A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma
← catalyst calendarSponsored by Cue Biopharma (industry) · CUE — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
80actual
Sites
17
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-07-30 | actual | When the study began enrolling |
| Primary completion | 2026-01-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-01-04 | actual | The whole study's end, after follow-up |
| First posted | 2019-06-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Head and Neck Cancer
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
- HPV-Related Carcinoma
Interventions
- Drug: CUE-101
- Drug: KEYTRUDA®, Pembrolizumab — also filed as Pembrolizumab
Primary outcomes
what the primary-completion date above is the date OFDose Limiting Toxicity
measured 36 months
Serum PK parameters for CUE-101
measured 36 months
Serum PK parameters for CUE-101
measured 36 months
Serum PK parameters for CUE-101
measured 36 months
Publications
- PMID 31964784 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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