RecruitingPhase 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

United States410 participantsStarted 2024-01-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors
✕. 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates
✕. 4 weeks (28 days) for cell therapies
✕. 2 weeks (14 days) for radiation therapy

What they're measuring

To compare the efficacy by overall survival of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)

Timeframe: From Randomization until death from any cause (Approximately 44 months)

Trial details

NCT IDNCT06064877

SponsorAVEO Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Clinical Trials Office

+1.857.400.0101 clinical@aveooncology.com

View on ClinicalTrials.gov More Metastatic Head-and-neck Squamous-cell Carcinoma trials