NCT05495724招募中2 期
An Open Label, Phase 2 Study of Disitamab Vedotin Combined With Tislelizumab for Patients With Her2 Overexpressing (IHC2+ or 3+) High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
Tianjin Medical University Second Hospital1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2021年7月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Complete Response (CR) Rate
研究概览
简要总结
This is a phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with Disitamab Vedotin in combination with tislelizumab every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Urothelial carcinoma with Her2 IHC 2+ or 3+;
- •High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component > 50%, difined as following:
- •a. T1 b. High-grade Ta c.Carcinoma in situ(CIS);
- •Multi-point biopsy of bladder shows there are more than 2 section and over 3 points of pathological specimens are diagnosed as above, meanwhile, the tumor has to be diagnosed as not completely resectable by at least 2 senior urologist;
- •Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)
- •Organ function level must meet or under the support treatment meet the following requirements:
- •Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 9.0 g/dl;
- •Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=2.5 ULN（patient with metastatic liver cancer：aminotransferase <=5.0 ULN）;
- •Renal function: creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 50 ml/min;
- •The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;
排除标准
- •Active, known or suspected autoimmune diseases;
- •History of primary immunodeficiency;
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- •Pregnant or lactating female patients;
- •Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
- •Prior use of immunosuppressive drugs within 4 weeks prior to the start of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose);
- •Known or suspected allergy to disitamab vedotin or tislelizumab;
- •Have a clear history of active tuberculosis;
- •Participating in other clinical researchers;
- •Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
- •Uncontrolled concurrent diseases, including but not limited to:
- •HIV infected (HIV antibody positive);
- •Severe infection in active stage or poorly controlled;
- •Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]);
- •Patients with active bleeding or new thrombotic disease
研究组 & 干预措施
Disitamab Vedotin and Tislelizumab
Experimental
Disitamab Vedotin 120mg IV on day 1 in combination with Tislelizumab 200mg IV on day 2 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.
干预措施: Disitamab Vedotin Tislelizumab (Drug)
Disitamab Vedotin
Other
Disitamab Vedotin 120mg IV on day 1 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.
干预措施: Disitamab Vedotin (Drug)
结局指标
主要结局
Complete Response (CR) Rate
时间窗: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of disitamab vedotin)
次要结局
- Cystectomy-Free Survival (CFS)(up to 3 years)
- Duration of Response (DOR)(up to 3 years)
- Recurrence Free Survival（RFS）(up to 3 years)
- PD-1 expression status(up to 3 years)
- Progress Free Survival（PFS）(up to 3 years)
- Event-Free Survival（EFS）(up to 3 years)
- Number of adverse events and severity by grade (CTCAE)(12 weeks of treatment plus 30 days for toxicity followup)
- Her2 status(up to 3 years)
研究者
研究点 (1)
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