A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder who are not Receiving Radical Cystectomy - SunRISe-2

Janssen-Cilag International NV0 个研究点目标入组 550 人开始时间: 2021年1月13日最近更新: 2024年3月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Janssen-Cilag International NV
入组人数: 550

研究概览入排标准研究者记录与标识符相似试验

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. =18 years (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent
•2. Histologically proven, cT2-T4a N0, M0 urothelial carcinoma of the bladder. Initial diagnosis must have been within 120 days of randomization date. Participants with variant histologic subtypes (e.g. squamous cell carcinoma) are allowed if urothelial (transitional cell) differentiation is predominant. However, the presence of small cell or neuroendocrine variants will make a participant ineligible.
•3. Ineligible for or have elected not to undergo radical cystectomy.
•4. All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to CTCAE version 5.0 Grade = 2 prior to randomization
•5. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
•6. Thyroid function tests are within the normal range per investigator assessment (or stable on hormone supplementation). Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal test results.
•7. Adequate bone marrow, liver, and renal function:
•a. Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding 2 weeks):
•i. Absolute neutrophil count (ANC) = 1,500/mm^3
•ii. Platelet count =80,000/mm^3
•iii. Hemoglobin =9.0 g/dL
•b. Liver function:
•i. Total bilirubin =1.5 x ULN OR direct bilirubin =ULN for participants
•with total bilirubin levels >1.5xULN (except participants with Gilbert’s Syndrome, who must have a total bilirubin < 3.0 mg/dL),
•ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5x institutional ULN
•c. Renal function:
•- Creatinine clearance =30 mL/min using the Cockcroft-Gault formula. 24-hour creatinine clearance test will also be accepted for estimating renal function in situations where Cockcroft-Gault formula is not a good predictor of estimating adequate renal function.
•Note: If cisplatin is chosen as the radio-sensitizing agent, creatinine clearance must be =50 mL/min.
•8. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies.
•Investigators will advise both male and female participants on the options for banking of sperm and ova, respectively for reproductive conservation.
•a. A participant must be either of the following:
•i. Not of childbearing potential
•ii. Of childbearing potential and practicing true abstinence, or have a sole partner who is vasectomized, or practicing at least 1 highly effective user independent method of contraception
•Participant must agree to continue the above throughout the study and for 6 months after the last dose of study treatment.
•Note: If participant becomes of childbearing potential after start of the study, the woman must comply with point (ii), as described above.
•A participant must also agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study drug, and not be breastfeeding and not planning to become pregnant during the study and for at least 6 months after the last dose of study drug.
•b. Participant must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 6 months after receivi

排除标准

•1. Active malignancies other than the disease being treated under study.
•2. Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder.
•3. Must not have diffuse carcinoma in situ based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder
•at the time of the Screening re-TURBT.
•4. Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging within 42 days prior to randomization.
•5. Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR-200.
•6. Evidence of bladder perforation during diagnostic cystoscopy.
•Participant is eligible if perforation has healed prior to randomization.
•7. Bladder post-void residual volume >350 mL at screening after second voided urine.
•8. History of clinically significant polyuria with recorded 24-hour urine volumes greater than 4,000-mL.
•9. Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to randomization.
•10. Received intervening serial intravesical chemotherapy or
•immunotherapy from the time of pre-screening (diagnostic) or screening (completion) cystoscopy/Transurethral Resection of Bladder Tumor to starting study treatment. Peri-operative intravesical chemotherapy prior to study treatment is allowed per institutional guidelines.
•11. Prior therapy with an anti-programmed cell death 1, anti-PD-ligand 2 agent, or with an agent directed to another co-inhibitory T-cell receptor.
•12. Participants with a history of Grade =3 toxic effects when using anti-TNF or anti-IL-6 agents.
•13. Received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment or not recovered from adverse events due to a previously administered agent. Participants with a history of prior pelvic
•radiotherapy are excluded
•14. An active autoimmune disease that has required systemic treatment in the past 2 years are excluded.
•15. Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (eg, COVID 19) by local health authorities are allowed.
•16. Active infection requiring systemic therapy within 14 days prior to randomization.
•17. Has had an allogeneic tissue/solid organ transplant.
•18. A pyeloureteral tube externalized to the skin is exclusionary. Unilateral nephrostomy tube or ureteral stent is permitted if it does not interfere with placement or retention of TAR-200 in the bladder. Participants with unilateral hydronephrosis are permitted; however, participants with bilateral hydronephrosis are excluded.
•19. Indwelling urinary catheters are not permitted; however, intermittent catheterization is acceptable.
•20. Participants who require immunosuppressive medications including but not limited to systemic corticosteroid at doses >10 mg/day of prednisone or its equivalence, methotrexate, cyclosporine, azathioprine, and TNF-alpha blockers. Use of immunosuppressive medications for the management of immune related adverse events, infusion related reactions, or in participants with contrast allergies is acceptable. Use of inhaled, topical, and intranasal corticosteroids are permitted

研究者

发起方

Janssen-Cilag International NV

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