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Clinical Trial 19647

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT03422536

Phase: Phase II
Prinicipal Investigator: Christine Chung

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Study Title

A Randomized, Phase II Study of Ficlatuzumab with or without Cetuximab in Patients with Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma


This randomized phase II trial studies how well ficlatuzumab with or without cetuximab work 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 Objective: To assess the efficacy of ficlatuzumab, with or without concurrent cetuximab, in patients with cetuximab-resistant, recurrent/metastatic HNSCC as measured by Progression-Free Survival (PFS). Secondary Objective: To describe toxicity and patient-reported quality of life. - To evaluate response rate and overall survival in both treatment arms. - To evaluate the relationship between clinical outcomes (PFS, RR) and candidate tumoral, genomic, peripheral, and immune biomarkers, including: HGF/cMet, EGFR/EGFR, and EGFR/HER2 dimers; mutations in PIK3CA, PTEN, and HRAS; peripheral serum biomarkers including VeriStrat, HGF, soluble HGF, and IL6; peripheral lymphocyte populations; archived and baseline immune infiltrate.




Cetuximab (); Erbitux (Cetuximab); Ficlatuzumab ()

Inclusion Criteria

  • Patients must have histologically confirmed HNSCC from any primary site; except nasopharyngeal if WHO Type III. This includes: basaloid, poorly differentiated, and undifferentiated carcinoma histologies; nasopharyngeal carcinoma, World Health Organization (WHO) type I and II (keratinizing, non-Epstein-Barr virus [EBV] positive), will be included; paranasal sinus, lip and external auditory canal sites; squamous cell carcinoma of unknown primary, clearly related to the head and neck, will be included
  • Recurrent/metastatic disease.
  • For patients with oropharyngeal primary site or unknown primary site only: Patients must have known tumoral HPV status; 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 deoxyribonucleic acid (DNA)
  • Patients must be cetuximab-resistant.
  • Patients must be platinum-resistant or platinum-ineligible.
  • Prior exposure to immunotherapy, including anti-PD1/PDL1, anti-CTLA4, anti-tumor necrosis factor receptor (TNFR) antibodies or other investigational immunotherapies, is acceptable
  • Patients must have Eastern Cooperative Oncology Group performance status 0-1 at time of informed consent
  • Patients must consent to a research biopsy of tumor tissue at baseline, for conduct of correlative studies; archived biopsy material may only be substituted only if no interval anti-cancer systemic therapy has been administered
  • Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1, per scan within 28 days prior to registration
  • Adequate organ function
  • Note: Patients may be supplemented to achieve acceptable electrolyte values
  • No prior severe infusion reaction to cetuximab or a monoclonal antibody
  • Written informed consent must be obtained from all patients prior to beginning therapy; patients should have the ability to understand and the willingness to sign a written informed consent document
  • Documentation of negative pregnancy test within 14 days prior to registration for women of childbearing potential; a negative pregnancy test must also be confirmed within 3 days of the first dose of ficlatuzumab; sexually active women of childbearing potential must agree to use adequate contraceptive measures, while on study and for 60 days after the last dose of study drug;

  • Exclusion Criteria

  • 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 hepatocyte growth factor (HGF)/cMet inhibitor such as rilotumumab, crizotinib, MetMAb, or ARQ197
  • Uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases, are not allowed; 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 => Significant pulmonary disease, including pulmonary hypertension or interstitial pneumonitis
  • Significant cardiovascular disease
  • Significant thrombotic or embolic events within 4 weeks prior to study day 1
  • Any other medical condition (e.g, alcohol abuse) or psychiatric condition that, in the opinion of the investigator, might interfere with the subjects participation in the trial or interfere with the interpretation of trial results
  • History of second malignancy within 2 years prior to study day 1. Some exceptions may apply.
  • Major surgery within 6 weeks prior to study day 1 (subjects must have completely recovered from any previous surgery prior to study day 1)
  • Active infection requiring systemic antibiotics or antifungals within 7 days prior to first dose of study drug; exception: tetracycline family antibiotics (tetracycline, doxycycline, minocycline) administered for the management of cetuximab-related rash may be continued per the investigators judgment
  • Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated; Note: HIV testing is not required for entry into this protocol
  • Women must not be pregnant or breastfeeding; pregnant women are excluded from this study

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