NL-OMON52608招募中3 期
A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle- Invasive Bladder Cancer - CA017-078
Bristol-Myers Squibb0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
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
- 年龄范围
- 18 至 64（—）
入选标准
- •- Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0,
- •diagnosed at
- •TURBT and confirmed by radiographic imaging. Variant histology is acceptable
- •if there is a
- •predominant urothelial component
- •- Participant must be deemed eligible for RC by his/her urologist and/or
- •oncologist, and must agree
- •to undergo RC after completion of neo-adjuvant therapy
- •- Prior BCG or other intravesical treatment of non-muscle invasive bladder
- •cancer (NMIBC) is
- •permitted if completed at least 6 weeks prior to initiating study treatment
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •- Life expectancy >= 6 months
- •- Documentation of PD-L1 status by immunohistochemistry (IHC) performed by the
- •central lab
- •during the screening period from the TURBT or biopsy that made the diagnosis
- •of MIBC. No
- •systemic therapy (eg, adjuvant or neoadjuvant chemotherapy) should be given
- •after the sample
- •was obtained. PD-L1 results are not required prior to beginning treatment on
- •the safety lead-in.
排除标准
- •- Clinical evidence of positive LN (>= 10 mm in short axis) or metastatic
- •bladder cancer
- •- Prior systemic therapy, radiation therapy, or surgery for bladder cancer
- •other than TURBT or
- •biopsies is also not permitted
- •- Ineligible to receive cisplatin due to Grade 2 or higher peripheral
- •neuropathy or audiometric
- •hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured
- •(24-hour urine) creatinine
- •clearance (CrCl) < 50 mL/min
- •- Participants with an active, known or suspected autoimmune disease.
- •Exceptions per protocol
- •- Participants with conditions known to interfere significantly with the
- •absorption of oral medication,
- •as per investigator judgement
- •- Participants with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily
- •prednisone equivalent) or other immunosuppressive medications within 14 days
- •of randomization.
- •Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg
- •daily prednisone
- •equivalent, are permitted in the absence of active autoimmune disease
- •- Participants with uncontrolled adrenal insufficiency
- •- Participants with a personal or family (i.e., in a first-degree relative)
- •history or presence of
- •cytochrome b5 reductase deficiency (previously called methemoglobin
- •reductase deficiency) or
- •other diseases that puts them at risk of methemoglobinemia. All participants
- •will be screened for
- •methemoglobin levels prior to randomization.
- •- Participants with a history of G6PD deficiency or other congenital or
- •autoimmune hemolytic
- •disorders. All participants will be screened for G6PD deficiency prior to
- •randomization.
- •- Major surgical procedure within 14 days prior to initiating study treatment
- •or anticipation of the
- •need for a major surgical procedure (other than RC) during the course of the
研究者
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