Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT

Exclusion Criteria

• •1. Prior therapy for the disease with chemotherapy and/or an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
• •2. Patients who have received a live vaccine within 30 days prior to the first dose of study drug.
• •Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Inactivated rabies vaccines are allowed.
• •3. Patients who have had an allogenic tissue/solid organ transplant.
• •4. Patient who has received more than one cycle of platinum-based chemotherapy, or any prior systemic anti-cancer therapy including investigational agents for the SCCOHT. (Patients could be included after one cycle of platinum-based therapy).
• •5. Patients who have a known diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
• •6. Patients who have a known additional malignancy that is progressing or has required active treatment within the past 5 years.
• •Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
• •7. Patients who have a contraindication to any component of cisplatin, adriamycine, vepeside and cyclophosphamide.
• •Note: Investigators must use the local label for contraindications, prohibited medications, and precautions for use.
• •8. Patients who have severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or any of its excipients (refer to the IB for a list of excipients).
• •9. Patients who have a known severe hypersensitivity (Grade 3 or higher) to any of the study chemotherapy agents and/or to any of their excipients (refer to the approved product label(s) for a list of excipients).
• •10. Patients who have an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• •11. Patients who have a history of (non-infectious) pneumonitis/ interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease that requires steroids.
• •12. Has an active infection requiring systemic therapy.
• •13. Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
• •14. Has a history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or active hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.
• •15. Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
• •16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
• •17. Has a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study.
• •18. Breastfeeding women
• •19. Participation in another clinical study with an investigational product 30 days prior and during the treatment course, and 30 days after end of treatment.