Clinical Trial: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) in Subjects With Selected Cancers (INCB 24360-202 / MK-3475-037 / KEYNOTE-037/ ECHO-202)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) in Subjects With Selected Cancers (KEYNOTE-037/ ECHO-202)

Brief Summary: The purpose of this study is to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in subjects with certain cancers. This study will be conducted in 2 phases, Phase 1 and Phase 2.

Detailed Summary:
Sponsor: Incyte Corporation

Current Primary Outcome:

  • Phase 1: Number of subjects with dose limiting toxicities (DLTs) of INCB024360 in combination with MK-3475 [ Time Frame: 56 days ]
  • Phase 2: Objective response rate [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 18 months ]


Original Primary Outcome:

  • Phase 1: Number of subjects with dose limiting toxicities (DLTs) of INCB024360 in combination with MK-3475 [ Time Frame: 56 days ]
  • Phase 2: Progression free survival (PFS) [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 18 months ]


Current Secondary Outcome:

  • Progression free survival [ Time Frame: Response is measured every 9 weeks for duration of study participation which is estimated to be 18 months ]
  • Number of subjects with Adverse Events as a Measure of Safety and Tolerability of INCB024360 in combination with MK-3475 [ Time Frame: Adverse events are assessed every 3 weeks for duration of study participation which is estimated to be 18 months ]
  • Overall survival (OS) [ Time Frame: Patients are checked for survival every 12 weeks for duration of study participation which is estimated to be 18 months ]


Original Secondary Outcome:

  • Objective response rate [ Time Frame: Response is measured every 9 weeks for duration of study participation which is estimated to be 18 months ]
  • Number of subjects with Adverse Events as a Measure of Safety and Tolerability of INCB024360 in combination with MK-3475 [ Time Frame: Adverse events are assessed every 3 weeks for duration of study participation which is estimated to be 18 months ]
  • Ordinal categorical response score [ Time Frame: Response is measured every 9 weeks for duration of study participation which is estimated to be 18 months ]
  • Durability of response [ Time Frame: Response is measured every 9 weeks for duration of study participation which is estimated to be 18 months ]
  • Time to disease progression [ Time Frame: Disease progression is assessed every 9 weeks for duration of study participation which is estimated to be 18 months ]
  • Overall survival (OS) [ Time Frame: Patients are checked for survival every 12 weeks for duration of study participation which is estimated to be 18 months ]


Information By: Incyte Corporation

Dates:
Date Received: June 26, 2014
Date Started: June 2014
Date Completion: February 2019
Last Updated: May 8, 2017
Last Verified: May 2017