=results

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  16/NE/0027

• Date of REC Opinion

  11 Mar 2016

• REC opinion

  Further Information Favourable Opinion