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NCT04966481 · ClinicalTrials.gov registry record · Phase 3
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
A Phase 3 study of HPV-unrelated Head and Neck Squamous Cell Carcinoma, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 81
- Enrollment target
- 4
- Study locations
NCT04966481: Recruiting Phase 3 study of HPV-unrelated Head and Neck Squamous Cell Carcinoma, sponsored by Washington University School of Medicine.
NCT04966481 is a Phase 3 study of HPV-unrelated Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 81 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04966481, a Phase 3 study of HPV-unrelated Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 81 participants
- Enrollment target
- 4
- Study locations
Study Summary
This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as monotherapy or in combination with other therapy).
Primary Outcome
-Defined as the time from the date of treatment to the date of death, censored at the last follow-up otherwise.
Conditions Studied
Interventions
- DRUG Cetuximab
- DRUG Palbociclib
Study Locations (4)
Missouri
- Saint Luke's Hospital - Kansas City
- Washington University School of Medicine - St Louis
North Dakota
- Sanford Roger Maris Cancer Center - Fargo
South Dakota
- Sanford Medical Center - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2022-04-06 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 3 |
What NCT04966481 shows while recruiting
NCT04966481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with HPV-unrelated Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Cetuximab is the first listed.
NCT04966481 reports a single indexed study location in Missouri, North Dakota, South Dakota.
Frequently Asked Questions
What is clinical trial NCT04966481 about?
NCT04966481 is a clinical study titled "Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor". This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC...
What is the current status of trial NCT04966481?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 81 participants. The study started on 2022-04-06. Estimated completion is 2028-02-28.
What conditions does trial NCT04966481 study?
This clinical trial studies the following conditions: HPV-unrelated Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04966481?
The interventions under investigation include: Cetuximab (DRUG), Palbociclib (DRUG).
Who is sponsoring clinical trial NCT04966481?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04966481 being conducted?
This trial has 4 study locations across Missouri, North Dakota, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04966481's enrollment target sits among peer trials
81 1753rd of 2000 higher than 246 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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