A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal… (NCT04499352) | Clinical Trial Compass
WithdrawnPhase 2
A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer
Stopped: Not due to safety reasons (sponsor decision).
South Korea0Started 2020-09-14
Plain-language summary
The objective of this trial is to assess anti-tumour activity of BI 754091 as monotherapy and of BI 754091 in combination with BI 836880 in patients with unresectable or metastatic squamous cell carcinoma of the anal canal who progressed on or after chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 Squamous cell carcinoma of the anal canal (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.
✓. All patients must have at least one measurable lesion according to RECIST v1.1 criteria.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 1
✓. 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 to signature of ICF for this trial.
✓. CD4+ count ≥ 250 cells/μL
Exclusion criteria
✕. 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 \> New York Heart Association (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; Low-Molecular-Weight-Heparin (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 exclusion criteria apply.