MS201943-0029-Avelumab+M6620+Carboplatin in PARPi-resistant Ov Cancer

• Research type

  Research Study

• Full title

  A Phase II, Randomized, Open-label Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of M6620 in Combination with Avelumab and Carboplatin in Comparison to Standard of Care Therapy in Participants with PARPi-resistant Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

• IRAS ID

  251643

• Contact name

  Susana Banerjee

• Contact email

  susana.banerjee@rmh.nhs.uk

• Sponsor organisation

  Merck KGaA

• Eudract number

  2018-001534-17

• Duration of Study in the UK

  2 years, 7 months, 8 days

• Research summary

  In recent years, drugs called PARP inhibitors such as olaparb and nirapaib have become available for women with recurrent ovarian cancer. These new treatments have improved outcomes for patients but for the majority of women, at some point, the cancer worsens and becomes ‘resistant’ to PARP inhibitors. It is not known how best to treat patients with recurrent/worsening ovarian cancer who have been treated with PARP inhibitors. This Phase 2, randomised, open-label trial is testing a new combination of drugs (M6620 + carboplatin + avelumab) and comparing this to standard chemotherapy.

  This combination treatment will be tested in participants that have been diagnosed with ovarian, primary peritoneal, or fallopian tube cancer that has recurred after an initial drug treatment with poly (ADP ribose) polymerase inhibitor (PARPi).

  The study is divided into two parts, Part A and Part B:
  • In Part A, the purpose is to evaluate the safest dose of M6620 when the study medication is used together (triplet combination).
  • In Part B, the purpose is to see how well the study medication works when used together and how safe it is compared with standard-of-care treatment. The dose of M6620 used will be based on the results from Part A.
  Participants will only participate in Part A or Part B depending on when they join the study.

  In Part A, between 3 and 18 participants will participate.
  In Part B, approximately 72 participants will participate.

  Both Part A and Part B of the study will have 3 main periods:
  • Screening period (4 weeks)
  • Treatment period (up to 18 weeks) and maintenance treatment period
  • Follow-up period (3 months up to 1 year).

  In addition to the UK, the study will be conducted in about 35 medical centres in the European Union (Italy & Belgium) and the United States. The study is anticipated to last until November 2022.

  Enrolment timelines;
  Planned start date UK: 15 December 2018
  Last Patient In UK: July 2021
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  18/LO/1680

• Date of REC Opinion

  8 Nov 2018

• REC opinion

  Further Information Favourable Opinion