EUCTR2019-004749-33-IT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 -
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 120 人开始时间: 2021年1月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •- 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
相似试验
进行中（未招募）
1 期
A study to test BI 754091 alone or in combination with BI 836880 in people who have advanced anal cancermetastatic squamous cell carcinoma of the anal canalMedDRA version: 21.1Level: PTClassification code 10055096Term: Anal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004749-33-GBBoehringer Ingelheim Limited120
进行中（未招募）
1 期
A study to test BI 754091 alone or in combination with BI 836880 in people who have advanced anal cancermetastatic squamous cell carcinoma of the anal canalMedDRA version: 21.1Level: PTClassification code 10055096Term: Anal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004749-33-DEBoehringer Ingelheim Pharma GmbH & Co. KG120
进行中（未招募）
1 期
A study to test BI 754091 alone or in combination with BI 836880 in people who have advanced anal cancermetastatic squamous cell carcinoma of the anal canalMedDRA version: 21.1Level: PTClassification code 10055096Term: Anal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004749-33-LVBoehringer Ingelheim120
进行中（未招募）
1 期
A study to test BI 754091 alone or in combination with BI 836880 in people who have advanced anal cancermetastatic squamous cell carcinoma of the anal canalMedDRA version: 21.1Level: PTClassification code 10055096Term: Anal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004749-33-NLBoehringer Ingelheim120
进行中（未招募）
1 期
A study to test BI 754091 alone or in combination with BI 836880 in people who have advanced anal cancerEUCTR2019-004749-33-FRBoehringer Ingelheim120