The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
INCAGN02385 administered intravenously
INCAGN02390 administered intravenously
INCMGA00012 administered intravenously
The Angeles Clinic and Research Institute
Los Angeles, California, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Time frame: up to 1148 days
Phase 1: Number of Participants With Any ≥Grade 3 TEAE
The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE reported either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Time frame: up to 1148 days
Phase 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (v1.1).
Time frame: up to 325 days
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H Lee Moffitt Cancer Center and Research
Tampa, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Cancer Center For Blood Disorders A Division of American Oncology Partners P.A
Bethesda, Maryland, United States
Washington University
St Louis, Missouri, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
Nyu Langone Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Carolina Bio Oncology
Huntersville, North Carolina, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States
...and 7 more locations
Phase 2: Duration of Response (DOR)
DOR was defined as the time from the earliest date of disease response (CR or PR) until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death from any cause, if it occurred sooner than progression.
Time frame: up to 325 days
Phase 2: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with CR, PR, or stable disease (SD) as best on-study response on or after Day 56.
Time frame: up to 325 days beyond Day 56
Phase 2: Progression-free Survival (PFS)
PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease per RECIST v1.1, or death due to any cause.
Time frame: up to 325 days
Phase 2: Number of Participants With Any TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Time frame: up to 415 days
Phase 2: Number of Participants With Any ≥Grade 3 TEAE
The severity of AEs was assessed using CTCAE version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Time frame: up to 415 days
Phase 1: ORR
ORR was defined as the percentage of participants with a CR or PR, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1.
Time frame: up to 1058 days
Phase 1: DOR
DOR was defined as the time from the earliest date of disease response (CR or PR) until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death from any cause, if it occurred sooner than progression.
Time frame: up to 1058 days
Phase 1: DCR
DCR was defined as the percentage of participants with CR, PR, or SD as best on study response and or after Day 56.
Time frame: up to 1058 days beyond Day 56
Phase 1: PFS
PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease per RECIST v1.1, or death due to any cause.
Time frame: up to 1058 days