NL-OMON50342已完成2 期
A phase II study of the anti-PDL1 antibody atezolizumab, bevacizumab and acetylsalicylic acid to investigate safety and efficacy of this combination in recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal adenocarcinoma - EORTC 1508
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
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
- •- Recurrent, histologically proven, platinum-resistant, epithelial ovarian,
- •fallopian tube and primary peritoneal cancer in advanced or metastatic stage.
- •Histological diagnosis by image guided biopsy, laparoscopy or laparotomy.
- •Tumors diagnosed on cytology only and borderline tumors are excluded.
- •- At least one lesion accessible to biopsy without putting patient at risk
- •- WHO PS: 0-2 for patients having received no more than two previous lines of
- •therapy. WHO PS: 0-1 for patients having received >2 previous lines of therapy
- •- Prior chemotherapy or bevacizumab:
- •* No prior treatment with hyperthermic intraperitoneal chemotherapy
- •(HIPEC) is allowed
- •* Any number of platinum-based chemotherapy lines are allowed but a
- •maximum of 2 previous non-platinum containing lines
- •* Prior treatment with bevacizumab or other targeted agent against VEGF or
- •VEGF receptor is allowed, but at least 18 weeks must have elapsed since their
- •last administration
- •* Eligible patients with * 2 previous treatment lines must have been
- •previously exposed to bevacizumab or other targeted agents against VEGF or VEGF
- •- Patients may have had prior therapy providing the following conditions are
- •* Radiation therapy: recovery period of 14 days prior to the first study
- •treatment; exception: single fraction radiotherapy with the indication of pain
- •* Systemic anti-tumoral treatment: wash-out period of 21 days prior to the
- •first study treatment
- •- Recovery from any toxic effects of prior therapy to * Grade 1 per the
- •National Cancer Institute Common Terminology Criteria for Adverse Events (NCI
- •CTCAE v4.0) except fatigue or alopecia
- •- Absence of any psychological, familial, sociological or geographical
- •condition potentially hampering compliance with the study protocol
- •- Signed Informed Consent Form
排除标准
- •- Age < 18 years
- •- Life expectancy of < 12 weeks
- •- No adequate hematologic and end-organ function
- •- Use of acetylsalicylic acid, NSAIDs or other COX-2 inhibitors that cannot be
- •stopped at baseline and for the whole duration of the study. Occasional use is
- •- History of bowel obstruction related to abdominal fistula, tracheoesophageal
- •fistula, gastrointestinal perforation or intra-abdominal abscess.
- •- Clinical symptoms of recent bowel obstruction or paralytic ileus, but
- •excluding postoperative obstruction (within 4 weeks after abdominal surgery),
- •or evidence of recto-sigmoid involvement by pelvic examination or bowel
- •involvement on CT scan
- •- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation
- •of study treatment, or anticipation of need for such a vaccine during
- •atezolizumab treatment or within 5 months after the final dose of atezolizumab.
研究者
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