The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil \[FP regimen\] or oxaliplatin combined with capecitabine \[CAPOX regimen\]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult Chinese participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).
The China extension study will include participants previously enrolled in China in the global study for MK-3475-859 (NCT03675737) plus those enrolled during the China extension enrollment period. A total of approximately 231 Chinese participants will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Administered as an IV infusion on Day 1 Q3W
Administered as an IV infusion on Day 1 Q3W
Administered as a continuous IV infusion on Days 1-5 Q3W
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Time frame: Up to approximately 65 months
Progression-free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Time frame: Up to approximately 65 months
Objective Response Rate (ORR)
ORR was defined as the percentage of participants who have 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 lesions, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by BICR.
Time frame: Up to approximately 65 months
Duration of Response (DOR)
DOR is determined by disease assessment and is defined as the time from first response (CR or PR) to disease progression, or death from any cause, whichever occurs first.
Time frame: Up to approximately 65 months
Percentage of Participants Experiencing Adverse Events (AEs)
Percentage of participants experiencing an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment.
Time frame: Up to approximately 65 months
Percentage of Participants Discontinuing Study Drug Due to AEs
Percentage of participants discontinuing study treatment due to an AE.
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Administered as an IV infusion on Day 1 Q3W
Administered orally BID on Days 1 to 14 Q3W
Administered as an IV infusion on Day 1 Q3W
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital ( Site 2425)
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital ( Site 2410)
Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital ( Site 2414)
Fuzhou, Fujian, China
900 Hospital of the Joint ( Site 2418)
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 2430)
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University ( Site 2447)
Xiamen, Fujian, China
Guangdong General Hospital ( Site 2431)
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital ( Site 2442)
Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 2401)
Harbin, Heilongjiang, China
...and 18 more locations
Time frame: Up to approximately 36 months