Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)

KEYNOTE-040
Head and Neck
Alexander Hantel, MD

Naperville

This is a study of pembrolizumab versus standard treatment (methotrexate, docetaxel, or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs progression-free survival and overall survival when compared to standard treatment.

Sponsor: Merck Sharp & Dohme Corp

https://clinicaltrials.gov/ct2/show/NCT02252042?term=KEYNOTE-040&rank=1

  • Have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies
  • Failure of prior platinum therapy
  • Female participants of childbearing potential must be willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120-180 days after the last dose of study therapy acccording to local standard of care
  • Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120-180 days after the last dose of study therapy according to local standard of care
  • No diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma

5-6 years

Pending IRB Approval for Recruiting
Interventional
III
Kathy Seymour, BSN
630-646-6050
630-646-6110
630-646-6075