Hemopurifier Plus Pembrolizumab in Head and Neck Cancer

Exclusion Criteria

• •1. Patients with salivary gland SCC or cutaneous SCC will be excluded
• •2. Has received systemic therapy (chemotherapy, immunotherapy, investigational therapy) for the treatment of recurrent/metastatic disease. Systemic therapy given concurrent with radiation treatment in the recurrent setting does not exclude the patient.
• •3. Untreated brain metastasis or leptomeningeal metastasis.
• •4. Tumor invades into the internal carotid artery or other major blood vessels whereby the treating investigator feels anti-coagulation is contraindicated.
• •5. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (Prednisone \> 10mg or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• •6. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.
• •7. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.
• •8. Has an active infection requiring systemic therapy.
• •9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •10. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
• •11. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) in the recurrent/metastatic setting. Patients that received any of these agents in the upfront curative intent setting can be enrolled as long as it has been 1 year since the last dose.
• •12. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• •13. Has known active Hepatitis B or active Hepatitis C
• •14. Has received a live vaccine within 30 days prior to the first dose of trial treatment.
• •15. Concurrent therapy with an angiotensin-converting enzyme (ACE) inhibitor. ACE inhibitors must be discontinued at least 14 days prior to initiation of each Hemopurifier treatment and remain discontinued for 24 hours post treatment.
• •16. Systolic blood pressure less than 100 on at least 2 readings
• •17. Subjects with electro-cardiograms (ECG) showing clinically significant abnormalities.
• •18. Recent history of bleeding or bleeding disorders or any condition whereby in the opinion of the treating investigator giving anti-coagulation during the Hemopurifier treatment would be contraindicated
• •19. Any disorder or condition that in the opinion of the treating investigator would not be able to tolerate dialysis catheter placement, blood volume losses during Hemopurifier treatment or research blood draws.
• •20. History of heparin allergy or heparin induced thrombocytopenia.
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