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Official Title
A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-HN)
Phase
Phase 3
Sponsor
AVEO Pharmaceuticals, Inc.
Enrollment
410
Timeline
Jan 2024 → Nov 2027
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.
Eligibility Criteria
Inclusion Criteria
- 1Male or female and ≥ 18 years of age
- 2Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC
- 3Participants with oropharyngeal cancer will be required to have proof of p16 negative status submitted on the basis of a pathology report
- 4At 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
- 5Participants 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
- 6Patient's tumor must be considered inoperable and incurable
- 7Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of at least 12 weeks
- 8For women of childbearing potential (WOCBP), documentation of negative serum pregnancy test within 30 days of randomization
- 9For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 5 months after the last dose of study treatment. Birth control methods which may be considered highly effective include methods that achieve a failure rate of less than 1% per year when used consistently and correctly.
- 10Ability to give written informed consent and comply with protocol requirements
- 11Patients with feeding tubes are eligible for the study.
- 12Archived tissue sample must be submitted to the Sponsor-designated laboratory within 60 days of randomization for c-Met analysis (if a tissue sample is not available, a fresh biopsy may be required prior to enrollment)
Exclusion Criteria
- 1Participants who have received \> 2 prior lines of anticancer therapy or prior treatment with cetuximab/alternative EGFR inhibitors for the treatment of R/M HNSCC
- 2History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab
- 3Known 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.
- 4Prior treatment with any other investigational drug or biologic agent or radiation therapy before a washout has been completed (must be completed prior to randomization):
- 52 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors
- 63 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates
- 74 weeks (28 days) for cell therapies
- 82 weeks (14 days) for radiation therapy
- 9Any unresolved and significant toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) Grade \> 2 from previous anticancer therapy (including radiation therapy), other than alopecia
- 10Significant cardiovascular disease, including: Cardiac failure New York Heart Association class III or IV; Myocardial infarction, severe or unstable angina within 6 months prior to randomization; History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
- 11Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the participant's involvement in the study or interfere with the interpretation of study results
- 12History of prior malignancy within 2 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early-stage prostate cancer, without evidence of recurrence; participants may or may not be on maintenance therapy)
- 13Participants who are positive for HBV or HCV with indication of acute or chronic hepatitis (as defined in protocol)
- 14Radiographic evidence (historical or at screening) of interstitial lung disease or idiopathic pulmonary fibrosis
- 15Female participants who are pregnant or breastfeeding
Locations
110 sites participating in this study
Emory University
Atlanta, Georgia 30308
Banner MD Anderson Cancer Center
Gilbert, Arizona 85212
The University of Arizona Cancer Center
Tucson, Arizona 85719
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →