Study on Ficlatuzumab and Cetuximab for Recurrent or Metastatic HPV-Negative Head and Neck Cancer

Sponsor: AVEO Pharmaceuticals, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06064877

Provider View

This clinical trial is testing whether the combination of ficlatuzumab and cetuximab is more effective than cetuximab alone in treating recurrent or metastatic HPV-negative head and neck cancer. The study aims to see if this combination can help patients live longer or delay the progression of their cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining the drugs ficlatuzumab and cetuximab is better at controlling recurrent or metastatic HPV-negative head and neck cancer compared to using cetuximab alone. Researchers want to see if this combination can help patients live longer or keep their cancer from getting worse for a longer time.

Description

This study involves participants with recurrent or metastatic HPV-negative head and neck squamous cell carcinoma (HNSCC) who have not responded to previous treatments, including immune checkpoint inhibitors and platinum-based chemotherapy. Participants will be randomly assigned to one of three groups: two groups will receive different doses of ficlatuzumab combined with cetuximab, and the third group will receive a placebo with cetuximab. The study will include about 410 participants and will compare the effectiveness and safety of these treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
  • For those with oropharyngeal cancer, must be HPV-negative.
  • Have at least one measurable tumor that has not been treated with radiation, or if treated, must show clear progression.
  • Must have previously tried and not responded to treatments with anti-PD-1/PD-L1 immune checkpoint inhibitors and platinum-based chemotherapy.
  • The cancer must be considered inoperable and incurable.
  • Be in good overall health with a performance status of 0 or 1 and a life expectancy of at least 12 weeks.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Agree to use effective birth control during the study and for at least 60 days after the last treatment.
  • Be able to provide written informed consent and follow study requirements.
  • Patients with feeding tubes can participate.
  • Must provide a tissue sample for analysis within 60 days of starting the study.

Exclusion Criteria

  • Have severe allergies or reactions to the study drugs or similar proteins.
  • Have untreated or uncontrolled brain cancer spread.
  • Have received other investigational drugs or treatments recently without a proper washout period.
  • Have unresolved significant side effects from previous cancer treatments, except for hair loss.
  • Have serious heart conditions or recent heart attacks.
  • Have any medical or psychiatric condition that could interfere with the study.
  • Have had another cancer within the last 2 years, except for certain treated skin, breast, cervical, bladder, or prostate cancers.
  • Female participants who are pregnant or breastfeeding.

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