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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: Recruiting Phase 3 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by AVEO Pharmaceuticals.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Overall survival (OS), defined as the time from the date of randomization to the date of death for any cause

Conditions Studied

Metastatic Head-and-neck Squamous-cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma

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

FieldValue
Enrollment Target 410 participants
Start Date 2024-01-11
Est. Completion 2027-11
Phase Phase 3
AVEO Pharmaceuticals

27 total trials

What NCT06064877 shows while recruiting

NCT06064877 is an interventional study that assigns participants to a tested intervention. The registered 410 participants enrollment target is mid-sized for trials with a published cap, above the 110-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (273% higher).

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 names 20 study sites across 16 states, led by 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.

Learn More About Clinical Trials

Similar trials for Metastatic Head-and-neck Squamous-cell Carcinoma

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 NCT06064877's enrollment target sits among peer trials

410 3rd of 24 higher than 22 of 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Head-and-neck Squamous-cell Carcinoma 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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More recruiting context for NCT06064877

Source: ClinicalTrials.gov NCT06064877, the US trial registry maintained by the National Library of Medicine. NCT06064877 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.