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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 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. The trial reports 4 study locations across 3 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04966481
The ClinicalTrials.gov registry entry for NCT04966481 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Related
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