NL-OMON45600撤回不适用
Phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer - PDR001 and regorafenib in MSS colorectal cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- ovartis
- 入组人数
- 6
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. Metastatic microsatellite stable colorectal adenocarcinoma.
- •2. Subjects must provide a newly obtained or an archival tumor sample corresponding to CRC diagnosis (primary tumor) with sufficient tissue quality for analysis.
- •3. Subjects must provide a newly obtained tumor tissue sample from a metastatic site.
- •4. At least one measurable lesion.
- •5. Previously treated with two prior regimen as per standard of care and have experienced disease progression.
- •6. ECOG performance status 0-1
排除标准
- •1. High level Microsatellite Instable (MSI-H) colorectal adenocarcinoma as defined per local standard of care testing.
- •2. Metastatic disease amenable to be resected with potentially curative surgery.
- •3. Chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study treatment.
- •4. Prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibodies, other checkpoint inhibitors.
- •5. Any untreated CNS lesion. Exceptions: see protocol page 39.
- •6. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
- •7. Use of G-CSF and comparable, see protocol page 39 for details.
- •8. Systemic chronic steroid therapy (* 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to start of study treatment.
- •9. History of severe hypersensitivity reactions to other monoclonal antibodies, see protocol page 39 for details.
- •10. HIV positive, HBsAg positive, hepatitis positive.
- •11. Active, known or suspected autoimmune disease or a documented history of autoimmune disease, see protocol page 40 for details.
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