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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called "study drugs" in this form. The study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of each study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) individually (which could make the study drugs less effective or could lead to side effects) * Compatible research to better understand the study drugs and HNSCC
Study identification
- NCT ID
- NCT06769698
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
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
- Aug 20, 2026
2026 – 2030
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90024 | Recruiting |
| Samuel Oschin Cancer Center | Los Angeles | California | 90048 | Recruiting |
| Orlando Health | Orlando | Florida | 32806 | Recruiting |
| Emory University School of Medicine | Atlanta | Georgia | 30308 | Recruiting |
| Northwestern University | Evanston | Illinois | 60208 | Recruiting |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | Recruiting |
| Henry Ford Cancer Institute/Henry Ford Health System | Detroit | Michigan | 48202 | Recruiting |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | Recruiting |
| University of Rochester | Rochester | New York | 14642 | Recruiting |
| Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | Recruiting |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | Recruiting |
| Joe Arrington Cancer Research & Treatment Center | Lubbock | Texas | 79410 | Recruiting |
| Renovatio Clinical | The Woodlands | Texas | 77380 | Recruiting |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | Recruiting |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298 | 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 17 non-U.S. sites.
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 Aug 20, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06769698 live on ClinicalTrials.gov.