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.

View Eligibility Criteria

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 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) overexpression positive 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

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

702

Study ID:

NCT05111626

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 84 Locations for this study

See Locations Near You

Mayo Clinic - Arizona
Phoenix Arizona, 85054, United States
Cancer and Blood Specialty Clinic
Downey California, 90241, United States
City of Hope National Medical Center
Duarte California, 91010, United States
University of California Los Angeles Bowyer Hematology-Oncology Clinic
Los Angeles California, 90095, United States
University of California at Irvine Medical Center
Orange California, 92868, United States
Torrance Health Association, DBA Torrance Memorial Physician Network
Redondo Beach California, 90277, United States
Translational Research in Oncology - US Inc
Santa Monica California, 90404, United States
Translational Research in Oncology US Inc, TRIO Central Pharmacy
Santa Monica California, 90404, United States
Olive View-University of California in Los Angeles Medical Center
Sylmar California, 91342, United States
PIH Health Whitter Hospital
Whittier California, 90602, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
Florida Cancer Specialists - Fort Myers
Fort Myers Florida, 33901, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, United States
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
Orlando Florida, 32804, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Summit Medical Group
Florham Park New Jersey, 07932, United States
United States Oncology Regulatory Affairs Corporate Office
Albany New York, 12208, United States
US Oncology Research Investigational Products Center
Albany New York, 12208, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10022, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
FirstHealth Outpatient Cancer Center
Pinehurst North Carolina, 28374, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Saint Lukes University Health Network
Bethlehem Pennsylvania, 18015, United States
The West Clinic, PLLC
Germantown Tennessee, 38138, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Texas Oncology - Austin Midtown
Austin Texas, 78705, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Northwest Cancer Specialists - Vancouver
Vancouver Washington, 98684, United States
Aurora Health Care Metro Inc
Milwaukee Wisconsin, 53215, United States
Cemic
Ciudad Autonoma de Buenos Aires Buenos Aires, C1431, Argentina
Centro Medico Austral
Ciudad Autónoma de Buenos Aires Distrito Federal, C1019, Argentina
Fundacion Ars Medica
San Salvador de Jujuy Jujuy, 4600, Argentina
Clinica Viedma
Viedma Río Negro, 8500, Argentina
Centro Oncologico Riojano Integral
La Rioja , F5300, Argentina
GenesisCare -North Shore (Oncology)
St Leonards New South Wales, 2065, Australia
The Queen Elizabeth Hospital
Woodville South South Australia, 5011, Australia
Ballarat Health Services
Ballarat Victoria, 3350, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Bruxelles , 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Universitair Ziekenhuis Brussel
Jette , 1090, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium
Centre Hospitalier de l Ardenne
Libramont , 6800, Belgium
Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
Fortaleza Ceará, 60430, Brazil
Personal Oncologia de Precisao e Personalizada
Belo Horizonte Minas Gerais, 30130, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal Rio Grande Do Norte, 59075, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Fundacao Pio 12 Hospital de Amor de Barretos
Barretos São Paulo, 14784, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
Sao Paulo São Paulo, 01221, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Sao Paulo São Paulo, 01308, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto São Paulo, 15090, Brazil
Instituto Coi
Rio de Janeiro , 22793, Brazil
Semmelweis Egyetem
Budapest , 1083, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest , 1097, Hungary
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
Szolnok , 5004, Hungary
Szent Borbala Korhaz
Tatabanya , 2800, Hungary
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo , 24127, Italy
Nagoya University Hospital
Nagoya-shi Aichi, 466-8, Japan
Chiba Cancer Center
Chiba-shi Chiba, 260-8, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi Fukuoka, 811-1, Japan
Gifu University Hospital
Gifu-shi Gifu, 501-1, Japan
Hyogo Cancer Center
Akashi-shi Hyogo, 673-8, Japan
Yokohama City University Medical Center
Yokohama-shi Kanagawa, 232-0, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama-shi Kanagawa, 241-8, Japan
Kansai Medical University Hospital
Hirakata-shi Osaka, 573-1, Japan
Kindai University Hospital
Osakasayama-shi Osaka, 589-8, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka, 411-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Tokyo, 135-8, Japan
Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach
Gliwice , 44-10, Poland
Przychodnia Lekarska Komed Roman Karaszewski
Konin , 62-50, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin , 20-08, Poland
Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
Siedlce , 08-11, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie
Szczecin , 71-25, Poland
LUX MED Onkologia Spzoo Szpital Szamocka
Warszawa , 01-74, Poland
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Chulabhorn Hospital
Bangkok , 10210, Thailand
Prince of Songkla Hospital
Songkhla , 90110, Thailand
Addenbrookes Hospital
Cambridge , CB2 0, United Kingdom
Ninewells Hospital and Medical School
Dundee , DD1 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

702

Study ID:

NCT05111626

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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