NL-OMON49675已完成2 期
A Phase 2, single-arm study of bempegaldesleukin (NKTR-214) in combination with nivolumab in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients - Bladder cancer trial
PPD0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Each patient will be entered into this study only if he/she meets all of the
- •following criteria: • Male or female patients, age 18 years or older at the
- •time of signing the informed consent form (ICF). • Histologically or
- •cytologically documented urothelial cell carcinoma (also termed TCC) including
- •renal pelvis, ureters, urinary bladder, and urethra that is inoperable, locally
- •advanced (T4b, any N; or any T, N2-3) or metastatic (M1, Stage IV).
- •Histologically or cytologically confirmed locally advanced and unresectable or
- •metastatic urothelial cancer, including mixed urothelial cell and
- •non-urothelial cell histologies. If the histology is mixed with non-urothelial
- •carcinoma (e.g., squamous cell carcinoma), the urothelial cell component must
- •be dominant (> 50% of the total histology) • Tumor tissue is required to be
- •analyzed by the central laboratory to document PD-L1 status. • Tissue can be
- •provided in one of two ways:
- •-A new biopsy taken during screening -Archival tissue from either a FFPE tissue
- •block or unstained tumor tissue sections (see Section 7.5). • Archival tissue
- •must be obtained within 12 months prior to enrollment and with no intervening
- •treatment. • An Eastern Cooperative Oncology Group (ECOG) performance status <=
- •2. • Patients must have measurable disease per RECIST 1.1 criteria. • No prior
- •systemic chemotherapy or investigational agent for inoperable locally advanced
- •or mUC. • Patients must be able and willing to comply with the study visit
- •schedule and study procedures.
排除标准
- •A patient will be excluded from this study if he/she meets any of the following
- •1. Female patients who are pregnant or lactating, who plan to get pregnant, or
- •who have a positive serum or urine pregnancy test.
- •2. Active brain metastases or leptomeningeal metastases. Patients with brain
- •metastases are eligible if these have been treated and there is no radiographic
- •evidence of progression for at least 4 weeks after treatment is complete
- •(confirmed by the head imaging obtained within 28 days prior to Cycle 1 Day
- •1). There must also be no requirement for immunosuppressive doses of systemic
- •corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior
- •to Cycle 1 Day 1. Stable dose of anticonvulsants is allowed. Treatment for
- •CNS metastases may include whole brain radiation, stereotactic radiosurgery or
- •neurosurgical resection. Patients with CNS metastases treated by neurosurgical
- •resection or brain biopsy performed within 28 days prior to Cycle 1 Day 1 are
- •not eligible.
- •3. Prior active malignancy within the previous 3 years except for locally
- •curable cancers with negligible risk of metastases or death that have been
- •treated with expected curative outcome, such as basal or squamous cell skin
- •cancer, carcinoma in situ of the prostate, cervix, or breast. An incidental
- •finding of prostate cancer (identified upon resection of the prostate) is
- •acceptable, provided that one of the following criteria is met: T2N0M0, or
- •Gleason score <= 3+4, or prostate-specific antigen (PSA) below upper limit of
- •normal by local laboratory and not requiring active treatment.
- •4. Patients who have an active, known or suspected autoimmune disease.
- •Patients requiring systemic treatment within the past 3 months or a documented
- •history of clinically severe autoimmune disease that requires systemic steroids
- •or immunosuppressive agents.
- •5. Patients with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalent) or other
- •immunosuppressive medications within 14 days of start of Cycle 1 Day 1.
- •6. Patients must not have received prior IL-2 therapy.
- •7. Patients who have received any live / attenuated vaccine within 30 days
- •before Cycle 1 Day 1.
- •8. Prior treatment with an anti PD-1, anti PD-L1, anti-PD-L2, or anti CTLA-4
- •antibody, agents that target IL-2 pathway, or any other antibody or drug
- •specifically targeting T cell costimulation or immune checkpoint pathways
- •9. History of allergy to study drug components.
- •10. History of severe hypersensitivity reaction to any monoclonal antibody.
- •11. History of organ, hematopoetic, or tissue transplant that requires the
- •systemic use of immunosuppressive agents.
- •12. Active infection requiring systemic therapy.
- •13. Any positive test result for hepatitis B virus (HBV) or hepatitis C virus
- •(HCV) indicating presence of virus.
- •14. Known history of positive test for human immunodeficiency virus (HIV) or
- •known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be
- •performed at sites where mandated locally.
- •15. Known cardiovascular history including unstable or deteriorating cardiac
- •disease within the previous 12 months prior to screening including but not
- •limited to the following:a) Unstable angina or myocardial infarction b.
- •Transient ischemic attack/cerebrovascular acci
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