A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT03978689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line or CUE-101 Combination Therapy With Pembrolizumab in First Line Patients With HPV16+ Recurrent/Metastatic HNSCC
Study identification
- NCT ID
- NCT03978689
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Cue Biopharma
- Industry
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Interventions
- CUE-101 Drug
- KEYTRUDA®, Pembrolizumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 29, 2019
- Primary completion
- Jan 3, 2026
- Completion
- Jan 3, 2026
- Last update posted
- Jan 21, 2026
2019 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 16
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85719 | — |
| Stanford University Medical Center | Palo Alto | California | 94305 | — |
| Yale School of Medicine | New Haven | Connecticut | 06510 | — |
| George Washington University Cancer Center | Washington D.C. | District of Columbia | 20037 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Affiliated Oncologists, LLC | Chicago | Illinois | 33612 | — |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 20231 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 48197 | — |
| Barbara Karmanos Cancer Center/ Wayne State University School of Medicine | Detroit | Michigan | 48201 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10017 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| Vanderbilt-Ingram Cancer Center (VICC) | Nashville | Tennessee | 37232 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Washington School of Medicine | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03978689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2026 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03978689 live on ClinicalTrials.gov.