IRB #

STUDY00017753

Title

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 (LA HNSCC)

Principal Investigator

Jeremy Cetnar

Study Purpose

The purpose of this study is to compare any good and bad effects of using pembrolizumab (the study drug) along with the usual surgery and radiation plus chemotherapy with or without cisplatin to using the usual surgery and radiation plus chemotherapy approach alone with or without cisplatin

Medical Condition(s)

Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

Eligibility Criteria

Male/Female participants of at least 18 years of age

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

Participants in Group A will receive the study drug for about 1 year as long as their cancer does not get worse or have side effects. Participants in Group B will receive the standard care for 4 months as long as their cancer does not get worse or have side effects.

You will be asked to come in for a safety follow-up visit about 30 days after stopping treatment. Once you complete the safety follow-up visit, and if your cancer has not progressed, your disease condition will be monitored by imaging scans for about the next 5 years. Scans will be obtained about once every 12 weeks for the first 3 years and about once every six months for the next 2 years.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

Merck Sharp & Dohme Corp

Recruitment End

11/30/2030

Compensation Provided

No