In this study, Chinese participants with MSI-H or dMMR advanced colorectal cancer will be assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for treatment. There is no hypothesis testing for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Intravenous (IV) infusion
85 mg/m\^2 given as an intravenous infusion (IV) on Day 1 in each 14-day cycle (Q2W) as part of the mFOLFOX6 regimen
400 mg/m\^2 given as an IV on Day 1 Q2W as part of the mFOLFOX6 and FOLFIRI regimens
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) For All Participants
PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥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 ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by BICR will be reported for all participants.
Time frame: Up to approximately 77 months
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) For RAS Wild-type Participants
PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥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 ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by BICR will be reported for RAS wild-type participants .
Time frame: Up to approximately 77 months
Overall Survival (OS) For All Participants
OS is defined as the time from randomization to death due to any cause. The OS will be reported for all participants.
Time frame: Up to approximately 77 months
Overall Survival (OS) For RAS Wild-type Participants
OS is defined as the time from randomization to death due to any cause. The OS will be reported for RAS wild-type participants.
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400 mg/m\^2 given as an IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for a total dose of 2400 mg/m\^2 Q2W as part of the mFOLFOX6 and FOLFIRI regimens
180 mg/m\^2 IV on Day 1 Q2W as part of the FOLFIRI regimen
IV infusion
IV infusion
Beijing Cancer hospital-Digestive Oncology ( Site 0001)
Beijing, Beijing Municipality, China
RECRUITINGBeijing Peking Union Medical College Hospital-Medical Oncology ( Site 0011)
Beijing, Beijing Municipality, China
COMPLETEDTianjin Medical University Cancer Institute and Hospital-Gastric oncology ( Site 0019)
Tianjin, Beijing Municipality, China
COMPLETEDThe First Affiliated Hospital of Chongqing Medical University ( Site 0051)
Chongqing, Chongqing Municipality, China
RECRUITINGChongqing University Cancer Hospital-Medical Oncology ( Site 0012)
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Provincial Cancer Hospital ( Site 0009)
Fuzhou, Fujian, China
RECRUITINGSun Yat-sen University Cancer Center ( Site 0047)
Guangzhou, Guangdong, China
RECRUITINGGuangdong Provincial People's Hospital ( Site 0035)
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital, Sun Yat-sen University ( Site 0014)
Guangzhou, Guangdong, China
RECRUITINGThe Sixth Affiliated Hospital of Sun Yat-sen University-Oncology ( Site 0048)
Guangzhou, Guangdong, China
RECRUITING...and 22 more locations
Time frame: Up to approximately 77 months
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) For All Participants
ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage for all participants who experience CR or PR as assessed by BICR will be presented.
Time frame: Up to approximately 77 months
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) For RAS Wild-type Participants
ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage for RAS wild-type participants who experience CR or PR as assessed by BICR will be presented.
Time frame: Up to approximately 77 months
Number of Participants Who Experience at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 77 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 77 months