Medical Professionals

For Medical Professionals - Active8

Active8 Trial Now Enrolling

Active8 Trial Design

A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy Plus Cetuximab in Combination with VTX-2337 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Trial Design for Active8 for Head and Neck Cancer

Primary Endpoint:

  • Progression-free survival

Key Secondary Endpoint:

  • Overall survival

Key Inclusion Criteria:

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
  • Locoregionally recurrent or metastatic SCCHN; no prior treatment for their recurrent or metastatic disease
  • At least one measurable lesion as defined by RECIST v1.1 on screening CT or MRI
  • ECOG performance status of 0 or 1

Study Rationale:

The use of the epidermal growth factor receptor (EGFR)-specific monoclonal antibody cetuximab in combination with platinum and 5-FU based chemotherapy has demonstrated marked clinical benefit  in locally advanced and recurrent SCCHN patients as reported by Vermorken, et al in the New England Journal of Medicine, 2008. The addition of cetuximab to platinum-doublet chemotherapy significantly improved overall survival from 7.4 months to 10.1 months, establishing a new standard-of-care in the management of locally recurrent and metastatic SCCHN cancer. Despite these improvements, there remains a need for more effective therapy for this hard-to-treat population.

One approach to enhance the efficacy of the standard-of-care regimen could be to add the TLR8 agonist, motolimod, to promote an antitumor immune response. Preclinical and early clinical data with motolimod has demonstrated enhanced killing of SCCHN cells in combination with cetuximab, and enhanced antitumor effects in combination with some chemotherapies. Active8 will test the hypothesis that the addition of motolimod to the cetuximab plus platinum/5-FU regimen in patients with locally recurrent or metastatic SCCHN will be beneficial without dramatically increasing the toxicity of the drug combination.

For Additional Information:

For a complete list of Active8 sites, please visit www.clinicaltrials.gov. If you are interested in participating in the study, please contact active8info@ventirx.com.