A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
← catalyst calendarNCT06769698 · readout in 655 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
120estimated
Sites
32
Countries
Australia, France, Italy +2
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 | 2026-04-14 | actual | When the study began enrolling |
| Primary completion | 2028-06-04 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-12-28 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Head and Neck Squamous Cell Carcinoma (HNSCC)
Interventions
- Drug: FDC fianlimab+cemiplimab — also filed as REGN3767, REGN2810, Libtayo
- Drug: Cemiplimab — also filed as R2810, Libtayo
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFOverall Response Rate (ORR)
measured Up to 90 days after last study treatment, approximately 58 months
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