Pembrolizumab (MK-3475) vs Paclitaxel in 2L Subjects with Advanced Gastric Adenocarcinoma

• Research type

  Research Study

• Full title

  A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel in Subjects with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma who Progressed after First-Line Therapy with Platinum and Fluoropyrimidine

• IRAS ID

  174771

• Contact name

  Ildiko Csiki

• Contact email

  ildiko.csiki@merck.com

• Sponsor organisation

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

• Eudract number

  2014-005241-45

• Clinicaltrials.gov Identifier

  061, Keynote

• Duration of Study in the UK

  3 years, 0 months, 4 days

• Research summary

  Summary of Research
  This is a Phase III, open-label trial of pembrolizumab (MK-3475) versus paclitaxel in subjects with advanced gastric or gastroesophageal junction adenocarcinoma who have progressed after First-Line Therapy with Platinum and Fluoropyrimidine.

  The drug being tested in this study (pembrolizumab) is a PD1 inhibitor. PD1 is present on the surface of immune cells which fight cancer. When immune cells encounter cancer cells, PD1 becomes activated by PD-L1 and PD-L2 which are present 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. The study drug pembrolizumab (MK-3475) has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.

  This study will recruit approximately 720 men and women worldwide, who are at least 18 years old. These subjects will be randomized in a 1:1 ratio to one of two treatment groups. One treatment group will receive pembrolizumab (MK-3475) via infusion on Day 1 of every 3 week cycle. The other treatment group will receive paclitaxel via infusion on Days 1, 8 and 15 of each 4 week cycle.

  The purpose of the study is to test the safety, tolerability and anti-tumour activity of pembrolizumab (MK-3475) versus paclitaxel. 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.

  Prior to enrolment, subjects will be required to provide a tumour tissue sample, which will be evaluated to identify a cancer biological marker called PD-L1 (PD-L1 expression status). Initially recruitment in the study will commence without regard for PD-L1 expression status.

  The study will take place in UK Hospital sites and approximately 26 patients will be recruited in the UK. The study is funded by Merck Sharp & Dohme Limited.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2FzQ2L6kXkCqeGlApr0ouX2zvgpzCS3JfOabnmW12jxEidUyI37ADrVvcVt8ztWtaEMMZ3zgw4v7i0h7eVmcVfN7w-3D-3DRqL7_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YI9NNya-2F6cRRLkmGHbHRhnbuis8SBPrl2Ntubv62Hqb8NqAiJy3du6vWOm-2FJ8c-2BuV2bJ-2BzgaLAjfo-2FIawG9HGpQ1-2BejnMSdeZGO1OKihifSm-2F9zzYo5rLVkS63LYlPbxfkvUNjg31qsfwOSFI4yCWOzYiPcFsNM6zowAfarp7COSQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca5945f6c43de4726b3f008da8f2fec93%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637979733246666296%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=3uvpe8FwWP1l%2FF%2BcpQ5maZon4Um1alfDYNlGLRqMKTI%3D&reserved=0

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  15/NW/0382

• Date of REC Opinion

  23 Jun 2015

• REC opinion

  Further Information Favourable Opinion