A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer

Exclusion Criteria

• •5. All patients must have at least one measurable lesion according to RECIST v1.1 criteria.
• •6. Eastern Cooperative Oncology Group (ECOG) performance status 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 to signature of ICF for this trial.
• •For patients confirmed as HIV positive, all of the following (a-d) applies:
• •1. CD4+ count ≥ 250 cells/μL
• •2. Undetectable viral load (local lab assessment)
• •3. Must be currently receiving Highly Active Antiretroviral Therapy
• •4. A HIV/Infectious Diseases specialist must be consulted or patient must be under the care of the HIV/Infectious Diseases specialist
• •8. Patients must be willing to allow programmed cell death ligand 1 (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. Exceptions may be considered after consultation with and approval by the Sponsor.
• •9. Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, for the entire duration of the trial treatment intake and for 6 months after the end of the trial treatment. A list of contraception methods meeting these criteria is provided in the patient information.
• •1. 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.
• •2. Major injuries and/or surgery or bone fracture within 4 weeks of start of treatment, or planned surgical procedures during the trial period.
• •3. 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).
• •Uncontrolled hypertension is defined as: blood pressure in rested and relaxed condition ≥ 140 mmHg, systolic or ≥ 90 mmHg diastolic (with or without medication)
• •4. Known inherited predisposition to bleeding or to thrombosis in the opinion of the investigator.
• •5. History of severe hemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis).
• •6. 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.
• •7. Prior treatment with anti-PD-1, anti-PD-L1, or anti CTLA-4 treatment