A Phase 1b/2, Open-label, Dose Escalation Study of Entinostat in Combination With Pembrolizumab in Patients With Non-small Cell Lung Cancer, With Expansion Cohorts in Patients With Non-small Cell Lung Cancer, Melanoma, and Mismatch Repair-Proficient Colorectal Cancer

Trial Profile

A Phase 1b/2, Open-label, Dose Escalation Study of Entinostat in Combination With Pembrolizumab in Patients With Non-small Cell Lung Cancer, With Expansion Cohorts in Patients With Non-small Cell Lung Cancer, Melanoma, and Mismatch Repair-Proficient Colorectal Cancer

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Entinostat (Primary) ; Pembrolizumab (Primary)
  • Indications Colorectal cancer; Malignant melanoma; Non-small cell lung cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ENCORE 601; KEYNOTE 142
  • Sponsors Syndax Pharmaceuticals
  • Most Recent Events

    • 10 Aug 2017 According to a Syndax Pharmaceuticals media release, advancement of ENCORE 601 cohort of NSCLC patients naive to PD-(L)1 therapy to the second stage of the trial is expected by year end.The pre-specified objective response threshold to advance this cohort into the second stage of the phase 2 trial has been revised to 4 responses out of 17 versus the previous benchmark of 3 responses out of 13.
    • 10 Aug 2017 According to a Syndax Pharmaceuticals media release, the company expects to present data from stage one of the NSCLC cohorts, as well as biomarker data from the melanoma cohort, at the Society of Immunotherapy of Cancer (SITC) Annual Meeting in the fall, and the full trial data from both the refractory NSCLC and melanoma cohorts at a medical congress in the first half of 2018.
    • 10 Aug 2017 According to a Syndax Pharmaceuticals media release, the company announced that the first patient has been dosed in the ENCORE 601 cohort enrolling microsatellite stable colorectal cancer (CRC) patients and employs a Simon two-stage design.A decision on whether to advance to the second stage of the CRC cohort is expected in the first half of 2018.
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