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 mFOLFOX6 chemotherapy or nivolumab
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)
Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated using the formula of Cockcroft and Gault
International Normalized Ratio (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 mFOLFOX6 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 146 Locations for this study
Phoenix Arizona, 85054, 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
Whittier California, 90603, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32224, United States
Orlando Florida, 32804, United States
Orlando Florida, 32806, United States
Baltimore Maryland, 21204, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Florham Park New Jersey, 07932, United States
Albany New York, 12208, United States
Albany New York, 12208, 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
Bethlehem Pennsylvania, 18015, 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
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
Córdoba , X5000, Argentina
La Rioja , F5300, Argentina
St Leonards New South Wales, 2065, Australia
Woodville South South Australia, 5011, Australia
Ballarat Victoria, 3350, Australia
Heidelberg Victoria, 3084, Australia
Bruxelles , 1200, Belgium
Charleroi , 5530, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Jette , 1090, Belgium
Leuven , 3000, Belgium
Libramont , 6800, Belgium
Liege , 4000, Belgium
Fortaleza Ceará, 60430, Brazil
Brasilia Distrito Federal, 70200, 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
São José do Rio Preto São Paulo, 15090, Brazil
Rio de Janeiro , 22793, Brazil
São Paulo , 05403, Brazil
London Ontario, N6A 5, Canada
Montréal Quebec, H2X 3, Canada
Quebec , G1J 1, Canada
Besançon , 25030, France
Bordeaux , 33000, France
Clermont-Ferrand cedex 1 , 63003, France
Lille Cedex , 59037, France
Limoges Cedex , 87042, France
Lyon cedex 8 , 69373, France
Paris Cedex 10 , 75475, France
Paris , 75015, France
Saint Herblain , 44800, France
Saint Priest en Jarez , 42270, France
Strasbourg cedex , 67065, France
Villejuif , 94805, France
Budapest , 1083, Hungary
Budapest , 1097, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Szolnok , 5004, Hungary
Tatabanya , 2800, Hungary
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Tel Aviv , 64239, Israel
Bergamo , 24127, Italy
Castellana Grotte , 70013, Italy
Cremona , 26100, Italy
Genova , 16132, Italy
Milano , 20133, 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
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
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 , 06591, Korea, Republic of
Seoul , 08308, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Gliwice , 44-10, Poland
Konin , 62-50, Poland
Lublin , 20-08, Poland
Siedlce , 08-11, Poland
Szczecin , 71-25, Poland
Warszawa , 01-74, Poland
Wroclaw , 50-55, Poland
Singapore , 11907, Singapore
Singapore , 16961, Singapore
Kaohsiung , 80756, Taiwan
Tainan , 70403, Taiwan
Taipei , 11217, Taiwan
Taipei , 11490, Taiwan
Bangkok , 10210, Thailand
Chiang Mai , 50200, Thailand
Chiang Rai , 57000, Thailand
Songkhla , 90110, Thailand
Cambridge , CB2 0, United Kingdom
Dundee , DD1 9, United Kingdom
Manchester , M20 4, United Kingdom
Torquay , TQ2 7, United Kingdom
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