Ficlatuzumab + Cetuximab for Head and Neck Cancer
(FIERCE-HN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, there is a 'washout period' (time without taking certain medications) required for prior treatments, which includes 2 weeks for chemotherapeutic agents and radiation therapy, and 3 weeks for antibody-drug conjugates.
What safety data exists for the treatment of Ficlatuzumab + Cetuximab in humans?
What makes the drug combination of Ficlatuzumab and Cetuximab unique for head and neck cancer?
The combination of Ficlatuzumab and Cetuximab is unique because it targets two pathways that are involved in cancer growth, potentially overcoming resistance to Cetuximab alone. Ficlatuzumab blocks the HGF/cMet pathway, while Cetuximab targets the EGFR pathway, making this combination promising for patients with cetuximab-resistant head and neck cancer.16789
What data supports the effectiveness of the drug combination Ficlatuzumab and Cetuximab for head and neck cancer?
Research shows that Cetuximab, when used with radiotherapy, improves outcomes for patients with advanced head and neck cancer without increasing side effects. Additionally, Cetuximab has been effective in treating other cancers, like colorectal cancer, by targeting specific cancer cell receptors.19101112
Are You a Good Fit for This Trial?
This trial is for adults over 18 with recurrent or metastatic HPV-negative head and neck squamous cell carcinoma who've had prior unsuccessful treatment with anti-PD-1/PD-L1 therapy and platinum-based chemo. They should be reasonably healthy (ECOG status of 0 or 1) and not pregnant, willing to use contraception, and have a measurable lesion that hasn't been treated by radiation unless it's clearly growing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ficlatuzumab or placebo in combination with cetuximab every 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cetuximab
- Ficlatuzumab
Cetuximab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
AVEO Pharmaceuticals, Inc.
Lead Sponsor