EUCTR2019-004749-33-NL进行中（未招募）1 期
An open label, randomized Phase II study of BI 754091 alone or in combination with BI 836880 in patients with chemotherapy resistant, unresectable, metastatic squamous cell carcinoma of the anal canal
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •- Signed and dated written Informed Consent Form (ICF) in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •- Patients =18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
- •- Patients must have histologically or cytologically documented surgically unresectable locally-advanced or metastatic SCCA.
- •- Patients with loco-regional anal cancer as initial diagnosis must have unresectable progressive locally advanced or metastatic SCCA after failure of at least one line (but not more than two lines) of previous systemic treatment unless ineligible for or intolerant to this systemic therapy.
- •- Patients with metastatic anal cancer as initial diagnosis must have failed one line of previous systemic treatment (chemotherapy ± radiotherapy) for the metastatic anal cancer unless ineligible for or intolerant to this systemic treatment.
- •- All patients must have at least one measurable lesion according to RECIST v1.1 criteria.
- •- Eastern Cooperative Oncology Group performance status [ECOG, R01-0787] score 0 to 1
- •- Patients must be willing to allow PD-L1 status assessment by one of following options. Preference is given to fresh tumour biopsy sample collection at baseline before receiving first trial medication. In case a fresh tumour biopsy cannot be obtained (e.g. inaccessible lesions or patient safety concern), archival tissue will be requested. If neither is available any previous historical information regarding PD-L1 status should be collected via eCRF.
- •- Further criteria apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 103
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •- Current or prior treatment with any systemic anti-cancer therapy or any investigational product (or device) either within 28 days or less than 5 half-lives (whichever is shorter) before start of trial treatment.
- •- Major injuries and/or surgery or bone fracture within 4 weeks of start of treatment, or planned surgical procedures during the trial period.
- •- Significant cardiovascular/cerebrovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > NYHA II).
- •- Known inherited predisposition to bleeding or to thrombosis in the opinion of the investigator.
- •- History of severe hemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis).
- •- Patients who require full-dose anticoagulation (according to local guidelines). No Vitamin K antagonist and other anticoagulation allowed; LMWH and acetylsalicylic acid (ASA) allowed only for prevention not for curative treatment.
- •- Prior treatment with anti-PD-1, anti-PD-L1, or anti CTLA-4 treatment
- •- Prior treatment with any antiangiogenic agent (e.g. bevacizumab, cediranib, aflibercept, vandetanib, XL-184, sunitinib, etc.)
- •- Further criteria apply.
研究者
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