Esophageal Cancer Clinical Trial
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer
Summary
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.
The main objective Part 2 is to compare efficacy of bemarituzumab plus mFOLFOX6 and nivolumab to placebo plus mFOLFOX6 and nivolumab as assessed by overall survival.
Eligibility Criteria
Inclusion Criteria Part 1 and Part 2:
Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
Participant has no contraindications to nivolumab and either mFOLFOX6 or CAPOX chemotherapy as per local prescribing information. Participants in Part 1 must have no contraindications to mFOLFOX6. Participants in Part 2 with contraindications to mFOLFOX6 are permitted and may be administered the CAPOX regimen, if no contraindications for this regimen exist. Participants in Part 2 with contraindications to CAPOX are permitted and may be administered the mFOLFOX6 regimen, if no contraindications for this regimen exist
Adequate organ function as follows:
Absolute neutrophil count ≥ 1.5 x 10^9/L
Platelet count ≥ 100 x 10^9/L
Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x ULN if liver involvement)
Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement or Gilbert's disease)
Part 1 only: Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female).
Part 2 only: Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female).
INR or prothrombin time (PT) < 1.5 × ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Additional Inclusion Criteria Part 2:
No prior treatment for metastatic or unresectable disease except for a maximum of
1 dose of chemotherapy with or without nivolumab; prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment
Fibroblast growth factor receptor 2b (FGFR2b) ≥ 10% 2+/3+ tumor cells (TC) as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy.
Exclusion Criteria:
Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
Known positive human epidermal growth factor receptor 2 (HER2) status
Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
Peripheral sensory neuropathy grade 2 or higher
Clinically significant cardiac disease
Other malignancy within the last 2 years (exceptions for definitively treated disease)
Chronic or systemic ophthalmologic disorders
Major surgery or other investigational study within 28 days prior to randomization
Palliative radiotherapy within 14 days prior to randomization
Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
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There are 291 Locations for this study
Phoenix Arizona, 85054, United States
Cerritos California, 90703, United States
Downey California, 90241, United States
Duarte California, 91010, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Redondo Beach California, 90277, United States
Santa Monica California, 90404, United States
Santa Monica California, 90404, United States
Sylmar California, 91342, United States
Whittier California, 90602, United States
New Haven Connecticut, 06520, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32224, United States
Orlando Florida, 32804, United States
Orlando Florida, 32806, United States
Chicago Illinois, 60612, United States
Baltimore Maryland, 21204, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Florham Park New Jersey, 07932, United States
New York New York, 10022, United States
Stony Brook New York, 11794, United States
Pinehurst North Carolina, 28374, United States
Canton Ohio, 44718, United States
Portland Oregon, 97213, United States
Allentown Pennsylvania, 18104, United States
Charleston South Carolina, 29425, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78705, United States
Houston Texas, 77030, United States
The Woodlands Texas, 77380, United States
