A study to test BI 754091 alone or in combination with BI 836880 inpeople who have advanced anal cancer
- Conditions
- metastatic 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)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-004749-33-IT
- Lead Sponsor
- BOEHRINGER-INGELHEIM ITALIA S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this trial is to assess anti-tumour activity of BI 754091<br>as a monotherapy and of BI 754091 in combination with BI 836880 in<br>patients with unresectable or metastatic squamous cell carcinoma of the<br>anal canal who progressed on or after chemotherapy.;Secondary Objective: Not applicable;Primary end point(s): Objective response (OR);Timepoint(s) of evaluation of this end point: up to 3.5 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Duration of objective response (DoR)<br>2) Progression-free survival (PFS)<br>3) Overall survival (OS)<br>4) Disease control (DC)<br>5) Adverse events (AEs) from the time of treatment initiation until the<br>end of the REP<br>6) Drug related AEs from the time of treatment initiation until the end of<br>the REP<br>7) Drug related AEs leading to dose reduction of BI 836880 and/or<br>discontinuation of study treatment;Timepoint(s) of evaluation of this end point: 1) up to 3.5 years<br>2) up to 3.5 years<br>3) up to 3.5 years<br>4) up to 3.5 years<br>5) up to 3.5 years<br>6) up to 3.5 years<br>7) up to 3.5 years