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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
444
IV infusion
Oral daily dosing
UC San Diego Moores Cancer Center
La Jolla, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
US Davis Cancer Center
Sacramento, California, United States
University Of Colorado Cancer Center
Aurora, Colorado, United States
University of Connecticut Health Center Carole And Ray Neag Comprehensive Cancer Center
Farmington, Connecticut, United States
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
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.
Time frame: Approximately 54 months
Phase 2: Objective Response Rate (ORR)
ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Approximately 54 months
Phase 2: Duration of Response (DOR)
Duration of response is the time from the first overall response contributing to an objective response (complete or partial response) for DLBCL to the date of death or the date of first overall response of progressive diseasemeasured (by irRECIST for solid tumors or the Lugano Classification, whichever is earliest.
Time frame: Up to 54 months
Phase 2: Progression Free Survival (PFS)
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 for DLBCL.
Time frame: Up to 54 months
Phase 2: Duration of Disease Control
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), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or better.
Time frame: Up to 54 months
Phase 2: Overall Survival (OS)
Overall survival is determined from the date of first dose until death due to any cause.
Time frame: Up to 54 months
Phase 2: Ordinal Categorical Response Score
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: 1 = Complete response per irRECIST v1.1 2 = Very good response, defined as \> 60% tumor reduction 3 = Minor response, defined as \> 30% to ≤ 60% tumor reduction 4 = Stable disease per irRECIST v1.1 5 = Progressive disease per irRECIST v1.1
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
Time frame: Up to 54 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, United States
Georgia Cancer Specialists affiliated with Northside Hospital Cancer Institute
Atlanta, Georgia, United States
The University of Chicago Medicine
Chicago, Illinois, United States
St. Francis Cancer Center
Topeka, Kansas, United States
Greater Baltimore Cancer Center
Baltimore, Maryland, United States
...and 14 more locations