A PHASE 2 STUDY OF ALKS 4230 IN COMBINATION WITH ANTI-PD-1 (PEMBROLIZUMAB) IN PATIENTS WITH ADVANCED OR RECURRENT HEAD AND NECK SQUAMOUS CELL CANCER CURRENTLY ON TREATENT WITH ANTI-PD-(L)1 WITHOUT HAVING ACHIEVED A COMPLETE REMISSION

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Head & Neck Squamous Cell Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    To be considered for this trial the following criterias must be met. 1) Individuals must have a histologically or microscopic examination of tissue in order to study the manifestations of disease confirmed diagnosis of Head and neck squamous cell carcinoma region that is locally advanced or recurrent and no longer amenable to local surgical or radiation therapy or with evidence of metastatic disease. Both HPV(+) and HPV(-) individuals are allowed. 2) Must have had prior Programmed cell death protein (PD-1);Programmed death-ligand(PD-L1) inhibition therapy with anti-PD-(L)1 therapy as the most recent systemic therapy. 3) Must have disease that is measurable by RECIST v1.1 criteria and those with only 1 site of disease must be able to provide adequate tissue samples at time of biopsy.

You may not be eligible for this study if the following are true:

  • You will not be eligible for this trial if you have the following: 1) Patients that have a diagnosis of immunodeficiency or is receiving systemic steroid therapy (inhaled or topical steroids are allowable) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 2) Patients with active tuberculosis (TB; Bacillus tuberculosis). 3) Patients that have a hypersensitivity to pembrolizumab, ALKS 4230, or any of their excipients.


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