New hope for HPV+ head and neck cancer: experimental drug CUE-101 tested

NCT ID NCT03978689

Completed Disease control Sponsor: Cue Biopharma Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new drug called CUE-101, alone or with pembrolizumab, in 80 adults with HPV16-positive head and neck cancer that had spread or returned. The main goals were to check safety and find the right dose. Researchers also looked at whether the drug helped shrink tumors. This is a first step to see if the approach is promising.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma human papillomavirus-related squamous cell carcinoma oropharynx squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEAD AND NECK CANCER HPV-POSITIVE OROPHARYNGEAL SQUAMOUS CELL CARCINOMA HPV-RELATED CARCINOMA

Contacts and locations

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Locations

Affiliated Oncologists, LLC

Chicago, Illinois, 33612, United States
Barbara Karmanos Cancer Center/ Wayne State University School of Medicine

Detroit, Michigan, 48201, United States
Emory University School of Medicine

Atlanta, Georgia, 30322, United States
Gabrail Cancer Center

Canton, Ohio, 44718, United States
George Washington University Cancer Center

Washington D.C., District of Columbia, 20037, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 20231, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
Stanford University Medical Center

Palo Alto, California, 94305, United States
University of Arizona

Tucson, Arizona, 85719, United States
University of Michigan

Ann Arbor, Michigan, 48197, United States
University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
University of Washington School of Medicine

Seattle, Washington, 98195, United States
Vanderbilt-Ingram Cancer Center (VICC)

Nashville, Tennessee, 37232, United States
Washington University

St Louis, Missouri, 63110, United States
Yale School of Medicine

New Haven, Connecticut, 06510, United States

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