A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Liver Tumors Alone and in Combination With Systemic Pembrolizumab (MASTERKEY-318)

Trial Profile

A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Liver Tumors Alone and in Combination With Systemic Pembrolizumab (MASTERKEY-318)

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 14 Feb 2018

At a glance

  • Drugs Pembrolizumab (Primary) ; Talimogene laherparepvec (Primary)
  • Indications Adenocarcinoma; Breast cancer; Colorectal cancer; Gastric cancer; Liver cancer; Liver metastases; Malignant melanoma; Non-small cell lung cancer; Oesophageal cancer; Renal cell carcinoma; Squamous cell cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms MASTERKEY-318
  • Sponsors Amgen
  • Most Recent Events

    • 08 Feb 2018 Study protocol amended with inclusion of additional combination arm of Talimogene Laherparepvec and Pembrolizumab (treatment arms changed from 1 to 2).This change was accompanied by addition of Merck Sharp & Dohme Corp as collaborator, phase change from 1 to 1b/2, change in interventional assignment from single group to sequential,addition of acronym MASTERKEY-318, revision of primary, secondary endpoints, inclusion and exclusion criteria and change in offical title and target sample size.
    • 08 Feb 2018 Planned patient number changed from 100 to 244.
    • 20 Jan 2018 Results from cohort 1 and 2 of group A (n=14) presented at the 2018 Gastrointestinal Cancers Symposium
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