Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06064877
Registration number
NCT06064877
Ethics application status
Date submitted
14/09/2023
Date registered
3/10/2023
Date last updated
4/06/2024
Titles & IDs
Public title
A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma
Query!
Scientific 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)
Query!
Secondary ID [1]
0
0
AV-299-23-301
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
FIERCE-HN
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Head-and-neck Squamous-cell Carcinoma
0
0
Query!
Recurrent Head and Neck Squamous Cell Carcinoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Cancer
0
0
0
0
Query!
Head and neck
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - Ficlatuzumab
Other interventions - Cetuximab
Other interventions - Placebo
Experimental: Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab) - Intravenous (IV) ficlatuzumab dose A on Day 1 (D1) and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle
Experimental: Arm 2 (Investigational Arm: ficlatuzumab plus cetuximab) - IV ficlatuzumab dose B on D1 and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle
Placebo Comparator: Arm 3 (Comparator Arm: placebo plus cetuximab) - IV placebo (saline, ficlatuzumab-matched) on D1 and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle
Other interventions: Ficlatuzumab
Ficlatuzumab (AV-299) is a humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G1 (IgG1) monoclonal antibody (mAb).
Other interventions: Cetuximab
Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.
Other interventions: Placebo
Placebo for this study will be normal saline
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
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)
Query!
Assessment method [1]
0
0
Overall survival (OS), defined as the time from the date of randomization to the date of death for any cause
Query!
Timepoint [1]
0
0
From Randomization until death from any cause (Approximately 44 months)
Query!
Secondary outcome [1]
0
0
To evaluate additional endpoints of efficacy for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
From Randomization until disease progression or death (Approximately 44 months)
Query!
Secondary outcome [2]
0
0
To evaluate additional endpoints of efficacy for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Query!
Assessment method [2]
0
0
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
Query!
Timepoint [2]
0
0
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)
Query!
Secondary outcome [3]
0
0
To evaluate additional endpoints of efficacy for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Query!
Assessment method [3]
0
0
Duration of response (DOR), defined as the time from first documented evidence of a confirmed CR or PR per RECIST v1.1
Query!
Timepoint [3]
0
0
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)
Query!
Secondary outcome [4]
0
0
To compare the safety and tolerability of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Query!
Assessment method [4]
0
0
Number of times participants experience Adverse Events (AE) or abnormal laboratory values.
Query!
Timepoint [4]
0
0
From Screening until 30 days after last dose
Query!
Secondary outcome [5]
0
0
To evaluate the pharmacokinetics (Pk) of ficlatuzumab and cetuximab
Query!
Assessment method [5]
0
0
Serum samples will be assessed for concentrations of ficlatuzumab and cetuximab
Query!
Timepoint [5]
0
0
From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
Query!
Secondary outcome [6]
0
0
To assess the immunogenicity of ficlatuzumab via antidrug antibodies (ADAs)
Query!
Assessment method [6]
0
0
Serum samples will be assessed for the presence of ADA to ficlatuzumab.
Query!
Timepoint [6]
0
0
From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
Query!
Secondary outcome [7]
0
0
To assess the immunogenicity of ficlatuzumab via neutralizing antibodies (nAB)
Query!
Assessment method [7]
0
0
Serum samples that test positive for the presence of ADA to ficlatuzumab will be further tested for the presence of nAB.
Query!
Timepoint [7]
0
0
From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
Query!
Eligibility
Key inclusion criteria
- 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 HPV-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
- 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
- For 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 60 days 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.
- Ability to give written informed consent and comply with protocol requirements
- Patients with feeding tubes are eligible for the study.
- Archived tissue sample must be submitted to the Sponsor-designated laboratory within
60 days of randomization for c-Met/HGF analysis
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- History of severe allergic or anaphylactic reactions or hypersensitivity to
recombinant proteins or excipients in the investigational agent or cetuximab
- Known 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 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
- Any 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
- Significant 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)
- Any 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
- History 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)
- Female participants who are pregnant or breastfeeding
A full list of inclusion and exclusion criteria can be found in the protocol.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/01/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/11/2027
Query!
Actual
Query!
Sample size
Target
410
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Query!
Recruitment hospital [1]
0
0
St George Hospital - Kogarah
Query!
Recruitment hospital [2]
0
0
St. Vincent's Hospital - Sydney
Query!
Recruitment hospital [3]
0
0
Princess Alexandra Hospital - Brisbane
Query!
Recruitment hospital [4]
0
0
St. John of God Murdoch Hospital - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
4102 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Wisconsin
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Ontario
Query!
Country [15]
0
0
United Kingdom
Query!
State/province [15]
0
0
Aberdeen
Query!
Country [16]
0
0
United Kingdom
Query!
State/province [16]
0
0
London
Query!
Country [17]
0
0
United Kingdom
Query!
State/province [17]
0
0
Nottingham
Query!
Country [18]
0
0
United Kingdom
Query!
State/province [18]
0
0
Sutton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AVEO Pharmaceuticals, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06064877
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Clinical Trials Office
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+1.857.400.0101
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06064877
Download to PDF