The purpose of this study was to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in participants with certain cancers. This study was conducted in 2 phases, Phase 1 and Phase 2.
Name: MK-3475
Description: IV infusionType: DrugPhase 1: MK-3475 + INCB024360 Phase 2: MK-3475 + INCB024360
Name: INCB024360
Description: Oral daily dosingType: DrugPhase 1: MK-3475 + INCB024360 Phase 2: MK-3475 + INCB024360
Description: An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.
Measure: Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events Time: From study start up to clinical data cut-off date of 26 Nov 2018 (approximately 54 months)Description: ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)], per modified Response Evaluation Criteria In Solid Tumors (irRECIST) v1.1 criteria for select solid tumors or modified Lugano Classification for diffuse large B-cell lymphoma (DLBCL).
Measure: Phase 2: Objective Response Rate (ORR) Time: Assessed every 9 weeks after the first dose of study treatment for the first 2 assessments (Weeks 9 and 18) then every 12 weeks thereafter until data cut-off date of 26 Nov 2018 (approximately 54 months)Description: Duration of response is the time from the first overall response contributing to an objective response (complete response or partial response) to the date of death or the date of first overall response of progressive disease (whichever is earliest).
Measure: Phase 2: Duration of Response (DOR) Time: Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeksDescription: Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification (Cheson et al 2014) for DLBCL.
Measure: Phase 2: Progression Free Survival (PFS) Time: Response is measured every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeksDescription: The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification Cheson et al 2014), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or bette
Measure: Phase 2: Duration of Disease Control Time: Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeksDescription: Ordinal categorical response score, determined by radiographic disease assessments per irRECIST v1.1. The 5-category ordinal response endpoint is determined at a given timepoint by classifying response into one of the following groups: = Complete response per irRECIST v1.1 = Very good response, defined as > 60% tumor reduction = Minor response, defined as > 30% to ≤ 60% tumor reduction = Stable disease per irRECIST v1.1 = Progressive disease per irRECIST v1.1
Measure: Phase 2: Ordinal Categorical Response Score Time: Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeksDescription: Overall survival is determined from the date of first dose until death due to any cause.
Measure: Phase 2: 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 weeksAllocation: Non-Randomized
Parallel Assignment
There is one SNP
- Phase 2 expansion: Melanoma - Documentation of V600E-activating BRAF mutation status. --- V600E ---