EUCTR2015-002055-10-AT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.
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
- 176
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-T3b 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) no
- •F.1.2.1 Number of subjects for this age range 51
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
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 (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome).
- •? Pregnant female patients. All female patients of childbearing potential with a positive pregnancy test within 2 weeks prior to the first dose of study treatment will be excluded from the study. A WOCBP should agree to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- •? Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias, or unstable angina.
- •? Has a history or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval >480 msec is excluded (corrected by Fridericia formula or Bazett formula). In the event that a single QTc is >480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is <480 milliseconds. ? Severe infections within 4 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
- •? Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.
- •? Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to randomization (Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible).
- •? History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins ? Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the pembrolizumab formulation
- •History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- •? Patients with a histor
研究者
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