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
Public ClinicalTrials.gov record NCT06769698. 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
Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression
Study identification
- NCT ID
- NCT06769698
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Regeneron Pharmaceuticals
- Industry
- Enrollment
- 120 participants
Conditions and interventions
Interventions
- Cemiplimab Drug
- FDC fianlimab+cemiplimab Drug
- Placebo 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
- Apr 13, 2026
- Primary completion
- Jun 3, 2028
- Completion
- Dec 27, 2030
- Last update posted
- May 5, 2026
2026 – 2030
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orlando Health | Orlando | Florida | 32806 | Recruiting |
| Emory University School of Medicine | Atlanta | Georgia | 30308 | Recruiting |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | Recruiting |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | Recruiting |
| Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | Recruiting |
| Joe Arrington Cancer Research & Treatment Center | Lubbock | Texas | 79410 | Recruiting |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06769698, 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 May 5, 2026 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06769698 live on ClinicalTrials.gov.