EUCTR2016-002522-36-DE进行中（未招募）1 期
An open label phase II study to evaluate the efficacy and safety of PDR001in patients with advanced or metastatic, well-differentiated, non-functionalneuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracicorigin or poorly-differentiated gastroenteropancreatic neuroendocrinecarcinoma (GEP-NEC), that have progressed on prior treatment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
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. Written informed consent must be obtained prior to any screening
- •2. Adult males or females = 18 years at screening.
- •3. Pathologically confirmed, advanced (unresectable or metastatic):
- •? Well-differentiated (G1 or G2) based on local pathology report, , nonfunctional
- •neuroendocrine tumor of GI, pancreatic or thoracic (including lung and
- •? Poorly-differentiated GEP-NEC based on local pathology report
- •4. No active symptoms related to carcinoid syndrome during the last 3
- •months prior to start
- •of study treatment.
- •5. Patients must have received prior treatment for advanced disease:
- •? Well-differentiated NET group:
- •a. Thoracic (lung and thymus origin) cohort:
- •? Thymus origin: at least one prior systemic therapy according to
- •investigator's
- •? Lung origin: at least one prior systemic therapy is required, which
- •must include
- •everolimus.
- •b. GI cohort: at least two prior systemic regimens, which must include
- •everolimus. Prior
- •systemic therapies may include: somatostatin analogs, PRRT, and/or
- •chemotherapy.
- •c. pNET cohort: at least two prior systemic regimens, which must include
- •and/or sunitinib. Prior systemic therapies may include: somatostatin
- •analogs, PRRT
- •and/or chemotherapy.
- •Note: For well-differentiated NET, Prior treatment with interferon alpha
- •provided that it is not the last treatment received prior to study entry.
- •? Poorly-differentiated GEP-NEC group: at least one prior chemotherapy
- •according to Investigator's choice.
- •6. Radiological documentation of disease progression:
- •? Well-differentiated NET group: Disease progression while on/or after
- •treatment, and this progression must have been observed within 6
- •months prior to
- •start of study treatment (i.e. maximum of 24 weeks from documentation
- •progression until study entry). Disease must show evidence of
- •radiological disease
- •progression based on scans performed not more than 12 months apart.
- •? Poorly-differentiated GEP-NEC group: Disease progression while on or
- •after prior
- •7. At least one measurable lesion assessed by CT and/or MRI according
- •to RECIST 1.1.
- •Note: Any lesions which have been subjected to percutaneous therapies
- •or radiotherapy
- •should not be considered measurable, unless the lesion has clearly
- •progressed since the
- •8. Patient must have an Eastern Cooperative Oncology Group (ECOG)
- •performance status 0-
- •9. Tumor biopsy material must be provided for all patients for the purpose of biomarker
- •? Well-differentiated (G1/2) NET: Biopsy material must be provided
- •following the
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排除标准
- •1. Well-differentiated, grade 3 neuroendocrine tumors; poorlydifferentiated
- •neuroendocrine carcinoma of any origin (other than GEPNEC);
- •including NEC of unknown origin, adenocarcinoid, and goblet cell
- •2. Pretreatment with interferon as last treatment prior to start of study
- •3. Prior treatment for study indication
- •4. Systemic chronic steroid therapy (= 10mg/day prednisone or
- •equivalent) or any
- •immunosuppressive therapy 7 days prior to planned date for first dose of
- •study treatment.
- •5. Any untreated central nervous system (CNS) lesion.
- •7. Malignant disease, other than that being treated in this study.
- •8. Major surgery, open biopsy, or significant traumatic injury within 2
- •weeks prior to start of study treatment.
- •9. Anticipation of the need for major surgical procedure during the
- •course of the study
- •10. Radiation therapy within 4 weeks prior to start of study treatment
- •12. History of severe hypersensitivity reactions to other monoclonal
- •antibodies .
- •13. Impaired cardiac function or clinically significant cardiac disease,
- •14. Autoimmune disease that has required systemic treatment. Stable
- •and adequate controlled endocrinopathies requiring replacement therapy
- •are not considered as systemic treatment and therefore are allowed.
- •15. Active infection requiring systemic antibiotic therapy.
- •16. Known history of testing positive for Human Immunodeficiency Virus
- •(HIV) infection.
- •17. Patients with active Hepatitis B infection (HBsAg positive) will be
- •18. Patients with positive test for hepatitis C ribonucleic acid (HCV RNA).
- •19. Any medical condition that would, in the investigator's judgment,
- •prevent the patient's participation in the clinical study due to safety
- •concerns, compliance with clinical study procedures or interpretation of
- •study results.
- •20. Use of any live vaccines against infectious diseases within 4 weeks of
- •initiation of study treatment.
- •21. Presence of = CTCAE grade 2 toxicity (except alopecia, peripheral
- •neuropathy, and
- •ototoxicity, which are exclusion criteria if = CTCAE grade 3) due to prior
- •cancer therapy.
- •22. Not able to understand and to comply with study instructions and
- •requirements.
- •23. Pregnant or nursing (lactating) women confirmed by a positive hCG
- •laboratory test within 72 hours prior to initiating study treatment. Note:
- •Low levels of hCG may also be considered a tumor marker, therefore if
- •low hCG levels are detected, another blood sample at least 4 days later
- •must be taken to assess the kinetics of the increase and transvaginal
- •ultrasound must be performed to rule out pregnancy.
- •24. Women of child-bearing potential, defined as all women
- •physiologically capable of becoming pregnant, unless they are using
- •highly effective methods of contraception during dosing and for 150 days
- •after stopping treatment with PDR001. Highly effective
- •contraception methods include:
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研究者
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