EUCTR2019-003375-19-GB进行中（未招募）1 期
A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 999
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. Participant must be =18 years of age, at the time of signing the informed consent (except in Japan, where participants must be =20 years).
- •Type of Participant and Disease Characteristics
- •2. Histological confirmed diagnosis of high-risk, non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology) defined as any of the following per World Health Organization grading system.
- •a. T1 tumor;
- •b. High-grade Ta tumor;
- •c. Carcinoma in situ (CIS);
- •3. Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent TURBT occurring within 12 weeks prior to randomization. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association,
- •European Association of Urology.
- •4. Availability of the tumor tissue from the most recent TURBT for the assessment of the PD-L1 expression. If a second TURBT was performed, as indicated according to the current locally applicable guidelines, the tumor tissue from the TURBT procedure that supports the primary diagnosis for study eligibility should be the tumor tissue used for the PD-L1 expression testing.
- •5. ECOG Performance Status (PS) = 2.
- •6. Adequate Bone Marrow Function (without hematopoietic growth factor or transfusion support within 14 days prior to study randomization), including:
- •a. Absolute neutrophil count (ANC) =1,500/mm3 or =1.5 x 109/L;
- •b. Platelets =100,000/mm3 or 100 x 109/L;
- •c. Hemoglobin =9 g/dL (=5.6 mmol/L).
- •7. Adequate renal function defined by an estimated creatinine clearance =30 mL/min according to the Cockcroft Gault formula or by 24-hour urine collection for creatinine clearance, or according to local institutional standard method.
- •8. Adequate liver function, including:
- •a. Total serum bilirubin =1.5 × the upper limit of normal range (ULN).
- •Participants with Gilbert syndrome who should have total serum bilirubin <3 x ULN;
- •b. Aspartate and alanine aminotransferase (AST and ALT) = 2.5 × ULN.
- •9. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
- •10. Male or Female
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Male Participants: Male participants are eligible to participate if they agree to the following during the
- •intervention period and for at least 6 months after the last dose of study treatment:
- •? Refrain from donating sperm
- •PLUS either:
- •? Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •? Must agree to use contraception/barrier as detailed below
- •? Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- •Female Participants:
- •A female participant is eligible to participate if she is not pregnant or breast-feeding, and at least one of the following conditions applies:
- •? Is not a woman of childbearing potential; (WOCBP) refer to Appendix 10.4 for definition.
- •? Is a WOCBP and using a contraceptive meth
排除标准
- •Medical Conditions
- •1. Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium.
- •2. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Participants with diabetes type I, vitiligo, psoriasis, or hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- •3. Severe active infections including pulmonary tuberculosis requiring systemic therapeutic oral or IV antibiotics within 2 weeks prior to randomization. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection) are eligible.
- •4. Other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance without any plans for treatment intervention (eg, surgery, radiation, or castration) or other concurrent malignancy investigator feels has a very low likelihood to become metastatic.
- •5. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis.
- •6. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -eg, presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody test result at screening or within 3 months prior to randomization) is acceptable if the participant otherwise meets entry criteria.
- •Prior/Concomitant Therapy
- •7. Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed.
- •8. Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic Tlymphocyte-
- •associated antigen-4 (CTLA-4) antibody.
- •9. Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15, interferon (INF)-gamma.
- •10. Prior radiation therapy to the bladder.
- •11. Treatment with systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
- •12. Vaccination with live attenuated vaccines within 4 weeks prior to randomization is prohibited; however, inactivated vaccines are permitted.
- •13. Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •Prior/Concurrent Clinical Study Experience
- •14. Participation in other studies involving investigational drug(s) within 4 weeks prior to randomization.
- •Diagnostic assessments
- •15. Known or documented absolute and/or relative contraindication of adjuvant intravesical BCG treatment:
- •a. Prior BCG sepsis or systemic infection (including current urinary tract infection)
- •b. Total bladder incontinence defined as use more than 6 pads in 24 hours
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