A Phase 2 interventional study of Cetuximab and Ficlatuzumab in Head and Neck Basaloid Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Oropharyngeal Squamous Cell Carcinoma, sponsored by University of Arizona. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by University of Arizona · Phase 2, Interventional, and Treatment
Among 1,098 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States — 217 open to participants now, 346 under way, 28 of them phase 3. Squamous Cell Carcinoma of Head and Neck · United States.
Among the 1,098 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States, this one is the 304th largest by enrollment of the 992 interventional ones, is one of 49 that started in 2017, is one of 359 in phase 2, and was the 519th registered.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's enrollment of 78 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →217 of the 1,098 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 434 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 310 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,098 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 49 started in 2017.
Median enrollment 41 across the 992 interventional studies, 130 across the 63 observational. Of the 690 that completed or were terminated, 288 (42%) have results posted.
420 of 1,098 have an industry lead sponsor. The 10 most frequent:
University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
University of Arizona has 4 studies filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
108 of the studies in Squamous Cell Carcinoma of Head and Neck with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06998069Phase 3Brown UniversityHead and Neck Cancer Study Project in the Geriatric Population | 2026-12-01 |
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT04965792Dana-Farber Cancer InstitutePost-treatment Surveillance in HPV+ Oropharyngeal SCC | 2026-11 |
| NCT05600842University of California, IrvineDe-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx | 2026-11 |
| NCT05681039M.D. Anderson Cancer CenterPhase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma (OCSCC). | 2026-11-01 |
Among the 1,098 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States, from their registry updates:
This randomized phase II trial studies how well ficlatuzumab with or without cetuximab works in treating patients with head and neck squamous cell carcinoma that has come back or spread to other places in the body and resistant to cetuximab treatment. Monoclonal antibodies, such as ficlatuzumab and cetuximab, may block growth signals that lets a tumor cell survive and reproduce, and helps the immune system recognize and fight head and neck squamous cell carcinoma.
PRIMARY OBJECTIVES:
I. To assess the efficacy of ficlatuzumab, with or without concurrent cetuximab, in patients with cetuximab-resistant, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) as measured by progression-free survival (PFS).
SECONDARY OBJECTIVES:
I. To describe toxicity. II. To evaluate response rate and overall survival in both treatment arms.
EXPLORATORY OBJECTIVES I. To describe patient reported quality of life
II. To evaluate the relationship between clinical outcomes (Progression-Free Survival and Response Rate) and candidate tumoral, genomic, peripheral, and immune biomarkers, potentially including but not limited to:
OUTLINE: Patients are randomized into 1 of 2 arms.
Arm I: Patients receive ficlatuzumab intravenously (IV) over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligible histologies include:
Note: Documentation of primary site diagnosis must be submitted with the registration request.
Note: Prior cetuximab exposure may have occurred in any (first line, second line, etc.) and is not required to be the most recent therapy received.
Note: Prior platinum exposure may have occurred in any line of therapy (first line, second line, etc.) and is not required to be the most recent therapy received.
Note: Prior exposure to immunotherapies, including anti-CTLA4 (cytotoxic T-lymphocyte-associated antigen 4), anti-OX40, anti-0 (cluster of differentiation 40), anti-CD27, anti-TNFR (tumor necrosis factor receptor) antibodies or other investigational immunotherapies, is acceptable.
Calculated Creatinine Clearance = [(140-age) X (actual body weight in kg) X (0.85 if female)]/(72 X serum creatinine)
* Total ≤ 1.5 times upper-limit of normal ()
Exclusion Criteria
Note: Subjects with previously treated will be allowed if the brain metastases have been stable without treatment for at least 2 weeks (radiotherapy or surgery).
pT1a /pT1b prostate cancer comprising \< 5% of resected tissue with normal prostate specific antigen (PSA) since resection, or
* cT1a/cT1b prostate cancer treated with brachytherapy or external beam radiation therapy with normal PSA since radiation.
Note: Active topical infections (for example oral thrush) do not exclude a subject even if treated with systemic antibiotics or systemic antifungals.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Ficlatuzumab
Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Biological: Cetuximab · Drug: Ficlatuzumab
Given IV
Also known as: Chimeric Anti-EGFR Monoclonal Antibody, Chimeric MoAb C225, Chimeric Monoclonal Antibody C225, Erbitux, IMC-C225
Given IV
Also known as: Anti-HGF Monoclonal Antibody SCH900105, AV-299, SCH 900105
Progression Free Survival (PFS)
Will be estimated for each arm using a Kaplan-Meier curve.
