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NCT06769698 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT06769698: Recruiting Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by Regeneron Pharmaceuticals.
NCT06769698 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC) that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 120 participants, below the 242-participant average among 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (50% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06769698, a Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cemiplimab
- DRUG FDC fianlimab+cemiplimab
Study Locations (2)
Nebraska
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists - Omaha
Texas
- Joe Arrington Cancer Research & Treatment Center - Lubbock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-03-31 |
| Est. Completion | 2030-12-28 |
| Phase | Phase 2 |
What NCT06769698 shows while recruiting
NCT06769698 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 242-participant average among 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma (HNSCC) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06769698 reports a single indexed study location in Nebraska, Texas.
Frequently Asked Questions
What is clinical trial NCT06769698 about?
NCT06769698 is a clinical study titled "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". 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 ...
What is the current status of trial NCT06769698?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2026-03-31. Estimated completion is 2030-12-28.
What conditions does trial NCT06769698 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma (HNSCC).
What interventions are being tested in trial NCT06769698?
The interventions under investigation include: Placebo (DRUG), Cemiplimab (DRUG), FDC fianlimab+cemiplimab (DRUG).
Who is sponsoring clinical trial NCT06769698?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06769698 being conducted?
This trial has 2 study locations across Nebraska, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Squamous Cell Carcinoma (HNSCC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06769698's enrollment target sits among peer trials
120 8th of 14 higher than 7 of 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma (HNSCC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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