NL-OMON45572招募中不适用
A phase 1b, dose finding, open label study of the safety and tolerability of carboplatin-cyclophosphamide combined with atezolizumab, an antibody that targets programmed death ligand 1 (PD-L1), in patients with advanced breast cancer, ovarian, cervical and endometrial cancer. - PROLOG study
ederlands Kanker Instituut0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
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
- •1.Histological or cytological proof of advanced breast cancer (M1) or gynaecological (cervix (M1, FIGO IVA/IVB), ovarian (after recurrence on carboplatin and/or paclitaxel) or endometrial (T3-T4, FIGO IVA/IVB) cancer) cancer pre-treated with maximally one line of systemic chemotherapy in the advanced setting and any line of hormonal therapy for advanced disease and potentially benefitting from carboplatin-cyclophosphamide and atezolizumab. (prior (neo-) adjuvant chemotherapy is accepted and does not count as one line, since administered in early stage disease);
- •2. Maximally one line of platinum containing pre-treatment is allowed in either adjuvant or metastatic setting
- •3. Men and women >=18 years;
- •4. Able and willing to give written informed consent;
- •5. WHO performance status of 0 or 1;
- •6. Life expectancy >= 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;
- •7. Minimal acceptable safety laboratory values
排除标准
- •1. Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard (neo-)adjuvant chemotherapy, hormonal and immunotherapy;
- •2. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;
- •3. Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
- •4. Women who have a positive pregnancy test (urine/serum) and/or who ware breast feeding;
- •5. Unreliable contraceptive methods
研究者
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