Time frame: From the date of randomization until the date of progression or death, assessed up to 2 years
Percentage of Participants With Dose Limiting Toxicities or Adverse Events
The percentage of participants with dose limiting toxicities in each dosing cohort will be reported, as will the percentage of participants with adverse events in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events version 4 grading criteria. Will be tabulated and reported with 95% exact confidence intervals.
Time frame: Up to 2 years
Overall Survival (OS)
Will be estimated for each arm using a Kaplan-Meier curve.
Time frame: From the date of randomization until the date of death, assessed up to 2 years
Overall Response Rate (ORR)
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1) for target lesions and assessed by CT/MRI w/ contrast: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), the regression of all Target lesions (the sum) by 30% with no progression of Non-targets or presence of new lesion; Overall Response (OR) = CR + PR. Will be tabulated and reported with 95% exact confidence intervals.
Time frame: Up to 2 years
Change in Quality of Life
Will be assessed by Foundation for the Accreditation of Cellular Therapy Head and Neck Questionnaire.
Time frame: Pre-study (within 4 weeks of study registration) and Week 4, Cycle 2 of Intervention
Tumor Biomarker Analysis
Will evaluate the relationship between clinical outcomes (progression free survival, response rate) and candidate tumoral biomarkers: Tumor HGF and cMET expression. The relationship with clinical response will be assessed.
Time frame: Up to 2 years
Genomic Biomarker Analysis
To evaluate the relationship between clinical outcomes (Progression-Free Survival and Response Rate) and candidate genomic biomarkers: mutations in PIK3CA, PTEN, and HRAS
Time frame: Up to 2 years
Peripheral Biomarker Analysis
Will evaluate the relationship between clinical outcomes (progression free survival, response rate) and candidate peripheral biomarkers: peripheral serum biomarkers including HGF, soluble HGF, and IL6; peripheral lymphocyte populations. The relationship with clinical response will be assessed.
Time frame: Up to 2 years
Immune Biomarker Analysis
Will evaluate the relationship between clinical outcomes (progression free survival, response rate) and candidate immune biomarkers: archived and baseline immune filtrate; tumor HPV status. The relationship with clinical response will be assessed.
Time frame: Up to 2 years
This multicenter study was conducted at the University of Arizona, Emory University, Fox Chase Cancer Center, Medical University of South Carolina, Yale Cancer Center, and Moffitt Cancer Center. The study opened to accrual on 12/05/2017 and closed to accrual on 12/05/2020. Potential patients were identified in the cancer center clinic by study investigators or referred. Weekly tumor board meetings are held at each institution where patients are discussed and referred to clinical trials.
| Milestone | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) |
|---|---|---|
| Started | 27 | 33 |
| Completed | 26 | 32 |
| Not completed | 1 | 1 |
| Withdrew: Physician decision | 1 | 1 |
| Milestone | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) |
|---|---|---|
| Started | 26 | 32 |
| Completed | 0 | 1 |
| Not completed | 26 | 31 |
| Withdrew: Disease progression | 19 | 25 |
| Withdrew: Death | 1 | 3 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
Will be estimated for each arm using a Kaplan-Meier curve.
| months | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) |
|---|---|---|
| Progression Free Survival (PFS) | 1.8 (1.7 to NA) | 3.7 (2.3 to NA) |
The percentage of participants with dose limiting toxicities in each dosing cohort will be reported, as will the percentage of participants with adverse events in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events version 4 grading criteria. Will be tabulated and reported with 95% exact confidence intervals.
| percentage of participants | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) |
|---|---|---|
| hypoalbuminemia | 66 | 76 |
| Edema | 25 | 44 |
| Acneiform rash | 12 | 82 |
| Pneumonitis | 8 | 3 |
Will be estimated for each arm using a Kaplan-Meier curve.
| months | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) |
|---|---|---|
| Overall Survival (OS) | 6.4 (3.0 to NA) | 7.4 (4.7 to NA) |
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1) for target lesions and assessed by CT/MRI w/ contrast: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), the regression of all Target lesions (the sum) by 30% with no progression of Non-targets or presence of new lesion; Overall Response (OR) = CR + PR. Will be tabulated and reported with 95% exact confidence intervals.
| Participants | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) |
|---|---|---|
| Overall Response Rate (ORR) | 1 | 6 |
Will be assessed by Foundation for the Accreditation of Cellular Therapy Head and Neck Questionnaire.
Results for this outcome have not been posted.
