Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC

Inclusion Criteria:

1. Histologically confirmed locally advanced, recurrent or metastatic squamous cellcarcinoma of the head and neck that is considered incurable by local therapies

2. Measurable disease evaluated by RECIST criteria version 1.1

3. WHO performance status of 2

4. Life expectancy >12 weeks

5. Aged ≥18 years of age

6. Adequate bone marrow function

7. Adequate renal function

8. Adequate liver function

9. Willing to use highly effective contraception for the duration of trial treatmentand for 120 days after completion of treatment

10. Able to give informed consent, indicating that the patient has been informed of andunderstands the experimental nature of the study, possible risks and benefits, trialprocedures, and alternative options

11. Willing and able to comply with the protocol for the duration of the study,including the treatment plan, investigations required and follow up visits

Exclusion Criteria:

1. Patients with undifferentiated nasopharyngeal or sino-nasal cancers

2. Disease suitable for treatment with curative intent

3. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent

4. Any investigational agents within 4 weeks prior to registration

5. Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration

6. Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks priorto registration

7. Patients with concurrent or previous malignancy that could compromise assessment ofthe primary or secondary endpoints of the trial

8. Women who are pregnant or breast feeding

9. Grade 3 or 4 peripheral neuropathy

10. Any serious and/or unstable pre-existing medical, psychiatric or other conditionthat, in the treating clinician's judgment, could interfere with patient safety orobtaining informed consent

11. Active central nervous system (CNS) metastases and/or carcinomatous meningitis

12. Active hepatitis B or C infection

13. Immunocompromised patients (e.g. known HIV positive status)

14. Prior organ transplantation including allogenic stem-cell transplantation

15. History of (non-infectious) pneumonitis/interstitial lung disease that requiredsteroids, or current pneumonitis/interstitial lung disease

16. Active infection requiring systemic therapy

17. Received a live vaccine within 30 days prior to registration

18. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any otherform of immunosuppressive therapy within 7 days prior to the first dose of trialtreatment

19. Active autoimmune disease that might deteriorate when receiving animmune-stimulatory agent.

20. Current use of immunosuppressive medication (exceptions apply) Refer to section 7.2for full list of eligibility criteria