EUCTR2016-001402-41-DE进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Age =18 years
- •2) 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
- •3) Eastern Cooperative Oncology Group (ECOG) = 1
- •4) Measurable disease according to RECIST v1.1
- •5) Tumor sites that can be accessed for repeat biopsies
- •6) Archival tumor tissue, preferably from the most recent available biopsy; there must be adequate tissue for a PD-L1 stratification test, as assessed by central pathologist
- •7) All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline
- •8) Subjects 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). The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the subject has been on stable dose of anticoagulants for at least 1 week at the time of randomization
- •9) Adequate hematologic function
- •a) neutrophils = 1.5 x 10^9/L
- •b) platelets = 100 x 10^9/L
- •c) hemoglobin = 9 g/dL
- •10) Adequate hepatic function
- •a) Direct or total bilirubin = 1.5 x ULN
- •b) ALT and AST = 2.5 x ULN
- •11) Creatinine clearance (CLcr) = 60 mL/min, estimated based on the Cockroft-Gault formula or measured based on 24 hour urine collection or other reliable method
- •12) For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the screening visit throughout the study treatment period, for 90 days following the last dose of GS-5745 and at least 5 months after the last dose of nivolumab, unless the subject chooses continuous heterosexual abstinence as a lifestyle-choice (see Appendix 4 of the protocol)
- •13) For male subjects of reproductive potential having intercourse with females of childbearing potential, willingness to use a protocol recommended method of contraception and to refrain from sperm donation from the start of study drug, throughout the study treatment period, and for 90 days after administration of the last dose of GS-5745 or nivolumab (see Appendix 4 of the protocol)
- •14) Breastfeeding females must agree to discontinue nursing before study drug administration
- •15) In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject’s cancer
- •16) Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions
- •17) Evidence of a signed informed consent prior to implementation of any protocol specific procedure
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1) Subjects who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma
- •2) Radiotherapy within 28 days of randomization; subjects given palliative radiotherapy to peripheral sites (eg, bone metastasis) may enter the study before 28 days have elapsed provided the radiated sites do not contain lesions which may be used to evaluate response, and must have recovered from any acute, reversible effects
- •3) Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, active gastrointestinal bleeding, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
- •4) History of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder cancer; asymptomatic prostate cancer without known metastatic disease, with no requirement for therapy or requiring only hormonal therapy, and with normal prostate-specific antigen for = 1 year prior to randomization; adequately treated Stage 1 or 2 cancer currently in complete remission; or any other cancer that has been in complete remission for = 5 years
- •5) Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy), within 28 days of first dose of study drug
- •6) Known positive status for human immunodeficiency virus (HIV)
- •7) Known acute or chronic-active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •8) Chronic daily treatment with oral corticosteroids (dose of > 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed
- •9) Known or suspected central nervous system metastases
- •10) Known alcohol or drug abuse or any other medical or psychiatric condition which contraindicates participation in the study
- •11) Documented myocardial infarction or unstable/uncontrolled cardiac disease (ie, unstable angina, congestive heart failure [New York Heart Association > Class II]) within 6 months of randomization
- •12) Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics
- •13) Pregnant or breastfeeding women (pregnancy needs to be excluded by testing of beta-human chorionic gonadotropin [ß-hCG])
- •14) Experimental medical treatment within 28 days prior to randomization
- •15) Known hypersensitivity to GS-5745 or nivolumab or excipients or to Chinese hamster ovary cell products or to recombinant human or humanized antibodies
- •16) Prior treatment with anti-CTLA-4 agents (ipilimumab), anti-PD-1 or anti-PD-L1 agents (pembrolizumab, nivolumab), anti-PD-L2 agents, anti-MMP agents, or other immunomodulatory therapies
- •17) Previous severe hypersensitivity reaction to treatment with another monoclonal antibody Therapy
- •18) Subject is expected to require any other form of systemic or localized antineoplastic therapy while on study
- •19) Prior therapy with anti-tumor vaccines or other immuno-modulatory antitumor agents
- •20) Current or history of pneumonitis or interstitial lung disease
- •21) Active known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus,
研究者
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