NL-OMON49049撤回2 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 - A study of BI 754091 and with BI 836880 in pt with anal cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 3
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
- •1) Signed and dated written Informed Consent Form (ICF) in accordance with
- •ICH-GCP and local legislation prior to admission to the trial.
- •2) Patients *18 years of age or over the legal age of consent in countries
- •is greater than 18 years at the time of signature of the ICF.
- •3) Patients must have histologically or cytologically documented surgically
- •unresectable
- •locally-advanced or metastatic SCCA.
- •4) Patients with loco-regional anal cancer as initial diagnosis must have
- •unresectable
- •progressive locally advanced or metastatic SCCA after failure of at least one
- •not more than two lines) of previous systemic treatment unless ineligible for or
- •intolerant to this systemic therapy.
- •Note 1: the primary treatment (chemoradiotherapy) for loco-regional disease is
- •considered as a previous line of systemic treatment
- •Note 2: If palliative radiotherapy was given, this radiotherapy must have been
- •completed at least 30 days prior to the start of the trial treatment and lesions
- •previously receiving palliative radiotherapy must not be selected as target
- •lesions for
- •RECIST 1.1 evaluation during this trial.
- •Patients with metastatic anal cancer as initial diagnosis (no prior treatment
- •loco-regional cancer) must have failed one line of previous systemic treatment
- •(chemotherapy ± radiotherapy) for the metastatic anal cancer unless ineligible
- •intolerant to this systemic treatment. (Patients with metastatic anal cancer as
- •diagnosis who have received two or more lines of systemic treatment for the
- •anal cancer are not eligible for the study.)
- •5) All patients must have at least one measurable lesion according to RECIST
- •6) Eastern Cooperative Oncology Group performance status [ECOG, R01-0787]
- •score 0 to 1
- •7) All patients must be willing to undergo blood testing for human
- •immunodeficiency
- •virus (HIV) presence in the blood if not tested within the past 6 months prior
- •signature of ICF for this trial.
- •For patients confirmed as HIV positive, all of the following (a-d) applies:
- •a) CD4+ count * 250 cells/*L
- •b) Undetectable viral load (local lab assessment)
- •c) Must be currently receiving Highly Active Antiretroviral Therapy
- •d) A HIV/Infectious Diseases specialist must be consulted or patient must be
- •the care of the HIV/Infectious Diseases specialist
- •8) 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
- •be collected via eCRF. Exceptions may be considered after consultation with and
- •approval by the Sponsor.
- •9) Male or female patients. Women of childbearing potential (WOCBP)1 and men
- •father a child must be ready and able to use highly effective methods of birth
- 另有 5 项未显示
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
- •- 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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