The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475) versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent. The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central radiologists' review compared to paclitaxel.
Once the participant has achieved the study objective or the study has ended, the participant will be discontinued from the study and may be enrolled in an extension study to continue protocol-defined assessments and treatment. Enrollment in the extension study will be conditional on participant consent. Treatment with pembrolizumab or paclitaxel will continue until documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to discontinue the participant, participant withdraws consent, pregnancy of the participant, participant receives 35 administrations (approximately 2 years) of pembrolizumab, or administrative reasons requiring cessation of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
IV infusion
IV infusion
Beijing Cancer Hospital ( Site 0022)
Beijing, Beijing Municipality, China
Fuzhou General Hospital of Nanjing Military Command ( Site 0023)
Fuzhou, Fujian, China
The First People's Hospital of Changzhou ( Site 0024)
Changzhou, Jiangsu, China
Nanjing 81 PLA Hospital, Dept. of Oncology ( Site 0001)
Nanjing, Jiangsu, China
Jilin Province Cancer Hospital, Department of Chemotherapy ( Site 0002)
Changchun, Jilin, China
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Time frame: Up to approximately 50 months
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS as assessed by blinded independent central review will be presented.
Time frame: Up to approximately 50 months
Objective Response Rate (ORR) Per RECIST 1.1
ORR was defined as the percentage of participants in the analysis population who had 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, taking as reference the baseline sum diameters) per RECIST 1.1.
Time frame: Up to approximately 50 months
Number of Participants Who Experience an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to approximately 50 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to approximately 25 months
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Tangdu Hospital ( Site 0030)
Xi’an, Shanxi, China
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0014)
Hangzhou, Zhejiang, China
301 Hospital ( Site 0008)
Beijing, China
307 Hospital of PLA, Dept. of Oncology ( Site 0006)
Beijing, China
Peking Union Medical College Hospital ( Site 0011)
Beijing, China
...and 26 more locations