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Treatment Study for Patients with Head and Neck Cancers

Clinical Trial Title: 
A multicenter, open-label, phase 2 study of Imprime PGG and pembrolizumab in subjects with advanced SCCHN who have failed pembrolizumab monotherapy or who are actively experiencing stable disease.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Mary Jo Fidler, MD
Clinical Trial Protocol Description: 

Study for Imprime PGG and pembrolizumab for subjects with advanced head and neck cancers who have failed pembrolizumab monotherapy or who are actively experiencing stable disease and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have signed an informed document prior to any study-specific procedures or treatment.
  • Are at least 18 years of age at time of consent.
  • Have histologically or cytologically confirmed diagnosis of SCCHN irrespective of PDL1 status, which is either inoperable and recurrent, or metastatic.
  • Have had up to 3 prior chemotherapy regimens for recurrent or metastatic disease.

You will be excluded from the study if any of the following criteria apply to you:

  • Have disease that is suitable for local therapy administered with curative intent.
  • Are currently participating in or have received an investigational agent or have used an investigational device within 4 weeks of the first dose of treatment.
  • Have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor.
  • Have a known history of active tuberculosis.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Ear, Nose and Throat
Head and Neck Cancer
Contact Phone: 
(312) 942-5183
Contact Name: 
Steffi Leung