Kurzfassung

In the context of a multinational, multi-center, randomized, controlled, partly-blinded, biomarker-selected, clinical Phase III test, the efficacy of MK-3475 (Pembrolizumab) as mono therapy and in combination with Cisplatin + 5- Fluorouracil against placebo + Cisplatin + 5-Fluorouracil will be evaluated as first-line therapy in patients with an adenocarcinom of the stomach or the gastro-esophageal transition. The procedure and further details of the clinical trial are carried out according to...In the context of a multinational, multi-center, randomized, controlled, partly-blinded, biomarker-selected, clinical Phase III test, the efficacy of MK-3475 (Pembrolizumab) as mono therapy and in combination with Cisplatin + 5- Fluorouracil against placebo + Cisplatin + 5-Fluorouracil will be evaluated as first-line therapy in patients with an adenocarcinom of the stomach or the gastro-esophageal transition. The procedure and further details of the clinical trial are carried out according to the test protocol 062. The planned number of according to protocol completed patients in this center is expected to be 4.  The investigations are expected to begin in the third quarter of 2015. The recruitment time is expected to end in the third quarter of 2017. The clinical trial is expected to be completed by the end of the second quarter of 2019.
 
This is a randomized, active-controlled, multi-site, partially blinded, trial of pembrolizumab,
or pembrolizumab+cisplatin+5-fluorouracil (5-FU) versus placebo+cisplatin+5-FU, as firstline
treatment in programmed death-ligand 1 (PD-L1) positive, human epidermal growth
factor receptor 2 (HER2/neu) negative subjects with advanced gastric or gastroesophageal
junction (GEJ) adenocarcinoma.
Approximately 750 subjects will be randomized to compare the efficacy and safety of
pembrolizumab or pembrolizumab+cisplatin +5-FU versus placebo+cisplatin+5-FU as firstline
treatment. Although use of 5-FU infusion is preferred, capecitabine may be used
according to local guidelines at the investigator’s discretion. Investigator decision regarding
the type of comparator used (5-FU or capecitabine) must be determined prior to
randomization in the trial. Subjects should continue on the fluoropyrimidine chosen prior to
randomization throughout the study. Exceptions may be permitted after consultation with the
Sponsor. Study treatment in all arms will begin on Day 1 of each 3-week dosing cycle.
Subjects will be randomized in a 1:1:1 ratio among the three treatment arms  
(stratified by geographic region, disease status, and fluoropyrimidine treatment (see
Section 5.4 Stratification for more details).
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