Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC

Exclusion criteria

• ✕. Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• ✕. Subject has a clinically active brain metastases or leptomeningeal metastases. Participant who has a previously treated brain metastases or untreated asymptomatic brain metastases ≤5 mm may participate provided that they are radiologically stable (ie, without evidence of progression based on imaging during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.
• ✕. Subject has had an allogenic tissue/solid organ transplant.
• ✕. Subjects with electronic pacemakers or defibrillators.
• ✕. Subject who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• ✕. Subject has active hepatitis B (defined as HBsAg reactive) or active hepatitis C (defined as HCV RNA \[qualitative\] is detected). Note: Participant with a history of HBV or HCV controlled by ongoing viral suppression therapy is allowed.
• ✕. Subject has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• ✕. Subject has an active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs).