NL-OMON56458招募中3 期
A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer - CA209-901
Bristol-Myers Squibb0 个研究点目标入组 70 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
- 70
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
- •Histological or cytological evidence of metastatic or surgically unresectable
- •transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis,
- •ureter, bladder or urethra. Minor histologic variants (< 50% overall) are
- •acceptable (TCC must be the dominant histology).
- •Measurable disease by CT or MRI per RECIST 1.1 criteria.
- •No prior systemic chemotherapy for metastatic or surgically unresectable UC
- •with the exception of prior intravesical therapy completed more than 4 weeks
- •prior to initiation of study treatment or prior neoadjuvant chemotherapy,
- •radiation or prior adjuvant platinum-based chemotherapy or radiation following
- •radical cystectomy with recurrence >= 12 months from completion of therapy.
- •Cisplatin-ineligible participants will be defined by impaired renal function,
- •hearing loss or peripheral neuropathy
- •Participants must provide a fresh tumor biopsy (<3 months) from the disease
- •site. If the primary site is not available (ie, radical cystectomy), a
- •fresh biopsy from a metastatic site should be submitted.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- •Adequate hematologic and liver function
- •Prior palliative radiotherapy must have been completed at least 2 weeks
- •prior to study drug
- •administration. Participants must have measurable disease outside the
- •radiation field to be
- •eligible and the tumor sample be collected before (but not after)
- •palliative RT if it is from
- •the irradiated area. Participants with progression in a previously
- •radiated field will also be
排除标准
- •Disease that is suitable for local therapy administered with curative intent.
- •Presence of active brain metastases or leptomeningeal metastases
- •Patients who are HIV positive
- •Patients who are hepatitis B or C positive
- •Prior malignancy active within the previous 3 years except for locally
- •curable cancers
- •Participants must have recovered from the effects of major surgery requiring
- •general anesthetic or significant traumatic injury at least 14 days before
- •randomization or treatment assignment.
- •Uncontrolled adrenal insufficiency.
- •Any other serious or uncontrolled medical disorder or illness that may
- •increase the risk associated with study participation or study drug
- •administration, impair the ability of the participant to receive protocol
- •therapy, or interfere with the interpretation of study results.
- •Participants may not have received live/attenuated vaccines within 30 days
- •prior to first study treatment.
- •Treatment with botanical preparations intended for general health support or
- •to treat the disease under study within 2 weeks prior to first study treatment.
研究者
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