A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX)

Exclusion Criteria

• •1. Previous treatment with JX-594 or other vaccina vector based treatment .
• •2. Concomitant diseases/conditions (non exhaustive list):
• •1. Clinically significant immunodeficiency, such as HIV or active Hepatite B or C
• •2. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
• •3. History of severe exfoliative skins condition requiring systemic treatment for more than 4 weeks in the last two years.
• •4. active autoimmune disease for patients treated by avelumab
• •3. Active central nervous system metastasis (CNS)
• •4. Participation to a study involving a medical or therapeutic intervention in the last 30 days.
• •5. Previous enrolment in the present study.
• •6. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
• •7. Known hypersensitivity to any involved study drug or any of its formulation components.
• •8. Use of steroids (any route of administration), interferon/pegylated interferon or ribavirin that cannot be discontinued within 14 days prior to any JX-594 dose.
• •9. No prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 1 or Stage 2 cancer from which the patient is currently in complete remission or any other cancer from which the patient has been disease-free for 3 years.
• •10. Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g. requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months. (treatment by CP+JX)
• •11. Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments.
• •12. Pulse oximetry O2 saturation \< 90% at rest on room air.
• •13. Experienced a severe systemic reaction or side-effect as result of previous smallpox vaccination.
• •14. Cardiac disease: LVEF out of normal limits ; cumulative dose of anthracyclines in excess of 450 mg/m²
• •15. Known urinary tract obstruction
• •16. Household contact exclusions for patients enrolled: children\< 1 year old ; People with skin disease (e.g., eczema, atopic dermatitis and related diseases…), Immunocompromised hosts (severe deficiencies in cell-mediated immunity, including AIDS, organ transplant recipients, hematologic malignancies)
• •17. Vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivated vaccines.