Phase II Study of Pembrolizumab in Advanced Recurrent Ovarian Cancer

• Research type

  Research Study

• Full title

  A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects with Advanced Recurrent Ovarian Cancer

• IRAS ID

  196825

• Contact name

  Jonathan Ledermann

• Contact email

  j.ledermann@uclh.nhs.uk

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2015-003338-29

• Duration of Study in the UK

  3 years, 11 months, 28 days

• Research summary

  Research Summary
  This is a Phase II study of pembrolizumab in patients with advanced recurrent ovarian cancer (ROC). Ovarian cancer is the cancer of the ovaries and is the fifth leading cause of death among women in the UK. Despite receiving diagnosis with primary treatment, recurrence of ovarian cancer is common and is not curable and therefore is an area of highly unmet clinical need.
  The drug being tested in this study is pembrolizumab, a Programmed cell death protein 1 (PD-1) inhibitor. PD-1 is a protein that plays a key role in controlling T cell activity of the immune system. Binding of PD-1 to it’s ligands, Programmed Death Ligand 1 (PD-L1) or Programmed Death Ligand 2 (PD-L2), reduces T cell function thereby leading to survival of cancer cells. Pembrolizumab works directly by blocking the interaction between PD-1 and PD-L1 enhancing the functional activity of immune response on cancer cells.
  This open-label study will recruit approximately 325 patients of at least 18 years of age with advanced ROC. Patients will be divided in two different groups: Group A which will enrol patients with ROC who have received 0-2 prior lines for treating ROC and with a treatment free interval of 3-12 months and Group B which will enrol patients with ROC who have received 3-5 prior lines for treating ROC with treatment free interval ≥3 months. In both groups, patients will be treated with 200 mg pembrolizumab every 3 weeks.
  Patients may receive treatment for up to 24 months and they will be monitored regularly for safety and clinical and/or radiographic evidence of disease progression.
  The overall aim for this study is to evaluate the effectiveness of pembrolizumab in treating ovarian cancer.
  The study will take place at 5 centres in the UK and is funded by Merck Sharp & Dohme Limited.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2FzXFbuALQnGcmfrax6xRFkFMvj-2B4uYgshcS2XnD7SJ7OBtJ2YAVsOUHvxIDwcT7THxZ41xU83JmzBC6ijwkxUXvg-3D-3DlACr_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIK-2Fc5jLhfrxlDer9mSDmPiMcmNtDoaEkA9nIigY4wn0NyIEaaC6AwJbpS1LFksP43lVZGqc14H6aqgaKDyNRJxdUor2KqsLIPGwCy8Se93DhVUG94fidX1-2FDPX0-2Fd-2Bm1q-2Fp447iuSHszY49UiRrSf2qF-2BZYzcaxEA6nLqWJZbVdg-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7Ce8525cc9fd684e5abbb108da10cfb219%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637840781470238896%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=PS7hAcAAjvxr4GmsqbDudFC05IvfKxdQsVxDfc9emkk%3D&reserved=0

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  16/LO/0333

• Date of REC Opinion

  18 Apr 2016

• REC opinion

  Further Information Favourable Opinion