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A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma

Exploring a new treatment for certain head and neck cancers.

Recruiting
18 years and older
All
Phase 3

Study Goal: This study evaluates if the combination of two drugs, ficlatuzumab and cetuximab, works better than cetuximab alone for people with a specific type of head and neck cancer. This cancer is HPV-negative, which means it is not caused by the human papillomavirus. The study also checks for side effects.

Study Design: Participants are divided into three groups. Two groups receive different doses of ficlatuzumab and cetuximab, while the third group gets a placebo (a harmless pill) and cetuximab. A placebo is used to compare the effects of the actual drug. The study is double-blind, which means neither the participants nor the doctors know who is receiving which treatment, to make the results fair.

Eligibility: Participants must be 18 or older, have a confirmed diagnosis of this cancer type, and have previously tried other treatments without success.

  • Approximately 410 participants are expected.
  • Participants must commit to regular study visits.
  • There may be potential side effects from the drugs.

Discuss with your doctor to see if this study is right for you.

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

NCT06064877

AVEO Pharmaceuticals, Inc.

20 April 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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