RecruitingMetastatic Head-and-neck Squamous-cell CarcinomaRecurrent Head and Neck Squamous Cell Carcinoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

20 states

Healthy volunteers

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About this study

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.

Sponsor: AVEO Pharmaceuticals, Inc.

You may qualify if…

✓ 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
✓ Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment
✓ Patient's tumor must be considered inoperable and incurable
✓ Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of at least 12 weeks
✓ For women of childbearing potential (WOCBP), documentation of negative serum pregnancy test within 30 days of randomization

You may not qualify if…

✕ 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.
✕ Prior treatment with any other investigational drug or biologic agent or radiation therapy before a washout has been completed (must be completed prior to randomization):
✕ 1. 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors
✕ 2. 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates
✕ 3. 4 weeks (28 days) for cell therapies
✕ 4. 2 weeks (14 days) for radiation therapy