EUCTR2018-003027-11-IT进行中（未招募）1 期
A prospective, multi-center, open-label, single-arm, two- step phase II study of DURvalumab (MEDI4736) in patients WIth poor performance status as first-liNe treatment for advanced urothelial cancer: the DURWIN trial - DURWI
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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. Capable of giving signed informed consent which includes compliance with
- •the requirements and restrictions listed in the informed consent form (ICF) and
- •in this protocol. Written informed consent and any locally required
- •authorization obtained from the patient/legal representative prior to
- •performing any protocol-related procedures, including screening evaluations;
- •2. Patients are eligible for enrolment if they have histologically or cytologically
- •documented locally advanced (on the TNM staging system, T4b and any N; or
- •any T and N2–3) or metastatic (M1, stage IV) urothelial carcinoma (including
- •of the renal pelvis, ureter, urinary bladder, or urethra) who are eligibile to
- •receive first-line systemic treatment and are judged to be ineligible for
- •cisplatin treatment because of ECOG performance status= 2;
- •3. Age > 18 years at time of study entry;
- •4. All patients must have measurable disease defined by Response Evaluation
- •Criteria In Solid Tumors version 1.1 (RECIST v1.1);
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 2;
- •6. Life expectancy of > 12 weeks;
- •7. Body weight >30kg;
- •8. Adequate normal organ and marrow function
- •9. Evidence of post-menopausal status or negative urinary or serum pregnancy
- •test for female pre-menopausal patients. Women will be considered postmenopausal
- •if they have been amenorrheic for 12 months without an
- •alternative medical cause
- •10. Patient is willing and able to comply with the protocol for the duration of the
- •study including undergoing treatment and scheduled visits and examinations
- •including follow up.
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. Participation in another clinical study with an investigational product during
- •the last 28 days,
- •2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study,
- •3. Any prior systemic anticancer therapy received against urothelial carcinoma, with the exception of neoadjuvant or adjuvant chemotherapy if the last dose was administered > 12 months before study inclusion,
- •4. Any previous treatment with a PD-1 or PD-L1 inhibitor, including
- •durvalumab,
- •5. History of another primary malignancy
- •6. Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3
- •electrocardiograms (ECGs) using Fridericia’s Correction,
- •7. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer
- •therapy with the exception of alopecia, vitiligo, and the laboratory values
- •defined in the inclusion criteria,
- •8. Any concurrent chemotherapy, Investigational Product (IP), biologic, or hormonal therapy for cancer treatment.
- •9. Radiotherapy treatment to more than 30% of the bone marrow or with a wide
- •field of radiation within 4 weeks of the first dose of study drug,
- •10. Major surgical procedure (as defined by the Investigator) within 28 days prior
- •to the first dose of IP. Local surgery of isolated lesions for palliative intent is
- •acceptable,
- •11. History of allogenic organ transplantation,
- •12. Active or prior documented autoimmune or inflammatory disorders (including
- •inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis
- •[with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with
- •polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
- •13. Uncontrolled intercurrent illness,
- •14. History of leptomeningeal carcinomatosis,
- •15. Brain metastases or spinal cord compression. Patients with suspected brain
- •metastases at screening should have an MRI (preferred) or CT each preferably
- •with IV contrast of the brain prior to study entry,
- •16. History of active primary immunodeficiency,
- •17. Active infection including tuberculosis (clinical evaluation that includes
- •clinical history, physical examination and radiographic findings, and TB
- •testing in line with local practice), hepatitis B (known positive HBV surface
- •antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus
- •(positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection
- •(defined as the presence of hepatitis B core antibody [anti-HBc] and absence
- •of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are
- •eligible only if polymerase chain reaction is negative for HCV RNA.
- •18. Current or prior use of immunosuppressive medication within 14 days before
- •the first dose of durvalumab.
- •19. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- •Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP
- •and up to 30 days after the last dose of IP,
- •20. Female patients who are pregnant or breastfeeding or male or female patients
- •of reproductive potential who are not willing to employ effective birth control
- •from screening to 90 days after the last dose of durvalumab,
- •21. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients,
- •22. Patients with ECOG performance status of 0-1 -3-4 must be excluded.
- •23. Judgment by the investigator that the patient is unsuitab
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