The purpose of this China extension study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in adult Chinese participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.
The China extension study will include participants previously enrolled in China in the global study for MK-4280A-007 (NCT05064059) plus those enrolled during the China extension enrollment period. A total of approximately 94 Chinese participants will be enrolled. As of Amendment 3 of the supplemental statistical analysis plan, patient reported outcomes will no longer be secondary outcome measures of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
Oral
Oral
The Second Affiliated Hospital of Anhui Medical University ( Site 1179)
Hefei, Anhui, China
Chongqing Cancer Hospital ( Site 1151)
Chongqing, Chongqing Municipality, China
Fujian Province Cancer Hospital ( Site 1178)
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center ( Site 1150)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 1154)
Guangzhou, Guangdong, China
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 26 months
Progression-Free Survival (PFS) According Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Time frame: Up to approximately 26 months
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
ORR was defined as the percentage of participants who achieved a 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 lesion) per RECIST 1.1 as assessed by BICR
Time frame: Up to approximately 26 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
For participants who demonstrate confirmed CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions), duration of response was defined as the time from the first documented evidence of CR or PR until progressive disease (PD) or death due to any cause. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation.
Time frame: Up to approximately 26 months
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE was 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.
Time frame: Up to approximately 20 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was 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. The number of participants who discontinue study treatment due to an AE is presented.
Time frame: Up to approximately 17 months
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The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)
Nanning, Guangxi, China
Hainan General Hospital ( Site 1177)
Haikou, Hainan, China
Wuhan Union Hospital Cancer Center ( Site 1162)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 1152)
Wuhan, Hubei, China
...and 14 more locations