EUCTR2018-002100-13-GR进行中（未招募）1 期
Intravesical administration of Durvalumab (MEDI4736) to patients with high-risk, non-muscle-invasive bladder cancer (NMIBC). A phase II study with correlative biomarker studies.
Hellenic GenitoUrinaty Cancer Group (HGUCG)0 个研究点目标入组 39 人开始时间: 2018年9月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
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 and any locally-required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •2. Age > 18 years at time of study entry
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4. Body weight >30kg
- •5. Diagnosis of high grade, non-muscle invasive urothelial carcinoma. High-grade carcinoma includes the following types
- •6. Failure in previous intravesical treatment with Bacillus Calmette Guerin (BCG). Failure in BCG defined as:
- •6a. Disease refractory to Bacillus Calmette Guerin (BCG) therapy to adequate BCG exposure. BCG refractory disease is defined as
- •If high-grade tumor appears during BCG therapy
- •If high-grade, non-muscle-invasive papillary tumor is present at three months
- •If CIS (without concomitant papillary tumor) is present at three and six months
- •Adequate exposure is defined as a minimum of 5 out of 6 BCG induction doses. Maintenance or re-induction can be used according to local practice but are not mandatory for the definition of adequate exposure.
- •6b High grade recurrence after an initial response to BCG therapy.
- •6c. Patients intolerant to adequate BCG exposure, defined as:
- •fewer than 5 instillations of BCG induction therapy
- •No more than one cycle of maintenance BCG therapy
- •7. Subjects may have received other intravesical or systemic therapies for NMIBC or CIS before or after receiving BCG, as long as they meet the aforementioned criteria for BCG refractory disease.
- •8. Subjects are not candidates for immediate cystectomy or have elected not to undergo the procedure.
- •9. Adequate normal organ and marrow function as defined below:
- •a) Haemoglobin = 9.0 g/dL
- •b) Absolute neutrophil count (ANC) > 1500 per mm3
- •c) Platelet count >100,000 per mm3
- •d) Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- •e) AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be = 5x ULN
- •f) Serum creatinine Cl>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
- •10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •a) Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •b) Women =50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or u
排除标准
- •1. Disease of the upper urinary tract or prostatic urethra
- •2. ECG with QTcF value >470 ms
- •3 Participation in another clinical study with an investigational product during the last 4 weeks
- •4. 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
- •5. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) within 14 days prior to the first dose of study drug. Immediate postoperative intravesical instillation of epirubicin or mitomycin C is allowed if occurred more than 14 days prior to the first dose of the study drug.
- •6. 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 Subjects with Grade =2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
- •7. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
- •8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- •9. History of allogenic organ transplantation.
- •10. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, 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]) - more details in protocol.
- •11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- •12. History of another primary malignancy with exceptions described in protocol
- •13. History of leptomeningeal carcinomatosis
- •14. History of active primary immunodeficiency
- •15. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. Subjects with a past or resolved HBV infection are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA (see details in protocol)
- •16. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab with exceptions described in protocol
- •17. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Subjects, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- •18. Female subjects who are pregnant
研究者
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