MK-3475 versus SOC in 1L Subjects with PD-L1 Strong Metastatic NSCLC

• Research type

  Research Study

• Full title

  A Randomized Open-Label Phase III Trial of MK-3475 versus Platinum based Chemotherapy in 1L Subjects with PD-L1 Strong Metastatic Non-Small Cell Lung Cancer

• IRAS ID

  152364

• Contact name

  Christian Hermann Heinrich Ottensmeier

• Contact email

  C.H.Ottensmeier@soton.ac.uk

• Sponsor organisation

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

• Eudract number

  2014-000323-25

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Summary of Research
  The drug being tested in this study is a PD1 inhibitor called MK-3475. PD1 is present on the surface of cells of the immune system which fight cancer but when they encounter cancer cells PD1 becomes activated by PDL1 on the surface of the cancer cells. This has the effect of making the immune cells die or become exhausted thus stopping them from attacking the cancer. Blocking PD1 activity increases the immune attack on cancers. PD1 inhibitors have already achieved impressive results in lung cancer and this study will look at how active MK-3475 is in lung cancer.
  The purpose of this study is to see how effective is MK-3475 in comparison to the current standard of care when given to Non-Small Cell Lung Cancer (NSCLC) patients and to obtain further insights into the activity of MK-3475 in treating tumours.
  Lung cancer remains a huge problem in the UK and a massive area of unmet therapeutic need. It is the second most common cancer with 41,428 new cases in 2009 but is the most common cause of cancer death. In 2010, there were 34,859 deaths from lung cancer in the UK. Thus, the search for new treatments is crucial and arming the immune system is one intriguing new approach.
  Patients with NSCLC which express high PDL1 (>50%) on the surface of the cancer cells will be eligible.
  Patients enrolled in the MK-3475 arm, will receive study drug as an intravenous infusion, every 3 weeks for 30 min.
  Patients enrolled in the standard of care arm will receive treatment accoding to Hospital policy.
  Patients will be monitored regularly for safety and clinical and/or radiographic evidence of disease progression according to usual standards practice.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2FzlLN2Jg004DuEIv9Y3aHeZHefSaP-2F6BTWiOEUk1AqMappwqd2QA7dyoMMWeuhnOKiIOylecVaazFtPRx2-2B9bXFg-3D-3DIXcc_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK95MsQqz-2BWtlyPXUOzwQCyi-2FtD-2B1JFrHHhmo6hrMrX0YWP-2FyHWvmMArhupq7TL7YoP7GgP-2BeBvshVFrrD6BmXsUKCranmfBGaa3oxAVzHOOmxmAJ5MMSgS8FMvq6hoZvcbYIS-2BpVRQfA7x0k-2BCVr1NmjcoQXXlNBrUhb55OlHXsA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ce67e640aef8a486bca0e08da605950ce%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637928233985395795%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=CZew%2FOk3iHOYZPB7uD%2F7%2BnDgBc63IOs8XmEuDKkDEok%3D&reserved=0

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  14/LO/0818

• Date of REC Opinion

  25 Jun 2014

• REC opinion

  Further Information Favourable Opinion