QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy

Exclusion Criteria

• •1. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
• •2. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, \[subjects with mild rheumatoid arthritis that aren't currently receiving treatment for their disease are eligible for enrollment\], Addison's disease, or autoimmune disease associated with lymphoma).
• •3. History of organ transplant requiring immunosuppression.
• •4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• •5. Inadequate organ function, evidenced by the following laboratory results:
• •1. ANC \< 900 cells/mm3.
• •2. Platelet count \< 75,000 cells/mm3
• •3. Total bilirubin greater than twice the ULN (unless the subject has documented Gilbert's syndrome).
• •4. AST (SGOT) or ALT (SGPT) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases).
• •5. ALP levels \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \>10 × ULN in subjects with bone metastases).
• •6. Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
• •7. Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
• •8. Current chronic daily treatment (continuous for \> 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
• •9. Known hypersensitivity to any component of the study medication(s), including anaphylactic reaction to sulfur-containing medications.
• •10. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
• •11. Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to the start of treatment on this study, except for testosterone-lowering therapy in men with prostate cancer.
• •12. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• •13. Concurrent participation in any interventional clinical trial.
• •14. Pregnant and nursing women.