Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma
A Randomized, Phase II Study of Ficlatuzumab With or Without Cetuximab in Patients With Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
4 other identifiers
interventional
78
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2017
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2017
CompletedFirst Submitted
Initial submission to the registry
January 19, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2022
CompletedResults Posted
Study results publicly available
July 19, 2023
CompletedSeptember 4, 2024
August 1, 2024
4.3 years
January 19, 2018
April 6, 2023
August 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Will be estimated for each arm using a Kaplan-Meier curve.
From the date of randomization until the date of progression or death, assessed up to 2 years
Secondary Outcomes (3)
Percentage of Participants With Dose Limiting Toxicities or Adverse Events
Up to 2 years
Overall Survival (OS)
From the date of randomization until the date of death, assessed up to 2 years
Overall Response Rate (ORR)
Up to 2 years
Other Outcomes (5)
Change in Quality of Life
Pre-study (within 4 weeks of study registration) and Week 4, Cycle 2 of Intervention
Tumor Biomarker Analysis
Up to 2 years
Genomic Biomarker Analysis
Up to 2 years
- +2 more other outcomes
Study Arms (2)
Arm I (ficlatuzumab)
EXPERIMENTALPatients 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.
Arm II (ficlatuzumab, cetuximab)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- \- Patients must have histologically confirmed HNSCC from any primary site, except nasopharyngeal if World Health Organization (WHO) Type III (non-keratinizing and Epstein-Barr virus (EBV)-positive)).
- Eligible histologies include:
- Basaloid, poorly differentiated, and undifferentiated carcinoma histologies.
- Nasopharyngeal carcinoma, WHO Type I and II (keratinizing, non-EBV positive).
- Paranasal sinus, lip and external auditory canal sites.
- Squamous cell carcinoma of unknown primary, clearly related to the head and neck.
- Note: Documentation of primary site diagnosis must be submitted with the registration request.
- Patients must have recurrent and/or metastatic disease, fulfilling at least one of the criteria defined below:
- Incurable disease as assessed by surgical or radiation oncology;
- Metastatic (M1) disease;
- Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity. Note: Patients who decline radical surgery are eligible.
- For patients with oropharyngeal primary site or unknown primary site only: Patients must have known tumoral HPV status (p16). (Acceptable standards include p16 immunohistochemistry (where a tumor is classified as p16-positive when showing diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells) and/or assessment of HPV DNA.) Note: For these subjects, documentation of p16 status must be submitted with the registration packet.
- Patients must be cetuximab-resistant by fulfilling at least one of the two criteria defined below:
- Disease persistence or recurrence within 6 months of completing definitive radiotherapy with concurrent cetuximab for locally advanced disease. Induction chemotherapy, if given, may or may not have included cetuximab.
- Disease progression during, or within 6 months, of cetuximab treatment in the recurrent and/or metastatic setting.
- +28 more criteria
You may not qualify if:
- Nasopharyngeal primary site if WHO Type III (non-keratinizing and EBV-positive as established at the local site).
- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent.
- Prior treatment with an HGF/cMet inhibitor such as rilotumumab, crizotinib, MetMAb, or tivantinib (ARQ197).
- Uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases, are not allowed.
- Note: Subjects with previously treated brain metastases will be allowed if the brain metastases have been stable without steroid treatment for at least 2 weeks (radiotherapy or surgery).
- Failure to recover to Grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy, with the exception of:
- Alopecia,
- Grade ≤ 2 peripheral neuropathy,
- Grade ≤ 2 cetuximab-related rash or other skin changes,
- Treatment with cetuximab 2 weeks prior to the first dose of study drug. A washout period of 2 weeks from prior cetuximab is required if applicable.
- Treatment with cytotoxic chemotherapy, targeted therapy, immunotherapy or investigational drug 3 weeks prior to the first dose of study drug. A washout period of 3 weeks from any prior cytotoxic chemotherapy, targeted therapy, immunotherapy or investigational drug is required, if applicable.
- Significant underlying pulmonary disease, including pulmonary hypertension or interstitial pneumonitis.
- Peripheral edema ≥ Grade 2 per NCI-CTCAE version 4.0.
- Significant cardiovascular disease, including:
- Cardiac failure New York Heart Association (NYHA) class III or IV.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- National Cancer Institute (NCI)collaborator
Study Sites (6)
The University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (1)
Bauman JE, Saba NF, Roe D, Bauman JR, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Klein R, Saboda K, Obara S, Chung CH. Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer. J Clin Oncol. 2023 Aug 1;41(22):3851-3862. doi: 10.1200/JCO.22.01994. Epub 2023 Mar 28.
PMID: 36977289DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rachel Jarrett
- Organization
- University of Arizona Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Julie E. Bauman, MD, MPH
The University of Arizona
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2018
First Posted
February 5, 2018
Study Start
December 5, 2017
Primary Completion
March 29, 2022
Study Completion
April 5, 2022
Last Updated
September 4, 2024
Results First Posted
July 19, 2023
Record last verified: 2024-08