Pembrolizumab+FP/XP vs. Placebo+FP/XP in Biomarker Select, Advanced Gastric or GEJ Adenocarcinoma

• Research type

  Research Study

• Full title

  A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

• IRAS ID

  182797

• Contact name

  Janet Graham

• Contact email

  Janet.Graham@ggc.scot.nhs.uk

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Eudract number

  2015-000972-88

• Clinicaltrials.gov Identifier

  NCT02494583

• Duration of Study in the UK

  3 years, 8 months, 14 days

• Research summary

  Research Summary

  Programmed cell death 1 (P01) is a protein present on the surface of immune cells which fight cancer. When immune cells encounter cancer cells, P01 becomes activated by programmed cell death ligand 1 (POL1) and POL2 which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. The study drug Pembrolizumab has been developed to block P01/POL1 interaction, thereby increasing the immune attack on cancers. Pembrolizumab has shown promising results in clinical trials on subjects with gastric cancer where it has generally been well tolerated.

  The purpose of this study is to compare the effectiveness and safety of Pembrolizumab on its own, as well as in combination with chemotherapy, versus just chemotherapy as first line therapy in subjects with gastric cancer. The chemotherapy used will be cisplatin with either 5-Fiurouracil (5FU) or capecitabine. This study will recruit men and women who are at least 18 years of age and have locally advanced gastric or metastatic gastric or Gastro­ oesophageal Junction (GEJ) adenocarcinoma.
  The main study treatment will last up to 2 years. Patients will be divided in three treatment groups in a 1:1:1 ratio in this partially blinded study. One group will receive pembrolizumab every 3 weeks, one group will receive pembrolizumab & cisplatin with either 5FU or capecitabine every 3 weeks, and one group will receive placebo and cisplatin with either 5FU or capecitabine every 3 weeks. Subjects will be monitored regularly for safety and clinical and/or radiographic evidence of disease progression. Subjects must have provided tumour tissue sample deemed adequate for POL1 biomarker analysis and be POL1 positive in order to participate in the study.

  Approximately 750 subjects will be enrolled in the study globally, there will be about 12 subjects in 4 sites 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-2Fi4xyo44sEgJVCl5BcbW9wgc64X2JjNxW-2BqMpAMBC-2FPhnMmxkDpHlvpJAEZQc38rRontkmZ49aPWAkXusKKbweftLeRBXObDC1o3KacJh-b_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKk6MKx5Wjw8eS6qK0tfuacZowP-2FGH7CR1wuF-2FZGSKaqpWJAF3aKKcXYjGG1tfKw-2BOCqAVXbxNKdvAhdXUveobkZJ4X4Jmun35CCQi-2BAUj0FfThLe6wDQWHBjM6fR4Lsl74Ur580f53agMBJRksL-2FVgfhWVRwAaCeFvKv77wrLBozDzrfREbMEX2b2Xv60uc2w-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C75b1c5e724f742743d5508db3a9f37bb%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638168227727492480%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=sna7ZRtmKmalwCryUOal3HSvDmbsdQqJiJJaT%2BM2hxo%3D&reserved=0

• REC name

  West of Scotland REC 1

• REC reference

  15/WS/0174

• Date of REC Opinion

  5 Nov 2015

• REC opinion

  Further Information Favourable Opinion