Phase 3 trial of etoposide/platinum with or without pembrolizumab

• Research type

  Research Study

• Full title

  A Phase III Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK 3475/SCH900475) in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects with Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)

• IRAS ID

  222471

• Contact name

  Riyaz Shah

• Contact email

  riyaz.shah@nhs.net

• Sponsor organisation

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

• Eudract number

  2016-004309-15

• Duration of Study in the UK

  4 years, 4 months, 15 days

• Research summary

  Summary of Research
  Small cell lung cancer (SCLC) is an aggressive neuroendocrine cancer, with high growth rate and early development of widespread metastases. It accounts for 14% of all lung cancers and approximately 275,000 patients worldwide are diagnosed annually.
  Although SCLC is sensitive to chemotherapy and radiation, normally it reappears quickly after primary treatment, with only 6% of patients surviving 5 years from diagnosis. Treatment of SCLC is notable for the lack of major developments. Nearly 4 decades after the introduction of an etoposide/platinum doublet chemotherapy, therapeutic options have remained nearly unchanged, with little improvement in survival rates. Therefore, an unmet need remains after treatment with currently therapies and clinical trials are an option for research of further treatment.
  Programmed cell death 1 (PD1) is a receptor protein present on the surface of immune cells (T-cells), which fight cancer. When immune cells encounter cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) proteins on the surface of cancer cells. Interaction between these ligands and the receptors prevents the immune cells from attacking the cancer cells. The study drug pembrolizumab has been designed to block PD1/PDL1 interaction to increase the immune attack on cancer cells.
  This is a Phase III, placebo-controlled trial of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum) (EP) in participants with extensive stage SCLC who have not previously received systemic therapy for this malignancy. The trial will study safety, tolerability and efficacy of pembrolizumab in combination with SOC chemotherapy by evaluating if pembrolizumab and EP increase primary and secondary objectives compared with placebo and EP.
  Approximately, 430 male/female participants (≥18yrs) will be enrolled and the trial will last approximately 4.5 years.
  The study is funded by Merck Sharp & Dohme Limited and will take place at 5 study centres in the UK.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfZLMhYNSL6uAQ3D-2BHysQkrDfLhLttCSlqwZU8YfhnEKSEZiVXzmxxNRk52NU-2Fwzhml0CvaLhfwGrmTx2pHuf3xIn4UAT2rYzpYDwU2NHzCr9g-3D-3DJx5a_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJUGIU6QsL8C-2FQhCavSrPzFtQ7-2F1D6kDRuD2DTc8S6FV3Lh1nNZy2vVKiUKqPQQivh-2B-2FMtHoEnJxswo68CGvxJydjeymdI-2FKR0wz7tgM0AKR6-2FRTMKDJBxLt5KrisiYvAAckGiXeOasEFV20KgDFPfzcmqqsbfuvY-2BbCfhgQYB3jw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C5fdd91289a33467a824208db196c59ce%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638131725398049449%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=gqghGPvLsgFVOGq35%2FGO4WzQ5VpVhJ2WJtL1NhI4NCI%3D&reserved=0

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  17/LO/0441

• Date of REC Opinion

  28 Apr 2017

• REC opinion

  Further Information Favourable Opinion