Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers

Other illness

• Is at high risk of intracranial bleeding in the opinion of the investigator
• Known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)
• Part 1 participants with cancer and Part 2 additional exclusion criteria:
  • Has acute leukemia or myelodysplastic syndrome
  • Has primary brain tumor
  • Has brain metastases as described in the protocol

Other

• Contraindication to anticoagulation in the opinion of the investigator
• Life expectancy of \< 6 months
• Part 1 additional exclusion criteria:
  • Has a symptomatic PE
  • Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
• Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol
  • Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study intervention
• In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid or select hematologic tumor (other than basal-cell or squamous-cell carcinoma of the skin alone) as described in the protocol
• Part 1 additional criteria:
  • Has newly diagnosed symptomatic lower extremity DVT or incidentally-detected proximal lower extremity DVT (eg, popliteal or femoral) within 5 days (120 hours) of randomization (with imaging confirmation)
  • Anticoagulation therapy with a therapeutic dose of a Direct Oral Anticoagulant (DOAC) for at least 3 months is indicated for the newly diagnosed proximal lower extremity DVT
• Part 2 additional criteria:
  • Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol
  • Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE