EUCTR2015-002055-10-IT进行中（未招募）1 期
PURE-01 An open label, single-arm, phase 2 study of neoadjuvant pembrolizumab (MK-3475) before cystectomy for patients with muscle-invasive urothelial bladder cancer. - PURE-01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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.Willing and able to provide written informed consent.
- •2.Ability to comply with the protocol.
- •3.Age = 18 years.
- •4.Histopathologically confirmed transitional cell carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.
- •5.Fit and planned for cystectomy (according to local guidelines).
- •6.Clinical stage T2-T4a N0 M0 disease by CT (or MRI) + PET/CT (within 4 weeks of randomization by RECIST v1.1).
- •7.Residual disease after TURB (surgical opinion, cystoscopy or radiological presence).
- •8.Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for testing at the study sponsor site and determined to be evaluable for tumor PD-L1 expression prior to study enrolment; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Merck representatives.
- •9.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- •10.Adequate hematologic and end-organ function defined by the following laboratory results obtained within 28 days prior to the first study treatment:
- •11.Absolute Neutrophil Count = 1,500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1).
- •12.Lymphocyte count = 500/µL.
- •13.Platelet count = 100,000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1).
- •14.Haemoglobin = 9.0 g/dL - Patients may be transfused or receive erythropoietic treatment to meet this criterion.
- •15.AST, ALT, and alkaline phosphatase = 2.5 times the upper limit of normal (ULN), with the following exceptions:
- •a.Patients with known Gilbert disease who have serum bilirubin level = 3 × ULN may be enrolled.
- •16.INR and aPTT = 1.5 × ULN. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- •17.Calculated creatinine clearance = 30 mL/min (Cockcroft-Gault formula).
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Patients taking regular oral steroids, above the allowed limit of 10mg/day methylprednisolone or analogues, for any reason. Patients must not have had steroids for 28 days prior to study entry.
- •Previously intravenous chemotherapy bladder cancer. Patients who have previously had radiotherapy or concurrent chemo-radiation would be eligible.
- •Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score = 3 + 4 and PSA < 10 ng/mL undergoing active surveillance and treatment naive).
- •Evidence of measurable nodal or metastatic disease.
- •Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
- •Pregnant female patients
- •Significant cardiovascular disease
- •Severe infections within 4 weeks prior to enrolment in the study
- •Major surgical procedure within 4 weeks prior to enrolment
- •Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to randomization
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •History of autoimmune disease
- •Patients with a history of autoimmune-related hypothyroidism, unless on a stable dose of thyroid-replacement hormone.
- •Patients with uncontrolled Type 1 diabetes mellitus
- •Uncontrolled hypercalcemia
- •Patients with prior allogeneic stem cell or solid organ transplantation.
- •History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
- •Positive test for HIV.
- •Patients with active hepatitis infection
- •Patients with active tuberculosis.
- •Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
- •Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study
- •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrolment
- •History of severe immune-related adverse effects from anti-CTLA-4 (CTCAE Grade 3 and 4).
- •Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment.
研究者
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