Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)
|ClinicalTrials.gov Identifier: NCT03019588|
Recruitment Status : Active, not recruiting
First Posted : January 12, 2017
Last Update Posted : April 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Neoplasms Gastroesophageal Junction Adenocarcinoma||Biological: Pembrolizumab Drug: Paclitaxel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine|
|Actual Study Start Date :||February 16, 2017|
|Estimated Primary Completion Date :||August 17, 2019|
|Estimated Study Completion Date :||June 29, 2020|
Experimental: Pembrolizumab 200 mg
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
Other Name: MK-3475
Active Comparator: Paclitaxel 80 mg/m^2
Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
- Overall Survival (OS) [ Time Frame: Up to 2 years ]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 will be censored at the date of the last follow-up.
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to 2 years ]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.
- Objective Response Rate (ORR) per RECIST 1.1 [ Time Frame: Up to 2 years ]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.
- Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to 27 months ]An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study treatment, whether or not considered related to the use of study treatment.
- Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to 2 years ]An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study treatment, whether or not considered related to the use of study treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019588
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|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|