SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT02178722
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
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.
Name: MK-3475
Description: IV infusionType: Drug
Phase 1: MK-3475 + INCB024360 Phase 2: MK-3475 + INCB024360
Name: INCB024360
Description: Oral daily dosingType: Drug
Phase 1: MK-3475 + INCB024360 Phase 2: MK-3475 + INCB024360
Primary Outcomes
Measure: Phase 1: Number of subjects with dose limiting toxicities (DLTs) of INCB024360 in combination with MK-3475
Time: 56 days
Measure: Phase 2: Objective response rate
Time: Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks
Secondary Outcomes
Measure: Progression free survival
Time: Response is measured every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks
Measure: Number of subjects with Adverse Events as a Measure of Safety and Tolerability of INCB024360 in combination with MK-3475
Time: Adverse events are assessed every 3 weeks for duration of study participation which is estimated to be 27 months
Measure: Overall survival (OS)
Time: Patients are checked for survival every 12 weeks for duration of study participation which is estimated to be a minimum of 18 weeks
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
- Phase 2 expansion: Melanoma
- Documentation of V600E-activating BRAF mutation status. --- V600E ---
HPO Nodes