EUCTR2015-000269-30-IT进行中（未招募）1 期
AN OPEN-LABEL, MULTICOHORT, PHASE II STUDY OF MPDL3280A INADVANCED SOLID TUMORS - BASKET
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 474
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.Ability to comply with protocol
- •2.Male or female, 18 years of age or older
- •3.Histologically documented advanced (i.e. stages III or IV) solid tumors that meet protocol-defined cohort specifications, with progressive disease at study entry and at least one prior line of systemic
- •anticancer therapy or for which there is no alternative therapy known to prolong survival.
- •4.Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in
- •paraffin blocks or, in exceptional cases, 15 unstained slides, with an
- •associated pathology report, for central testing. Detection of tumor in
- •the provided block needs to be confirmed by the central pathology
- •laboratory prior to study enrollment. Patients with fewer than 15
- •unstained slides available at baseline (but no fewer than 10) may be
- •eligible following discussion with the Sponsor. Only tissue from core needle, punch or excisional biopsy sample
- •collection will be accepted. For core-needle biopsy specimens, at least
- •three cores should be submitted for evaluation. Fine-needle aspiration,
- •brushing, bone tissue, and lavage samples are not acceptable
- •Patients who do not have tissue specimens meeting eligibility
- •requirements must undergo a biopsy during the screening period.
- •Acceptable samples include core needle biopsies for deep tumor tissue
- •(minimum three cores) or excisional, incisional, punch, or forceps
- •biopsies for cutaneous, subcutaneous, or mucosal lesions
- •5.Measurable disease as defined by RECIST, v1.1. (except for prostate
- •cancer and malignant pleural mesothelioma) or disease-specific criteria
- •for patients with prostate cancer (see Appendix 6) and malignant pleural
- •mesothelioma (see Appendix 7)
- •6.Eastern Cooperative Oncology group ECOG Performance Status of 0 or 1
- •7.Adequate hematologic and end organ function, defined by the
- •following laboratory results obtained within 14 days prior to the first
- •study treatment (Cycle 1, Day 1):
- •-Absolute neutrophil count (ANC) = 1500 cells/µL (without granulocyte
- •colony-stimulating factor support within 2 weeks before Cycle 1, Day 1)
- •-Lymphocyte count = 500/µL
- •-White blood cell counts > 2500/µL
- •-Platelet count = 100,000/µL (without transfusion within 2 weeks before
- •Cycle 1, Day 1)
- •-Hemoglobin = 9.0 g/dL (patients may be transfused or receive
- •erythropoyetic treatment to meet this criterion)
- •-Serum bilirubin < 1.5 × upper limit of normal (ULN), with the following
- •Patients with known Gilbert disease who have serum bilirubin level = 3
- •× ULN may be enrolled
- •-Serum albumin level >3.2 g/dl
- •-Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and
- •alkaline phosphatase = 2.5 × ULN, with the following exceptions:
- •Patients with liver involvement: AST and/or ALT = 5 × ULN
- •Patients with liver or bone metastases: alkaline phosphatase = 5 × ULN
- •-Serum creatinine = 1.5 × ULN or creatinine clearance = 30 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation
- •-International normalized ratio (INR) and activated partial
- •thromboplastin time (aPTT) = 1.5 × ULN. This applies only to patients
- •who do not receive therapeutic anticoagulation; patients receiving
- •therapeutic anticoagulation (such as low-molecular weight heparin or
- •warfarin) should be on a stable dose
- •8.Women who are not postmenopausal (= 12 months of non-therapyinduced
- 另有 3 项未显示
排除标准
- •1.Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1, with the exception of those with a negligible risk of metastasis or death
- •2.Uncontrolled tumor-related pain
- •3.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •4.Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- •5.History of treated asymptomatic or symptomatic CNS metastasis or presence of CNS metastases as determined by CT scan or MRI evaluation during screening or at prior radiographic assessments
- •6.Leptomeningeal disease
- •7. Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but not clinically stable for = 2 weeks prior to Cycle 1, Day 1
- •8.Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 3 weeks prior to initiation of study treatment, with certain exceptions
- •9.Acute toxicities from previous therapy that have not resolved to Grade = 1, except for alopecia
- •10.Pregnant and lactating women
- •11.Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
- •12.Any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
- •13.Significant cardiovascular disease within 3 months prior to Cycle 1,Day 1
- •14.Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
- •15.Severe infections within 4 weeks prior to Cycle 1, Day 1
- •16.Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day
- •17.Active tuberculosis
- •18. Positive test for HIV
- •19.Patients with a positive hepatitis B surface antigen [HBsAg] test at screening or hepatitis C
- •20.anticipation of need for a major surgical procedure during the course of the study
- •21.History of autoimmune disease, except treated/stable autoimmune hypothyroidism or controlled type 1 diabetes mellitus on a stable insulin
- •regimen. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are permitted provided
- •that they meet certain pre-specified conditions
- •22.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •23.Prior allogeneic bone marrow transplantation or prior solid organ transplantation
- •24.History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
- •25.Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study treatment or within 5 months after the last dose of atezolizumab
- •26.Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies
- •27.Treatment with systemic immunostimulatory agents or with an investigational agent within 4 weeks or five half-lives of the drug prior to Cycle 1, Day 1
- •28.Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1,or an
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