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NCT06064877 · ClinicalTrials.gov registry record · Phase 3
A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma
A Phase 3 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by AVEO Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 410
- Enrollment target
- 20
- Study locations
NCT06064877 is a Phase 3 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by AVEO Pharmaceuticals. The registered enrollment target is 410 participants, above the 110-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (273% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT06064877, a Phase 3 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by AVEO Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 410 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Ficlatuzumab
- BIOLOGICAL Cetuximab
Study Locations (20)
New York
- Northwell Health Cancer Institute - Lake Success
- Manhattan Eye, Ear & Throat Hospital - New York
- Montefiore Medical Center - The Bronx
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- The University of Arizona Cancer Center - Tucson
Ohio
- University of Cincinnati - UC Health Barrett Cancer Center - Cincinnati
- Ohio State University, James Cancer Hospital and Solove Research Institute - Columbus
California
- University of California Los Angeles - Westwood, Los Angeles
Connecticut
- Yale School of Medicine - Smilow Cancer Hospital - New Haven
District of Columbia
- The George Washington University - Washington D.C.
Florida
- AdventHealth Medical Group Oncology & Hematology at Orlando - Orlando
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2024-01-11 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06064877
The ClinicalTrials.gov registry entry for NCT06064877 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 410 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 110-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (273% higher). The listed sponsor is AVEO Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06064877 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, Arizona, Ohio.
Frequently Asked Questions
What is clinical trial NCT06064877 about?
NCT06064877 is a clinical study titled "A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma". The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cet...
What is the current status of trial NCT06064877?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 410 participants. The study started on 2024-01-11. Estimated completion is 2027-11.
What conditions does trial NCT06064877 study?
This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06064877?
The interventions under investigation include: Placebo (OTHER), Ficlatuzumab (BIOLOGICAL), Cetuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06064877?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06064877 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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