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临床试验/NL-OMON53202
NL-OMON53202尚未招募2 期

A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1*POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER - CO44194

Roche Nederland B.V.0 个研究点目标入组 2 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
2
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

年龄范围
18 至 99（—）

入选标准

  • •Signed Informed Consent Form
  • •Age >= 18 years at the time of signing Informed Consent Form
  • •Metastatic or locally advanced unresectable, histologically documented TNBC
  • •(absence of HER2-over-expression, ER, and PgR expression by local assessment)
  • •Measurable disease per RECIST v1.1
  • •If metastatic disease (Stage IV), measurable disease outside of the bone
  • •Previously irradiated lesions can be considered as measurable disease only if
  • •disease progression has been unequivocally documented at that same lesion since
  • •No prior systemic therapy for metastatic or locally advanced unresectable TNBC
  • •Tumor PD-L1 expression as documented through central testing of a
  • •representative tumor tissue specimen.
  • •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see
  • •Appendix 9)
  • •More inclusion criteria are stated in protocol section 5.1

排除标准

  • •Pregnancy or breastfeeding, or intention of becoming pregnant during the
  • •study or within 4 months after the final dose of RO7247669 or pembrolizumab,
  • •and 6 months after the final dose of nab-paclitaxel.
  • •Poor venous access
  • •Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 as calculated through
  • •use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  • •History of malignancy within 5 years prior to consent, except for the cancer
  • •under investigation in this study and malignancies with a negligible risk of
  • •metastasis or death (e.g., 5-year OS rate > 90%)
  • •Symptomatic, untreated, or actively progressing central nervous system (CNS)
  • •More exclusion criteria are stated in the protocol section 5.2

研究者

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