Phase I study:MK1454+/-Pembrolizumab-Advanced Solid Tumors/Lymphomas

• Research type

  Research Study

• Full title

  Phase 1 Open Label, Multicenter Study of MK-1454 Administered by Intratumoral Injection as Monotherapy and in Combination with Pembrolizumab for Patients with Advanced/Metastatic Solid Tumors or Lymphomas

• IRAS ID

  218207

• Contact name

  Kevin Harrington

• Contact email

  Kevin.Harrington@icr.ac.uk

• Sponsor organisation

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

• Eudract number

  2016-003160-40

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Summary of Research
  Merck Sharp & Dohme (MSD) is developing MK-1454, a Stimulator of Interferon Genes (STING) agonist to treat various cancers. MK-1454 is a cyclic dinucleotide STING agonist with activity across species.
  Data in animal models show that STING agonists delivered directly into tumours lead to complete tumour regression or significant growth inhibition. They can also induce immune-mediated clearance of non-injected tumours and therefore have potential as cancer therapeutics.
  Pembrolizumab is a potent and highly selective humanized monoclonal antibody developed to increase the immune attack on cancers. The mechanism of action of MK-1454 suggests that it could be effective either alone or in combination with pembrolizumab.
  Combination of MK-1454 with pembrolizumab may be effective in participants who did not respond well to pembrolizumab or are predicted to be poor responders based on tumour PD-L1 expression.
  This Phase I study will test MK-1454 for the first time in humans and will evaluate the safety, efficacy and tolerability of MK-1454 by itself or when combined with pembrolizumab in participants with advanced or spreading (metastatic) solid tumours or lymphomas. Increasing doses of MK-1454 will be tested to determine the optimum dose which can be used safely to have an effect without causing serious side effects.
  Approximately 80 participants, older than 18, will be allocated to one of two treatment arms: MK-1454 alone (Arm 1) or MK-1454 in combination with pembrolizumab (Arm 2). Arm 1 participants who have disease progression may cross over onto Arm 2 provided they meet eligibility criteria.
  Participants will visit the clinic approximately 37 times during the study. During screening and treatment, participants will be required to provide a tumour tissue sample, which will be tested for certain cancer markers.
  The study is funded by MSD and will take place at one study centre in the UK.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5BcbW9wgc64X2JjNxW-2BqMpAMLGuzSnZ5XsXicPnRvvAN3KMyg2skZb-2FBT8DKggMw35TDbLXwe8TnDr60hgSAMtT6-pZu_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJM6MSekvz3dpriONcbAAsSIC8CmJZtknPSvgRCgo-2B0LNLnVbYCiV-2Bvw44MbfDMstfoZRRIcQROwbQS-2B5kaPrCBUjzBJnxfuR7kb1X2t7FXOfTwswO8eY7E8uysFSSLkmx2U3gwjSUqlMJAXAYQAIeqTyQD4JYtP-2BZUbYJDQHmUPQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C0f28a8a58b5841046d9c08db424f1221%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638176679593499853%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=kY93IL5ewm%2BxVBuo066h%2FcDnHUUTkjfhVP4DVu7%2BrNs%3D&reserved=0

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  17/EE/0021

• Date of REC Opinion

  15 Feb 2017

• REC opinion

  Further Information Favourable Opinion