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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

ConditionsMetastatic Head-and-neck Squamous-cell CarcinomaRecurrent Head and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAVEO Pharmaceuticals, Inc.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female and ≥ 18 years of age

Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC

Participants with oropharyngeal cancer will be required to have proof of p16 negative status submitted on the basis of a pathology report

At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented

Disqualifiers

Participants who have received > 2 prior lines of anticancer therapy or prior treatment with cetuximab/alternative EGFR inhibitors for the treatment of R/M HNSCC

History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab

Known or suspected untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis Note: Participants with locally treated brain metastases are eligible provided 2 weeks have elapsed since local therapy. Participants are allowed to continue steroid taper during the start of study treatment.

2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ficlatuzumab

    Biological/Vaccine

    Ficlatuzumab (AV-299) is a humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G1 (IgG1) monoclonal antibody (mAb).

  • Cetuximab

    Biological/Vaccine

    Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.

  • Placebo

    Other intervention

    Placebo for this study will be normal saline

Treatment groups

410 Participants
are divided into 3 treatment groups
Group A: Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab)Experimental treatment 2 interventions
Group B: Arm 2 (Investigational Arm: ficlatuzumab plus cetuximab)Experimental treatment 2 interventions
Group C: Arm 3 (Comparator Arm: placebo plus cetuximab)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)

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

Time frame
From Randomization until death from any cause (Approximately 44 months)

Secondary outcomes

1

To evaluate progression-free survival (PFS) for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

Progression-free survival (PFS), defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first

Time frame
From Randomization until disease progression or death (Approximately 44 months)
2

To evaluate additional objective response rate for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

Objective response rate (ORR), defined as the percentage of participants who have a complete response (CR) or a partial response (PR) per RECIST v1.1

Time frame
From Cycle 1 Day 1 until last response assessment (response assessments are every 8 weeks for the first year, every 12 weeks for years 2 and 3 and then every 6 months)
3

To evaluate disease control rate (DCR) for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

Disease control rate (DCR), defined for participants who have achieved a CR, PR or stable disease for at least 8 weeks per RECIST v1.1

Time frame
From Cycle 1 Day 1 until last response assessment (response assessments are every 8 weeks for the first year, every 12 weeks for years 2 and 3 and then every 6 months)
4

To evaluate duration of response (DOR) for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

Duration of response (DOR), defined as the time from first documented evidence of a confirmed CR or PR per RECIST v1.1

Time frame
From Cycle 1 Day 1 until last response assessment (response assessments are every 8 weeks for the first year, every 12 weeks for years 2 and 3 and then every 6 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AVEO Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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