ISRCTN15842444进行中（未招募）1 期
INVEST: Phase I study of Intravesical immunotherapy for bladder cancer patients undergoing radical cystectomy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
- 性别
- All
入选标准
- •1. Patient must be fully informed about the study and have signed the informed consent form
- •2. Patients with mixed histologies are required to have predominant urothelial cell carcinoma in the bladder
- •3. Patients with pTis to T4N0 M0 for whom radical cystectomy is planned treatment for their urothelial cell carcinoma of the bladder. Radical cystectomy must be scheduled at least 6 weeks after confirmation of eligibility. This will include both MIBC and high-grade NMIBC tumours.
- •4. Patients with MIBC must be ineligible for cisplatin-based neo-adjuvant chemotherapy or have declined neoadjuvant chemotherapy
- •5. Aged 18 years old and over
- •6. Performance status: Eastern Co-operative Oncology Group (ECOG) 0-2
- •7. Patient must be willing and able to comply with the protocol, have mental capacity and (if a woman of childbearing potential [WOCBP]) use effective contraception throughout treatment and for 5 months after treatment completion
- •8. Have diagnostic biopsy tissue material (i.e., transurethral resection of bladder tumour [TURBT] sample) available for use in the trial
- •9. Adequate organ function within 28 days prior to confirmation of eligibility and 7 days of study treatment as defined below:
- •9.1. White blood cell count (WBC): >2X10^9/L
- •9.2. Lymphocyte count: = 0.5 x 10^9/L (= 500/µL)
- •9.3. Neutrophils: =1.5 X10^9/L
- •9.4. Platelets: =100 X10^9/L
- •9.5. Estimated glomerular filtration rate (eGFR): >30mL/min
- •9.6.Serum total bilirubin: <1.5 x upper limit of normal (ULN) OR =3 ULN in a patient with Gilbert’s Syndrome AND direct bilirubin =ULN
- •9.7.Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT): =1.5 x ULN
- •9.8.Haemoglobin: =90g/L
- •9.9.Urine dipstick: Negative for nitrites. (If positive then a negative MSU is required. If positive MSU then infection must be treated prior to starting treatment.)
排除标准
- •1. Active urinary tract infection in last 2 weeks prior to assessing eligibility.
- •2. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteraemia, or severe pneumonia, or any active infection that could impact patient safety.
- •3. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease (COPD) exacerbation) are eligible for the study.
- •4. Presence of indwelling urinary stent or history of vesico-ureteric reflux.
- •5. Other intravesical therapy within 2 weeks of assessing eligibility.
- •6. Prior radiotherapy to bladder or planned radiotherapy to bladder.
- •7. Reduced bladder capacity (defined as an inability to hold an intravesical instillation for 1 hour).
- •8. Positive pregnancy test (as eligibility assessment for WOCBP), breast-feeding women, patients intending to become pregnant during and within 5 months after last dose of atezolizumab, or patients unwilling to comply with contraception requirements.
- •9. Patients with active, known, or suspected autoimmune disease with the following exceptions:
- •9.1. Patients with vitiligo or alopecia;
- •9.2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement;
- •9.3. Any chronic skin condition that does not require systemic therapy;
- •9.4. Patients with coeliac disease controlled by diet alone;
- •9.5. Patients with Crohn’s disease or ulcerative colitis (must be inactive stable disease).
- •10. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor-a [TNF-a] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
- •10.1. Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
- •10.2. Patients who received mineralocorticoids (e.g., fludrocortisone), inhaled or low dose corticosteroids for COPD or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
- •11. Positive test for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- •12. Patients considered a poor medical risk by the investigator due to a serious, uncontrolled medical disorder, non-malignant system disease or active uncontrolled infection. Examples include but are not limited to; active COVID-19 infection, any psychiatric disorder that prohibits obtaining informed consent or protocol compliance.
- •13. Prior systemic immune checkpoint inhibitor therapy (prior BCG is permitted).
- •14. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
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