EUCTR2020-004223-16-ES进行中（未招募）1 期
A phase II study investigating preoperative bintrafusp alfa in operable urothelial carcinoma of the bladder.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
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 urothelial carcinoma (T2-T4aN0-1M0) of the bladder where radical cystectomy with bilateral pelvic lymph node dissection is indicated. Patients with variant histology” such as micropapillary, plasmocytoid, nested, sarcomatoid, microcystic, squamous and adeno variants of urothelial carcinoma are required to have more than 50% of tumor tissue with transitional cell pattern.
- •5. Residual disease after TURBT or endoscopy (surgical opinion, cystoscopy or radiological presence).
- •6. Fit and planned for surgery (according to local guidelines).
- •7. N0-1 and M0 disease CT or MRI (within 4 weeks of enrolment). Patients with N2 disease on cross sectional imaging are excluded from the study.
- •8. Representative formalin-fixed paraffin embedded (FFPE) tumour samples with an associated pathology report that are determined to be available and sufficient for central testing.
- •9. Patients who will not receive neoadjuvant cisplatin based chemotherapy, refuse neoadjuvant cisplatin-based chemotherapy or in whom neoadjuvant cisplatin-based therapy is not appropriate.
- •10.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •11.Negative serum pregnancy test within 14 days of Day 1 Cycle 1 for female patients of childbearing potential.
- •12.Highly effective method of contraception throughout the study until 2 months after the last dose of bintrafusp alfa for female patients of childbearing potential and 4 months after the last dose of bintrafusp alfa for male patients. Refer to section 6.11.1.1 for further details.
- •13.Adequate haematologic and end-organ function within 4 weeks prior to the first study treatment defined by the following:
- •a. ANC = 1500 cells/µL (without granulocyte colony-stimulating factor support within 14 days prior to Cycle 1, Day 1)
- •b. WBC counts > 2500/µL
- •c. Lymphocyte count = 500/µL
- •d. Platelet count = 100,000/µL (without transfusion within 14 days prior to Cycle 1, Day 1)
- •e. Haemoglobin = 9.0 g/dL (patients may be transfused or receive erythropoietic treatment to meet this criterion).
- •f. AST or ALT, and alkaline phosphatase = 1.5 times the institutional upper limit of normal (ULN) and serum bilirubin = 1.5 times the institutional ULN (patients with known Gilbert disease who have serum bilirubin level = 3 × the institutional ULN may be enrolled).
- •g. INR and aPTT = 1.5 × the institutional ULN. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- •h. 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 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Pregnant and lactating female patients.
- •2. 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.
- •3. Previous intravenous chemotherapy or immune therapy for bladder cancer.
- •4. Patients with prior allogeneic stem cell or solid organ transplantation.
- •5. Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
- •6. Has received any prior radiotherapy to the bladder.
- •7. Patients must not have had oral or intravenous (IV) steroids for 14 days prior to Cycle 1 Day 1.
- •8. Received therapeutic IV antibiotics within 14 days prior to enrolment.
- •9. 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.
- •10. 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.
- •11. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrolment.
- •12. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results.
- •13. Malignancies other than urothelial carcinoma of the bladder within 3 years prior to enrolment
- •14. Severe infections within 4 weeks prior to enrolment.
- •15. Significant cardiovascular disease.
- •16. History of idiopathic pulmonary fibrosis.
- •17. Patients with uncontrolled Type 1 diabetes mellitus.
- •18. Patients with active hepatitis infection.
- •19. Positive test for HIV.
- •20. Patients with active tuberculosis.
- •21. History of autoimmune disease.
- •22. History of bleeding diathesis or recent major bleeding events.
- •23. Has a diagnosis of immunodeficiency.
- •24. Receiving chronic systemic steroid therapy.
- •25. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- •26. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the bintrafusp alfa formulation.
- •27. Serious non-healing wound/ulcer/bone fracture.
研究者
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