AN OPEN-LABEL, MULTICOHORT, PHASE II STUDY OF MPDL3280A IN ADVANCED SOLID TUMORS - Basket

Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.0 个研究点目标入组 250 人开始时间: 2015年4月27日最近更新: 2019年12月10日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 250

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1.Ability to comply with protocol
•2.Male or female, 18 years of age or older
•3.Histologically- or cytologically-documented solid tumors that are advanced and have progressed following at least one line of prior systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator
•4.Representative formalin-fixed paraffin-embedded 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) and disease-specific criteria for patients with prostate cancer (see Appendix 6) and malignant pleural mesothelioma (see Appendix 7)
•6.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/?L
•-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 exception:
•Patients with known Gilbert disease who have serum bilirubin level ? 3 × ULN may be enrolled
•-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
•-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-therapy-induced amenorrhea) or surgically sterile must have a negative se

排除标准

•1.Hematologic malignancies, NSCLC, triple-negative breast cancer, urothelial bladder cancer, renal cell carcinoma, melanoma, and glioblastoma
•2.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 treated with expected curative
•3.Uncontrolled tumor-related pain
•4.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
•5.Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
•6.Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
•7.Leptomeningeal disease
•8.Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ? 2 weeks prior to Cycle 1, Day 1
•9.Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed: hormone-replacement therapy or oral contraceptives and palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day. 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.Significant cardiovascular disease, such as New York Heart Association cardiac disease, myocardial infarction within 3 months prior to Cycle 1, Day 1, unstable arrhythmias or unstable angina
•13.Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia
•14.Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day. Patients receiving prophylactic antibiotics are eligible
•15.Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
•16.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
•17.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the MPDL3280A formulation
•18.History of autoimmune disease. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
•Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
•19.Prior allogeneic bone marrow transplantation or prior solid organ transplantation
•20.History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field is permitted
•21.Any other diseases, metabolic dysfunction, physical examination

研究者

发起方

Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.

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