jRCT2031210669进行中（未招募）不适用
A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen K.K.
- 入组人数
- 528
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 100age old under（—）
- 性别
- All
入选标准
- •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 mFOLFOX
- •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] x Mass [kg]/[72 x 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] x Mass [kg]/[72 x Creatinine mg/dL]) (x 0.85 if female).
- •INR or prothrombin time (PT) < 1.5 x 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.
排除标准
- •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
- •6.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
研究者
相似试验
进行中（未招募）
不适用
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) OverexpressionjRCT2031220049Amgen K.K.516
招募中
1 期
Bemarituzumab plus Chemotherapy and Nivolumab versus Chemotherapy and Nivolumab Alone (FORTITUDE-102)Gastric and Gastroesophageal Junction Cancer With FGFR2b OverexpressionMedDRA version: 21.1Level: PTClassification code: 10017758Term: Gastric cancer Class: 100000004864CTIS2023-505458-16-00Amgen Inc.528
进行中（未招募）
1 期
Bemarituzumab plus Chemotherapy and Nivolumab versus Chemotherapy and Nivolumab Alonentreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b OverexpressionMedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.1Level: LLTClassification code 10084227Term: Gastroesophageal junction cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-003477-61-HUAmgen Inc.702
招募中
3 期
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction CancerGastric Cancer , Gastroesophageal Junction AdenocarcinomaJPRN-jRCT2031210669Kaneda Hirokazu528
进行中（未招募）
1 期
Bemarituzumab plus Chemotherapy and Nivolumab versus Chemotherapy and Nivolumab AloneEUCTR2021-003477-61-ESAmgen Inc.702