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Active (not recruiting) Phase 3 NCT05111626

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

Phase 3 – large-scale trial before approval
Conditions: Gastric Cancer Gastroesophageal Junction Adenocarcinoma

Sponsor: Amgen

trial.available_in: БГ
Overview
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 chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.
Who can participate
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
Locations 27
Argentina (1)
Cemic
Ciudad Autonoma de Buenos Aires , Buenos Aires
Australia (1)
GenesisCare -North Shore Oncology
St Leonards , New South Wales
Belgium (1)
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels
Brazil (1)
Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
Fortaleza , Ceará
Bulgaria (1)
Complex Oncology Center - Burgas
Burgas
Canada (1)
London Health Sciences Centre
London , Ontario
Chile (1)
Centro De Estudios Clínicos Suecia SpA
Santiago , Santiago Metropolitan
China (1)
The First Affiliated Hospital of Bengbu Medical University
Bengbu , Anhui
Colombia (1)
Hospital Pablo Tobon Uribe
Medellín , Antioquia
Czech Republic (1)
Fakultni nemocnice Hradec Kralove
Hradec Králové
France (1)
Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
Amiens
Germany (1)
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin
Hong Kong (1)
Prince of Wales Hospital / CUHK
Shatin, New Territories
Hungary (1)
Semmelweis Egyetem
Budapest
Israel (1)
Rambam Health Care Campus
Haifa
Italy (1)
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona
Japan (1)
Nagoya University Hospital
Nagoya , Aichi-ken
Poland (1)
Beskidzkie Centrum Onkologii Szpital Miejski imienia Jana Pawla Drugiego
Bielsko-Biala
Romania (1)
Institutul Clinic Fundeni
Bucharest
Singapore (1)
National University Hospital
Singapore
South Korea (1)
Kyungpook National University Chilgok Hospital
Daegu
Spain (1)
Hospital Universitario Virgen del Rocio
Seville , Andalusia
Switzerland (1)
Universitaetsspital Basel
Basel
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Thailand (1)
Chulabhorn Hospital
Bangkok
United Kingdom (1)
Addenbrookes Hospital
Cambridge
United States (1)
Mayo Clinic - Arizona
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
14.03.2022
Completion date
29.01.2027
Registry ID
NCT05111626
Source
anzctr
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