The Woodlands Texas, 77380, United States
Norfolk Virginia, 23502, United States
Vancouver Washington, 98684, United States
Milwaukee Wisconsin, 53215, United States
Ciudad Autonoma de Buenos Aires Buenos Aires, C1431, Argentina
La Plata Buenos Aires, 1900, Argentina
Ciudad Autónoma de Buenos Aires Distrito Federal, C1019, Argentina
San Salvador de Jujuy Jujuy, 4600, Argentina
Viedma Río Negro, 8500, Argentina
San Miguel de Tucuman Tucuman, 4000, Argentina
Buenos Aires , C1426, Argentina
Capital Federal , C1199, Argentina
Córdoba , X5000, Argentina
Córdoba , X5016, Argentina
La Rioja , F5300, Argentina
St Leonards New South Wales, 2065, Australia
Waratah New South Wales, 2298, Australia
Woodville South South Australia, 5011, Australia
Ballarat Victoria, 3350, Australia
Heidelberg Victoria, 3084, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Rankweil , 6830, Austria
Salzburg , 5020, Austria
Wiener Neustadt , 2700, Austria
Wien , 1090, Austria
Bruxelles , 1200, Belgium
Charleroi , 5530, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Jette , 1090, Belgium
Leuven , 3000, Belgium
Libramont , 6800, Belgium
Liege , 4000, Belgium
Turnhout , 2300, Belgium
Fortaleza Ceará, 60430, Brazil
Brasilia Distrito Federal, 70200, Brazil
Cachoeiro de Itapemirim Espírito Santo, 29308, Brazil
Belo Horizonte Minas Gerais, 30130, Brazil
Natal Rio Grande Do Norte, 59075, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Barretos São Paulo, 14784, Brazil
Sao Paulo São Paulo, 01221, Brazil
Sao Paulo São Paulo, 01308, Brazil
Sao Paulo São Paulo, 01508, Brazil
São José do Rio Preto São Paulo, 15090, Brazil
Rio de Janeiro , 22793, Brazil
São Paulo , 04501, Brazil
Burgas , 8000, Bulgaria
Haskovo , 6300, Bulgaria
Panagyurishte , 4500, Bulgaria
Plovdiv , 4000, Bulgaria
Sofia , 1606, Bulgaria
Sofia , 1632, Bulgaria
London Ontario, N6A 5, Canada
Toronto Ontario, M4G 2, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H3T 1, Canada
Montréal Quebec, H2X 3, Canada
Quebec , G1J 1, Canada
Santiago de Chile Santiago, 75100, Chile
Viña del Mar Valparaíso, 25205, Chile
La Serena , 17204, Chile
Santiago , 75006, Chile
Santiago , 75100, Chile
Santiago , 82414, Chile
Santiago , 83303, Chile
Beijing Beijing, 10003, China
Chongqing Chongqing, 40004, China
Lanzhou Gansu, 73005, China
Wuwei Gansu, 73300, China
Foshan Guangdong, 52800, China
Guangzhou Guangdong, 51003, China
Guangzhou Guangdong, 51018, China
Shantou Guangdong, 51503, China
Nanning Guangxi, 53002, China
Luoyang Henan, 47100, China
Wuhan Hubei, 43000, China
Changsha Hunan, 41000, China
Changsha Hunan, 41000, China
Changsha Hunan, 41001, China
Hohhot Inner Mongolia, 01001, China
Changzhou Jiangsu, 21300, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21000, China
Yangzhou Jiangsu, 22500, China
Yangzhou Jiangsu, 22500, China
Nanchang Jiangxi, 33000, China
Yinchuan Ningxia, 75000, China
Xian Shaanxi, 71006, China
Jinan Shandong, 25001, China
Jinan Shandong, 25011, China
Jining Shandong, 27200, China
Shanghai Shanghai, 20002, China
Shanghai Shanghai, 20003, China
Changzhi Shanxi, 04600, China
Chengdu Sichuan, 61004, China
Luzhou Sichuan, 64600, China
Kunming Yunnan, 65010, China
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Praha 10 , 100 3, Czechia
Praha 2 , 128 0, Czechia
Praha 4 , 140 5, Czechia
Amiens Cedex 1 , 80054, France
Besançon , 25030, France
Bordeaux , 33000, France
Brest , 29200, France
Clermont-Ferrand cedex 1 , 63003, France
Lille , 59037, France
Limoges Cedex , 87042, France
Lyon cedex 8 , 69373, France
Nice , 06189, France
Paris Cedex 10 , 75475, France
Paris Cedex 14 , 75674, France
Paris , 75015, France
Rouen Cedex , 76031, France
Saint Herblain , 44800, France
