MK3475 vs standard treatment in subjects with head and neck cancer

• Research type

  Research Study

• Full title

  A Phase III Randomized Trial of MK-3475 (Pembrolizumab) versus Standard Treatment in Subjects with Recurrent or Metastatic Head and Neck Cancer

• IRAS ID

  162637

• Contact name

  Martin Forster

• Contact email

  martin.forster@uclh.nhs.uk

• Sponsor organisation

  Merck Sharp & Dohme LLC.

• Eudract number

  2014-001749-26

• Duration of Study in the UK

  2 years, 3 months, 9 days

• Research summary

  Summary of Research
  Head and Neck cancer describes a range of tumours that arise in the head and neck region, which includes the oral cavity, pharynx, larynx, nasal cavity, paranasal sinuses, thyroid, and salivary glands. Head and Neck cancer is the fifth most common cancer worldwide.

  Patients with Metastatic Head and Neck Cancer (cancer which has spread to other parts of the body) which has returned or progressed after chemotherapy generally have a poor prognosis. Most patients have an average life span of 7 to 9 months with limited treatment options. Therefore new treatment options are crucial.
  Programmed cell death 1 (PD1) is a protein present on the surface of immune cells which fight cancer, but when they encounter cancer cells PD1 becomes activated by programmed cell death ligand 1 (PDL1) and PDL2 which are proteins on the surface of cancer cells. Resulting in the immune cells dying or becoming exhausted thus stopping them from attacking the cancer. MK-3475 prevents the PD1 on the immune cells from reacting with the PDL1 on the cancer cells. Blocking PD1 activity increases the immune attack on cancers.

  This study aims to evaluate the overall survival and progression free survival in patients with metastatic or advanced cancer which has returned or progressed following treatment with chemotherapy, when given Pembrolizumab (MK-3475) compared to standard treatment therapies.

  Patients will receive either Pembrolizumab (MK-3475) or the investigators choice of 1 of 3 standard treatment therapies every 3 weeks, and be monitored regularly for safety and clinical and/or radiographic evidence of disease progression according to usual standards practice.

  About 466 subjects will take part in the study which will last for approximately 24 months.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2FzxVcK0hbQLbWcj8riAcEDOL1enLdLwrs6sRtw5tC6LkmyUQ-2FnV1NPSIPLwa22lnXXDaO2_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKv1OuS3sScM41A-2BCImPHPvxfQAlgQ1Dwtrc5OU62WS35jfGZ-2FaGIQfYtXFjHo8xovP3dh9wU88HhyIKcD6TgYGC41XoBzaNyVchCSVjecTUD8pSgIfuI4obbE2WzK-2FHjh2nIFsODb5yWKJq7XarTpJNcZjVgruKAJVptrEEIQ83w-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cb0abd38d4a474650091b08dafd3cd05a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638100734874088912%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=BaAkwl4xNfEREz%2B8DeI4CHXaeZI%2B9OhTzP3ad9oTqu8%3D&reserved=0

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  14/EE/1200

• Date of REC Opinion

  3 Nov 2014

• REC opinion

  Favourable Opinion