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