Will evaluate the relationship between clinical outcomes (progression free survival, response rate) and candidate tumoral biomarkers: Tumor HGF and cMET expression. The relationship with clinical response will be assessed.
| Participants | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) |
|---|---|---|
| HPV-negative patients | — | 13 |
| HPV-positive patients | — | 13 |
| HGF - HPV-positive | — | 13 |
| HGF - HPV-negative | — | 13 |
| C-met positive in HPV-negative patients | — | 9 |
| C-met positive in HPV-positive patients | — | 2 |
To evaluate the relationship between clinical outcomes (Progression-Free Survival and Response Rate) and candidate genomic biomarkers: mutations in PIK3CA, PTEN, and HRAS
Results for this outcome have not been posted.
Will evaluate the relationship between clinical outcomes (progression free survival, response rate) and candidate peripheral biomarkers: peripheral serum biomarkers including HGF, soluble HGF, and IL6; peripheral lymphocyte populations. The relationship with clinical response will be assessed.
Results for this outcome have not been posted.
Will evaluate the relationship between clinical outcomes (progression free survival, response rate) and candidate immune biomarkers: archived and baseline immune filtrate; tumor HPV status. The relationship with clinical response will be assessed.
Results for this outcome have not been posted.
Collected over Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Ficlatuzumab) | 1/26 (3.8%) | 7/26 (26.9%) | 24/26 (92.3%) |
| Arm II (Ficlatuzumab, Cetuximab) | 3/32 (9.4%) | 18/32 (56.3%) | 31/32 (96.9%) |
| Event | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) |
|---|---|---|
| Lung infectionInfections and infestations | 0/26 | 4/32 |
| BacteremiaInfections and infestations | 0/26 | 3/32 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 2/26 | 0/32 |
| Thromboembolic eventVascular disorders | 1/26 | 2/32 |
| Skin and soft tissue infectionInfections and infestations | 0/26 | 2/32 |
| FallInjury, poisoning and procedural complications | 0/26 | 2/32 |
| DysphagiaGastrointestinal disorders | 0/26 | 2/32 |
| Abdominal painGastrointestinal disorders | 0/26 | 2/32 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/26 | 2/32 |
| Pharyngeal HemorrhageRespiratory, thoracic and mediastinal disorders | 1/26 | 0/32 |
| Event | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) |
|---|---|---|
| Rash: acneiformSkin and subcutaneous tissue disorders | 2/26 | 26/32 |
| HypoalbumeniaMetabolism and nutrition disorders | 17/26 | 24/32 |
| Edema limbsGeneral disorders | 10/26 | 14/32 |
| DiarrheaGastrointestinal disorders | 1/26 | 7/32 |
| Facial EdemaGeneral disorders | 5/26 | 4/32 |
| Skin infectionInfections and infestations | 0/26 | 6/32 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/26 | 5/32 |
| FatigueGeneral disorders | 2/26 | 4/32 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/26 | 4/32 |
| HypokalemiaMetabolism and nutrition disorders | 0/26 | 4/32 |
| Age, Continuous(years) | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) | Total |
|---|---|---|---|
| Median | 65 (55 to 70) | 63 (59 to 71) | 63.5 (56.75 to 70.25) |
| Sex: Female, Male(Participants) | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) | Total |
|---|---|---|---|
| Female | 6 | 3 | 9 |
| Male | 21 | 30 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 23 | 29 | 52 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 24 | 30 | 54 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) | Total |
|---|---|---|---|
| United States | 27 | 33 | 60 |
| Primary Site(participants) | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) | Total |
|---|---|---|---|
| Oral Cavity | 8 | 6 | 14 |
| Oropharynx | 11 | 20 | 31 |
| Larynx | 3 | 4 | 7 |
| Nasopharynx | 2 | 1 | 3 |
| Paranasal sinus | 2 | 0 | 2 |
| External auditory canal | 0 | 1 | 1 |
| Unknown primary | 1 | 1 | 2 |
| HPV status(participants) | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) | Total |
|---|---|---|---|
| Positive | 11 | 17 | 28 |
| Negative | 16 | 16 | 32 |
| Median months since last cetuximab treatment(Months) | Arm I (Ficlatuzumab) | Arm II (Ficlatuzumab, Cetuximab) | Total |
|---|---|---|---|
| Median | 2.7 (0.9 to 13.1) | 3.6 (1.4 to 9.3) | 3.5 (1.1 to 9.7) |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Mar 2022, 51 months.
Results were first posted in Jul 2023, 1 year 3 months after primary completion.
Of 298 non-industry phase 2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 85. This study's 51 months is close to that.
Counting every sponsor, half of 366 studies reached it within 53 months; a quarter within 35 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ficlatuzumab
Squamous Cell Carcinoma of Head and Neck →