CTRI/2019/07/020184进行中（未招募）3 期
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination with Standard of Care Chemotherapy and Durvalumab in Combination with Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients with Unresectable Locally Advanced or Metastatic Urothelial Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Informed consent
- •1.Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •2.Provision of signed and dated, written ICF prior to any mandatory study-specific procedures, sampling, and analyses
- •3.Age greater or equal to 18 years at the time of screening.
- •Type of patient and disease characteristics
- •4. Individuals with histologically or cytologically documented transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra), unresectable, locally advanced, or metastatic (ie, T4b, any N; or any T, N2-N3, or M1; based on clinical TNM [tumor/node/metastasis] staging) (who have not been previously treated with first-line chemotherapy.(Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred greater than 12 months from the last therapy [for chemoradiation and adjuvant treatment] or Greater than 12 months from the last surgery [for neoadjuvant treatment]
- •5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment
- •6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization.
- •7.Tumor PD-L1 status, with immunohistochemistry (IHC) assay confirmed by a reference laboratory, must be known prior to randomization. As such, all patients must be able to provide a newly acquired tumor biopsy ( <3 months) during screening (preferred) or provide an available tumor sample taken =3 years prior to screening.
- •Tumor lesions used for newly acquired biopsies should not be target lesions, unless there are no other lesions suitable for biopsy, and in this instance, only core needle (not excisional/incisional) biopsy is allowed. For patients with a single target lesion, if screening biopsy is collected prior to screening imaging for baseline tumor assessment, allow at least approximately 2 weeks before imaging scans are acquired.
- •Samples with limited tumor content and fine-needle aspirate specimens are not acceptable. Specimens from metastatic bone lesions are typically unacceptable unless there is a significant soft-tissue component. The tumor specimen submitted to establish eligibility should be of sufficient quantity to allow for PD-L1 IHC and exploratory biomarker analyses, as appropriate and is preferred in formalin-fixed paraffin-embedded blocks.
- •8. Patients eligible or ineligible for cisplatin-based chemotherapy, Cisplatin ineligibility is defined as meeting one of the following criteria:
- •a)Creatinine clearance less than 60 mL/min and greater than 30 mL/min calculated by Cockcroft-Gault equation or by measured 24-hour urine collection.(In cases where both are performed, measured 24-hour urine collection will be used to determine eligibility, providing an adequate collection was performed.)
- •b) Common Terminology Criteria for Adverse Events (CTCAE) Grade greater or equal to 2 audiometric hearing loss
排除标准
- •1. History of allogeneic organ transplantation.
- •2. 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]).
- •The following are exceptions to this criterion:
- •a)Patients with vitiligo or alopecia
- •b)Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
- •c)Patients with any chronic skin condition that does not require systemic therapy
- •d)Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- •e)Patients with celiac disease controlled by diet alone
- •3. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhoea, 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
- •4. History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease =5 years before the first dose of IP and of low potential risk for recurrence
- •a) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •b) Adequately treated carcinoma in situ without evidence of disease
- •5. History of leptomeningeal carcinomatosis
- •6. History of active primary immunodeficiency
- •7. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV ½ antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg, DNA negative) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- •8. 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
- •a) Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician.
- •b) Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab or SoC chemotherapy may be included only after consultation with the study physician.
- •9. Untreated central nervous system metastases and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to signing the ICF. Patients with a history of brain metastases or with suspected brain metastases at screening must have an MRI (preferred) or CT each preferably with IV contrast of
研究者
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