EUCTR2016-004529-17-ES进行中（未招募）1 期
A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED, UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION CANCER (MORPHEUS-GASTRIC CANCER)
F. Hoffman-La Roche Ltd0 个研究点目标入组 100 人开始时间: 2018年2月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •Inclusion Criteria for Stages 1 and 2
- •- Ability to comply with the study protocol, in the investigator’s judgment
- •- Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version (RECIST) v1.1
- •- Adequate hematologic and end organ function
- •- Negative HIV test at screening
- •- Negative hepatitis B surface antigen test at screening
- •- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
- •- Negative HCV antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- •- Tumor accessible for biopsy
- •- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures as outlined for each specific treatment arm
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
- •Inclusion Criteria for Stage 1
- •- Age >=18 years at the time of signing Informed Consent Form
- •- ECOG Performance Status of 0 or 1
- •- Life expectancy >3 months, as determined by the investigator
- •- Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma of gastric or gastroesophageal junction
- •- Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing
- •- Only for the 1L Cohort: patients whose tumors are without HER2 amplification documented by fluorescence in situ hybridization (FISH) or in situ hybridization (ISH) or are negative by immunohistochemistry (IHC) 0 or +1 on previously collected and assessed tumor tissue upon initial diagnosis of disease by local laboratory testing
- •Inclusion Criteria for Stage 2
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0?2
- •- Participation in the 2L Cohort during Stage 1
- •- Patients in a control arm during Stage 1: ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity, provided that Medical Monitor approval for entry into Stage 2 is obtained, or disease progression per RECIST v1.1 while receiving treatment
- •- Patients in an experimental arm during Stage 1: ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab, provided that Medical Monitor approval for entry into Stage 2 is obtained, or loss of clinical benefit as determined by the investigator while receiving treatment
- •- Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible by the investigator) because of unacceptable toxicity, disease progression per RECIST v1.1, or loss of clinical benefit as determined by the investigator
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Exclusion Criteria for Stages 1 and 2
- •- Prior treatment with any of the protocol-specified study treatments, with the exception of chemotherapy, radiotherapy, and atezolizumab given in Stage 1
- •- Patients with a signet ring cells dominant carcinoma (>50% of the tumor)
- •- Weight loss >5% within 4 weeks prior to screening
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites
- •- Uncontrolled tumor-related pain
- •- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- •- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •- History of leptomeningeal disease
- •- Active or history of autoimmune disease or immune deficiency
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •- Known clinically significant liver disease
- •- Active tuberculosis
- •- Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment
- •- Significant cardiovascular disease within 12 months prior to initiation of study treatment, or unstable arrhythmia or unstable angina within 3 months prior to initiation of study treatment
- •- Significant bleeding disorder, vasculitis, Grade >=3 hemorrhage, or significant bleeding episode from a gastrointestinal tract event within 3 months prior to initiation of study treatment
- •- History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to initiation of study treatment
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Treatment with anticoagulation with warfarin, low-molecular-weight heparin, or similar agents for therapeutic purposes
- •- History of malignancy other than gastric or gastroesophageal junction carcinoma within 2 years prior to screening
- •- History of severe allergic, anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- •- Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient to 5-FU toxicity
- •- Treatment with systemic immunostimulatory medication within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the initiation of study treatment
- •- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment
- •Exclusion Criteria for 2L Cohort, Stage 1
- •- Urinary protein is >1 + on dipstick and the required following 24-hour urine collection shows urinary protein >2000 mg
- •- Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to initiation of study treatment
- •- History of gastrointestinal perforation and/or fistulae within 6 months prior to initiation of study treatment
- •- Presence of a bowel obstruction, history or presence of inflammatory enteropathy, or extensive intestinal resection, Crohn disease, ulcerative colitis, or chronic diarrhea
- •- Uncontrolled arterial hypertension >=140/>=95 mmHg despite standard medical management
- •- Chronic therapy with non-steroidal anti-inflammatory agents
- •Exclusion Criteria for Stage 1
- •- Systemic treatment for gastric cancer within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- •- Prior treatment with T-cell co
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