The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
302
400 mg or 200 mg pembrolizumab administered via IV infusion.
Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.
Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR will be presented.
Time frame: Up to approximately 50 months
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
DOR is defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time frame: Up to approximately 50 months
Progression-Free Survival (PFS) per RECIST 1.1 as assessed by BICR
PFS is defined as the time from randomization (or first dose) to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Time frame: Up to approximately 50 months
PFS per RECIST 1.1 as assessed by Investigator
PFS is defined as the time from randomization (or first dose) to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator will be presented.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion
800 mg MK-4830 administered via IV infusion
Mid Florida Cancer Center ( Site 1519)
Orange City, Florida, United States
University Cancer & Blood Center, LLC ( Site 1521)
Athens, Georgia, United States
University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P
Chicago, Illinois, United States
Icahn School of Medicine at Mount Sinai ( Site 1528)
New York, New York, United States
Hematology Oncology Associates of Rockland ( Site 1525)
Nyack, New York, United States
UPMC Hillman Cancer Center ( Site 1516)
Pittsburgh, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer Center ( Site 1576)
Germantown, Tennessee, United States
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)
Nashville, Tennessee, United States
UT Southwestern Medical Center ( Site 1551)
Dallas, Texas, United States
Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)
Temple, Texas, United States
...and 99 more locations
Time frame: Up to approximately 50 months
ORR per RECIST 1.1 as assessed by Investigator
ORR is defined as the percentage of participants who have a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by investigator will be presented.
Time frame: Up to approximately 50 months
DOR per RECIST 1.1 as assessed by Investigator
DOR is defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until PD or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be presented.
Time frame: Up to approximately 50 months
Overall Survival (OS)
OS is defined as the time from randomization (or first dose) to death due to any cause. OS will be presented.
Time frame: Up to approximately 50 months
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants with an AE will be presented.
Time frame: Up to approximately 50 months
Number of Participants Discontinuing Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants that discontinue study treatment due to an AE will be presented.
Time frame: Up to approximately 50 months