Skip to main content

Merck 689: A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03765918

Background Information

This study is for patients with newly diagnosed, localized, and advanced Head and Squamous Cell Carcinoma and whose doctor has recommended surgery.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Have histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma as assessed by the investigator based on baseline imaging and clinical assessment that is either: Stage III oropharyngeal p16 positive that is T4 (N0-N2), M0 or Stage III or IVA oropharyngeal p16 negative or Stage III or IVA larynx/hypopharynx/oral cavity.
  • Be eligible for primary surgery based on investigator decision and per local practice. This decision must be validated by members of a multidisciplinary team, including the surgical oncologist, medical oncologist and radiation oncologist.
  • Additional eligibility in protocol.

Ineligibility Information

  • Has Stage T4B and/or N3 LA HNSCC and/or distant metastases.
  • Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary HNC
  • Additional ineligibility in protocol

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03765918