Saint Priest en Jarez , 42270, France
Strasbourg cedex , 67065, France
Toulouse Cedex 9 , 31059, France
Villejuif , 94805, France
Berlin , 13353, Germany
Dresden , 01307, Germany
Frankfurt am Main , 60488, Germany
Hamburg , 20249, Germany
Hannover , 30625, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Ludwigsburg , 71640, Germany
Mainz , 55131, Germany
Mannheim , 68167, Germany
Muenchen , 81377, Germany
Muenchen , 81675, Germany
Tuebingen , 72076, Germany
Ulm , 89081, Germany
Wolfsburg , 38440, Germany
Shatin, New Territories , , Hong Kong
Budapest , 1082, Hungary
Budapest , 1097, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Nyiregyhaza , 4400, Hungary
Szekszard , 7100, Hungary
Szolnok , 5000, Hungary
Tatabanya , 2800, Hungary
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Ramat Gan , 52620, Israel
Tel Aviv , 64239, Israel
Ancona , 60126, Italy
Bergamo , 24127, Italy
Castellana Grotte , 70013, Italy
Cremona , 26100, Italy
Firenze , 50134, Italy
Genova , 16132, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Pisa , 56126, Italy
Nagoya-shi Aichi, 466-8, Japan
Chiba-shi Chiba, 260-8, Japan
Kashiwa-shi Chiba, 277-8, Japan
Matsuyama-shi Ehime, 791-0, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Gifu-shi Gifu, 501-1, Japan
Sapporo Hokkaido, 060-8, Japan
Akashi-shi Hyogo, 673-8, Japan
Kobe-shi Hyogo, 650-0, Japan
Yokohama-shi Kanagawa, 232-0, Japan
Yokohama-shi Kanagawa, 241-8, Japan
Niigata-shi Niigata, 951-8, Japan
Hirakata-shi Osaka, 573-1, Japan
Osaka-shi Osaka, 541-8, Japan
Osakasayama-shi Osaka, 589-8, Japan
Suita-shi Osaka, 565-0, Japan
Kitaadachi-gun Saitama, 362-0, Japan
Sunto-gun Shizuoka, 411-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Koto-ku Tokyo, 135-8, Japan
Daegu , 41404, Korea, Republic of
Daejeon , 35015, Korea, Republic of
Goyang-si Gyeonggi-do , 10408, Korea, Republic of
Jeonju-si, Jeollabuk-do , 54907, Korea, Republic of
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 08308, Korea, Republic of
Bielsko-Biala , 43-30, Poland
Gliwice , 44-10, Poland
Konin , 62-50, Poland
Lublin , 20-08, Poland
Olsztyn , 10-22, Poland
Siedlce , 08-11, Poland
Skorzewo , 60-18, Poland
Szczecin , 71-25, Poland
Warszawa , 01-74, Poland
Warszawa , 02-03, Poland
Warszawa , 02-17, Poland
Wroclaw , 50-55, Poland
Braga , 4710-, Portugal
Guimaraes , 4835-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Matosinhos , 4464-, Portugal
Porto , 4100-, Portugal
Porto , 4200-, Portugal
Bucharest , 02232, Romania
Cluj Napoca , 40001, Romania
Cluj-Napoca , 40000, Romania
Craiova , 20054, Romania
Iasi , 70048, Romania
Timisoara , 30023, Romania
Singapore , 11907, Singapore
Singapore , 16858, Singapore
Sevilla Andalucía, 41013, Spain
Oviedo Asturias, 33011, Spain
Santander Cantabria, 39008, Spain
Barcelona Cataluña, 08003, Spain
Barcelona Cataluña, 08035, Spain
Hospitalet de Llobregat Cataluña, 08908, Spain
Elche Comunidad Valenciana, 03203, Spain
Valencia Comunidad Valenciana, 46010, Spain
A Coruña Galicia, 15006, Spain
Pamplona Navarra, 31008, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Chur , 7000, Switzerland
Geneve , 1205, Switzerland
Zurich , 8038, Switzerland
Zurich , 8091, Switzerland
Kaohsiung , 80756, Taiwan
Taichung , 40447, Taiwan
Tainan , 70403, Taiwan
Taipei , 11217, Taiwan
Taipei , 11490, Taiwan
Bangkok , 10210, Thailand
Bangkok , 10700, Thailand
Chiang Mai , 50200, Thailand
Chiang Rai , 57000, Thailand
Songkhla , 90110, Thailand
Cambridge , CB2 0, United Kingdom
Coventry , CV2 2, United Kingdom
Dundee , DD1 9, United Kingdom
London , SE1 9, United Kingdom
Manchester , M20 4, United Kingdom
Northwood , HA6 2, United Kingdom
Torquay , TQ2 7, United Kingdom
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