PER-003-23进行中（未招募）3 期
A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participants are eligible to be included in the study if all of the following criteria apply:
- •1.Age = 18 years (or age = regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
- •2.Capable of giving signed informed consent as described in Appendix 1, Section 10.1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •3.Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
- •4.Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1 (See Section 8.2.6).
- •5.At least one measurable target lesion per RECIST v1.1.
- •6.Adequate organ and marrow function, as defined by the following laboratory values:
- •a.Neutrophils: = 1500/µL (without myeloid growth factor support within the last 2 weeks).
- •b.Platelets: = 100 x 103/µL (without thrombopoietic stimulating agents or transfusion within the last 2 weeks).
- •c.Hemoglobin: = 9.0 g/dL (without erythropoietin or erythropoietin-stimulating agents or transfusion within the last 2 weeks).
- •d.Aspartate aminotransferase (AST): = 2.5 x upper limit of normal (ULN) without hepatic metastasis; = 5 x ULN with hepatic metastasis.
- •e.Alanine aminotransferase (ALT): = 2.5 x ULN without hepatic metastasis, = 5 x ULN with hepatic metastasis.
- •f.Total bilirubin: = 2 x ULN (Except participants with Gilbert’s syndrome).
- •g.Creatinine clearance: = 50 mL/min (calculated using the Cockcroft-Gault method).
- •7.Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing (as described in Section 8.6); if not, a new biopsy of a representative tumor lesion not previously irradiated (tumors progressing in a prior site of radiation may be considered after Sponsor consultation) must be obtained.
- •8.Contraceptive use by men and women should follow contraception guidelines as described in Appendix 5 (Section 10.5.2).
- •9.Women of childbearing potential (WOCBP, as defined in Appendix 5 [Section 10.5.1]) must have a negative serum pregnancy test.
- •10.Female participants must not be breastfeeding at the time of providing informed consent and throughout the study.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1.Underlying medical or psychiatric conditions that, in the investigator’s or sponsor’s opinion, will make the administration of study-specified therapy hazardous, including but not limited to:
- •a.Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis.
- •Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization.
- •Note: Prophylactic antibiotic treatment (eg, to prevent a urinary tract infection) is allowed.
- •b.Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization.
- •c.History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
- •d.Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
- •2.Known HER-2-positive tumor.
- •3.Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
- •Note: Participants with treated brain metastases who are clinically stable and do not require steroid therapy for at least 14 days prior to the first dose of study intervention will not be excluded.
- •4.Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
- •5.Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy.
- •6.History of trauma or major surgery within 28 days prior to randomization.
- •Note: Placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure.
- •7.Use of any live vaccines within 28 days prior to randomization.
- •8.QTc =480 msec using Fredericia QT correction formula (based on an average of triplicate recordings).
- •9.Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
- •a.Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment as listed above.
- •10.Chronic medical condition requiring the ongoing use of supra-physiologic doses of systemic corticosteroids (>10 mg/day of oral prednisone or equivalent) or systemic immunosuppressive medications.
- •11.Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell
研究者
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