Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC

Exclusion Criteria

• •1. Any of the following interventions within the specified time frame prior to radiation:
• •1. Radiation therapy within 21 days.
• •2. Cytotoxic chemotherapy within 21 days (capecitabine within 14 days).
• •3. Monoclonal antibodies within 21 days.
• •4. Administration of an investigational agent that is not expected to be cleared prior to initiation of radiation.
• •2. More than one prior line of chemotherapy in the locally advanced unresectable or metastatic setting.
• •3. Prior treatment with a taxane in the metastatic setting. Prior taxane in the curative setting is allowed if treatment was completed ≥ 6 months prior to metastatic recurrence.
• •4. Prior receipt of immune checkpoint inhibitor (PD-L1, PD-1 or CTLA-4 inhibitors) less than 12 mos from metastatic recurrence.
• •5. Patients with active collagen vascular disease (CVD), specifically systemic lupus erythematosus or scleroderma. Patients with a history of CVD without evidence of active disease are eligible for enrollment at the discretion of the study PI.
• •6. History of immunodeficiency, hypersensitivity to pembrolizumab or other medical contraindication to receipt of immunotherapy.
• •7. Has active, or history of, pneumonitis requiring treatment with corticosteroids.
• •8. Has a known history of active tuberculosis.
• •9. Has a known history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome - related illness (testing not required at screening).
• •10. Has known active hepatitis B (hepatitis B surface antigen reactive) or hepatitis C (qualitative HCV RNA is detected) (testing not required at screening).
• •11. Has received a live vaccine within 30 days prior to enrollment.
• •12. Has an active infection requiring treatment with oral or IV medication. Patients on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other criteria are met.
• •13. Autoimmune disease that has required systemic treatment in the past 2 years (ie. with the use of disease modifying agents, systemic corticosteroids, or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• •14. Symptomatic or uncontrolled central nervous system (CNS) metastases. Patients with treated brain metastasis with stable CNS imaging \> 28 days after radiation and no requirement for corticosteroids are eligible.
• •15. Receipt of corticosteroid therapy at greater than physiologic dosing in the investigator's opinion within 14 days of the start of radiation therapy.
• •16. For patients undergoing serial tumor biopsies, known bleeding diathesis or history of abnormal bleeding or require anti-coagulation therapy that cannot be interrupted for biopsy.
• •17. Patients with a separate active cancer diagnosis for which the patient has not been without evidence of disease for at least 2 years.
• •18. Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
• •19. Any severe concurrent disease or condition (including uncontrolled diabetes mellitus, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, or cardiac arrythmia) which, in judgment of the Investigator, would make the patient inappropriate for study participation.