EUCTR2019-003375-19-BE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 andMaintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC
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
- 1,159
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
- •All Cohorts
- •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 positive TURBT occurring within 12 weeks prior to randomization for participants in Cohort A, or within 12 weeks prior to initiation of study intervention for participants in Cohorts B1 and B2. 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 for participants in Cohort A, or within 14 days prior to initiation of study intervention for participants in Cohorts B1 and B2 ), 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
- •Informed Consent
- •11. Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol
- •Cohorts B1 and B2 only
- •12. Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium of the urinary bladder defined as any of the following:
- •a) Cohort B1: persistent or recurrent CIS alone or with concomitant recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy. Stage and grade must be confirmed by the BICR prior to registration;
- •b) Cohort B2: recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy;
- •c) Cohort B2: T1 high-grade disease at th
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. For Cohort B1, absence of muscle-invasive and extravesical disease must be confirmed by the BICR prior to registration.
- •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 for participants in Cohort A, or within 2 weeks prior to initiation of study intervention for participants in Cohorts B1 and B2. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection) are eligible.
- •4.Other malignancy within 5 years prior to randomization for participants in Cohort A, or within 5 years prior to initiation of study intervention for participants in Cohorts B1 and B2, 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 the investigator feels has a very low likelihood to become metastatic after discussion with the sponsor.
- •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 for participants in Cohort A, or within 3 months prior to initiation of
- •study intervention for participants in Cohorts B1 and B2) is acceptable if the participant otherwise meets entry criteria.
- •Prior/Concomitant Therapy
- •7.Cohort A: Intravesical BCG therapy within 2 years prior to randomization. Cohorts B1 and B2: Any systemic or intravesical chemotherapy or immunotherapy from the time of most recent positive TURBT to initiation of study intervention (single-dose intravesical chemotherapy as part of the most recent positive TURBT according to the current locally applicable guidelines is allowed). Prior intravesical chemotherapy for NMIBC is allowed in all Cohorts.
- •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 for participants in Cohort A, or within 4 weeks prior to initiation of study intervent
研究者
相似试验
进行中（未招募）
1 期
CREST - Phase 3 Study of sasanlimab (PF-06801591) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder CancerMedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 100000004864EUCTR2019-003375-19-GBPfizer Inc.999
进行中（未招募）
1 期
Phase 3 Study of PF-06801591 in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-Risk Non-Muscle Invasive Bladder CancerMedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 100000004864EUCTR2019-003375-19-FRPfizer Inc.999
进行中（未招募）
3 期
Sasanlimab (PF-06801591) in Combination With BCG or as Single Agent in Participants With High-Risk Non-Muscle Invasive Bladder Canceron-muscle Invasive Bladder CancerJPRN-jRCT2071200044Kawai Norisuke1,067
进行中（未招募）
1 期
Phase 3 Study of PF-06801591 in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-Risk Non-Muscle Invasive Bladder CancerEUCTR2019-003375-19-ITPFIZER INC999
进行中（未招募）
1 期
CREST - Phase 3 Study of sasanlimab (PF-06801591) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder CancerEUCTR2019-003375-19-PTPfizer Inc.999