A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined With Nivolumab Versus Nivolumab Alone in Subjects With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The primary objective of this study is to evaluate and compare the efficacy of andecaliximab (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or GEJ which have progressed on at least 1 prior systemic therapy or line of treatment for unresectable/metastatic disease
- •Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1
- •Measurable disease according to Response Criteria in Solid Tumors (RECIST) v1.1
- •Tumor sites that can be accessed for repeat biopsies
- •Archival tumor tissue, preferably obtained from the most recent available biopsy; there must be adequate tissue for a Cochran-Mantel Haenszel (CMH) test stratified by programmed death ligand 1 (PD-L1) stratification test, as assessed by central pathologist
- •Individuals not receiving anticoagulant medication must have an international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin (aPTT) ≤ 1.5 x upper limit of normal (ULN)
- •Required baseline laboratory data as outlined in protocol
排除标准
- •Individuals who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma
- •Radiotherapy within 28 days of randomization
- •Uncontrolled intercurrent illness as outlined in protocol
- •History of a concurrent or second malignancy except for those outlined in protocol
- •Major surgery, within 28 days of first dose of study drug
- •Known positive status for human immunodeficiency virus (HIV)
- •Known acute or chronic-active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •Chronic daily treatment with oral corticosteroids (dose of > 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
- •Known or suspected central nervous system metastases
- •Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of randomization
- •Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics
- •Current or history of pneumonitis or interstitial lung disease
- •Active known or suspected autoimmune disease with exceptions noted in protocol.
- •History of bone marrow, stem cell, or allogenic organ transplantation
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Andecaliximab + Nivolumab
Andecaliximab 800 mg plus nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
干预措施: Andecaliximab (Drug)
Andecaliximab + Nivolumab
Andecaliximab 800 mg plus nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
干预措施: Nivolumab (Drug)
Nivolumab
Nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
干预措施: Nivolumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 41 weeks
ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Progression Free Survival (PFS)(Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months)
- Overall Survival (OS)(Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 months)
- Duration of Response (DOR)(Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months)
- Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)(Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months)
- Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities(Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months)