EUCTR2014-001285-10-AT进行中（未招募）1 期
An Open-Label, Multicenter Clinical Trial with Nivolumab (BMS-936558) Monotherapy in Subjects with Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC - CheckMate 171: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 171
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 950
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key Inclusion Criteria
- •a) Eastern Cooperative Oncology Group (ECOG) Performance Status
- •i) PS 0 to 1 (Subgroup1)
- •ii) PS 2 (Subgroup 2; minimum of 95 enrolled (81 treated subjects). The Scientific Steering Committee will provide guidance and scientific expertise on the
- •risk/benefit ratio following a Safety Management Plan).
- •b) Subjects with histologically or cytologically-documented SqNSCLC
- •who presented with stage IIIb/stage IV disease or who developed
- •recurrent or progressive disease following prior definitive therapy for
- •localized or local advanced disease. A fresh biopsy is not required to take
- •part in the study.
- •c) Subjects must have experienced disease recurrence or progression
- •during or after one prior platinum doublet-based chemotherapy regimen
- •for advanced or metastatic disease.
- •i) Maintenance therapy following platinum doublet-based
- •chemotherapy is not considered as a separate regimen of therapy
- •ii) Subjects who received platinum-containing adjuvant, neoadjuvant or
- •definitive chemoradiation therapy given for locally advanced disease,
- •and developed recurrent (local or metastatic) disease within 6 months of
- •completing therapy are eligible.
- •iii) Subjects with recurrent disease > 6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy
- •given for locally advanced disease, who also subsequently progressed
- •during or after a platinum doublet-based regimen given to treat the
- •recurrence, are eligible.
- •d) Subjects must have evaluable disease by CT or MRI per RECIST 1.1
- •criteria (radiographic tumor assessment performed within 28 days of
- •first dose of study drug) or clinically apparent disease that the
- •investigator can follow for response.
- •e) Subjects with CNS metastases:
- •i) Subjects are eligible if CNS metastases are treated and subjects are
- •neurologically returned to baseline (except for residual signs or
- •symptoms related to the CNS treatment) for at least 2 weeks prior to
- •first dose. In addition, subjects must be either off corticosteroids or on a
- •stable or decreasing dose of 10 mg daily prednisone (or equivalent)
- •ii) Subjects are eligible if they have previously untreated CNS metastases that are neurologically asymptomatic. In addition, subjects must be either off corticosteroids or on a stable or decreasing dose of < or = 10 mg daily prednisone (or equivalent)
- •Age and Reproductive Status
- •a) Males and Females, ages 18 or older
- •b) Women of childbearing potential (WOCBP) must have a negative
- •serum or urine pregnancy test (minimum sensitivity 25 IU/L or
- •equivalent units of HCG) within 24 hours prior to the start of study drug
- •c) Women must not be breastfeeding
- •d) WOCBP must agree to follow instructions for method(s) of
- •contraception for the duration
- •of treatment with nivolumab plus approximately 5 half-lives of
- •nivolumab plus 30 days (duration of ovulatory cycle) for a total of 5
- •months post-treatment completion.
- •e) Males who are sexually active with WOCBP must agree to follow
- •instructions for method(s) of contraception for the duration of treatment
- •with nivolumab plus approximately 5 half-lives of the study drug plus 90
- •days (duration of sperm turnover) for a total of 7 months post-treatment
- •completion.
- 另有 4 项未显示
排除标准
- •Key exclusion criteria:
- •a) Subjects with untreated, symptomatic CNS metastases are excluded
- •b) Subjects with carcinomatous meningitis are excluded.
研究者
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