EUCTR2019-003375-19-IT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, BCGNaïve Non-Muscle Invasive Bladder Cancer -
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:
- •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.
- •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.
- •For full list of Inclusion Criteria please refer to Study Protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 299
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 700
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 Tlymphocyteassociated
- •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 within 4 weeks from randomization and while on study treatment is prohibited except for administration of inactivated vaccines.
- •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.
- •For full List of Exclusion Criteria please refer to Study Protocol.
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