metastatic squamous cell carcinoma of the anal canal MedDRA version: 21.1 Level: PT Classification code 10055096 Term: Anal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: BI 836880
Product Code: BI 836880
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BI 836880
Current Sponsor code: BI 836880
Other descriptive name: BI 836880
Concentratio
Sponsors
SCS Boehringer Ingelheim Comm. V
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
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 > 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to assess anti-tumour activity of BI 754091 as a 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.;Secondary Objective: Not applicable;Primary end point(s): 1) Objective response (OR);Timepoint(s) of evaluation of this end point: 1) up to 3.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Duration of objective response (DoR) 2) Progression-free survival (PFS) 3) Overall survival (OS) 4) Disease control (DC) 5) Adverse events (AEs) from the time of treatment initiation until the end of the REP 6) Drug related AEs from the time of treatment initiation until the end of the REP 7) Drug related AEs leading to dose reduction of BI 836880 and/or discontinuation of study treatment;Timepoint(s) of evaluation of this end point: 1) up to 3.5 years 2) up to 3.5 years 3) up to 3.5 years 4) up to 3.5 years 5) up to 3.5 years 6) up to 3.5 years 7) up to 3.5 years | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed