Ensayos clínicos

Inclusion criteria:

• Males and females aged ≥18 years (for Japan only: Age ≥20 years at time of signing Informed Consent Form) with histologically confirmed metastatic colorectal cancer (mCRC).
• Metastatic disease not amenable to surgical curative treatment and eligible to receive therapy with mFOLFOX6 (Leucovorin/5-Fluorouracil/Oxaliplatin) + bevacizumab.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Adequate hepatic, renal and bone marrow function.
• Further inclusion criteria apply.

Exclusion criteria:

• Prior systemic therapy for metastatic disease
• Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular endothelial growth factor (VEGF) or VEGF receptors, including Avastin® or Avastin® biosimilar
• Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
• Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 6 weeks prior to start of study treatment
• Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
• History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
• A thrombotic or hemorrhagic event ≤6 months prior to screening (includes hemoptysis, Gastrointestinal (GI) bleeding, hematemesis, central nervous system hemorrhage, epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and coronary artery disease)
• Further exclusion criteria apply