Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC

Prior treatment

• Disease suitable for treatment with curative intent
• Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent
• Any investigational agents within 4 weeks prior to registration
• Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration
• Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to registration
• Prior organ transplantation including allogenic stem-cell transplantation
• Received a live vaccine within 30 days prior to registration
• Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent.
• Current use of immunosuppressive medication (exceptions apply) Refer to section 7.2 for full list of eligibility criteria

Other illness

• Patients with undifferentiated nasopharyngeal or sino-nasal cancers
• Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial
• Any serious and/or unstable pre-existing medical, psychiatric or other condition that, in the treating clinician's judgment, could interfere with patient safety or obtaining informed consent
• Active hepatitis B or C infection
• Immunocompromised patients (e.g. known HIV positive status)
• History of (non-infectious) pneumonitis/interstitial lung disease that required steroids, or current pneumonitis/interstitial lung disease
• Active infection requiring systemic therapy

Other

• Women who are pregnant or breast feeding
• Grade 3 or 4 peripheral neuropathy
• Active central nervous system (CNS) metastases and/or carcinomatous meningitis

• Histologically confirmed locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies
• Measurable disease evaluated by RECIST criteria version 1.1
• WHO performance status of 2
• Life expectancy \>12 weeks
• Aged ≥18 years of age
• Adequate bone marrow function
• Adequate renal function
• Adequate liver function
• Willing to use highly effective contraception for the duration of trial treatment and for 120 days after completion of treatment
• Able to give informed consent, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options
• Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits