A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).
Pembrolizumab (200 mg) or placebo will be administered intravenously [IV] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy for the global cohort will either be FP (80 mg/m^2 cisplatin administered IV on Day 1 of each 3-week cycle and 800 mg/m^2 5-fluorouracil [5-FU] administered IV on Days 1-5 of each 3-week cycle) or CAPOX (1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week cycle). A Japan cohort will receive SOX chemotherapy consisting of S-1 (tegafur, 5-chloro-2,4-dihydroxypyridine [CDHP], and potassium oxonate [Oxo]) administered orally BID according to Body Surface Area (BSA) on Days 1-14 of each 3-week cycle and oxaliplatin (130 mg/m^2) administered IV on Day 1 each 3-week cycle.
Inclusion Criteria:
Inclusion criteria include, but are not limited to:
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
Los Angeles, California 90095, United States
Orange, California 92868, United States
Miami, Florida 33136, United States
Middletown, New Jersey 07748, United States
Harrison, New York 10604, United States
Philadelphia, Pennsylvania 19124, United States
Sioux Falls, South Dakota 57104, United States
Roanoke, Virginia 24014, United States
Rio de Janeiro, 20231-050, Brazil
Shanghai, Anhui 200080, China
Beijing, Beijing Municipality 100071, China
Shanghai, Shanghai Municipality 200032, China
Ürümqi, Xinjiang 830001, China
Saint-Herblain, Val-de-Marne 44805, France
Tübingen, Baden-Wurttemberg 72076, Germany
Dresden, Saxony 01307, Germany
Ohta, Gunma 373-8550, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Kitaadachi-gun, Saitama 362-0806, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Osaka, 540-0006, Japan
Wroclaw, Lower Silesian Voivodeship 50-556, Poland
Lublin, Lublin Voivodeship 20-080, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Gdynia, Pomeranian Voivodeship 81-519, Poland
Kościerzyna, Pomeranian Voivodeship 83-400, Poland
Bielsko-Biala, Silesian Voivodeship 43-300, Poland
Ufa, Baskortostan, Respublika 450054, Russia
Chelyabinsk, Chelyabinsk Oblast 454087, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Saint Petersburg, Sankt-Peterburg 198255, Russia
Oviedo, Principality of Asturias 33011, Spain
Ankara, 06200, Turkey (Türkiye)
Kryviy Rih, Dnipropetrovsk Oblast 50048, Ukraine
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine
Kharkiv, Kharkiv Oblast 61070, Ukraine
Lviv, Lviv Oblast 79031, Ukraine
London, London, City of NW1 2PG, United Kingdom
London, London, City of SW17 0QT, United Kingdom