Moffitt logo

Clinical Trials Search

Clinical Trial 21421

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT04892173

Phase: Phase III
Principal Investigator: Caudell, Jimmy

Call 813-745-6100
or 1-800-679-0775 Learn More

Study Title

A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigators Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma


This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC


Primary: To evaluate survival outcomes in participants treated with intratumorally injected NBTXR3 activated by investigator s choice of RT alone or RT in combination with cetuximab in comparison to investigator s choice alone hereafter referred to as NBTXR3/RT+/- cetuximab versus RT+/-cetuximab. Secondary: To evaluate long-term survival outcomes of NBTXR3/RT +/-cetuximab versus R+/- cetuximab. To evaluate local-regional control of NBTXR3/RT +/- cetuximab versus RT +/-cetuximab. To evaluate distant control of NBTXR3/RT +/- cetuximab versus RT+/-cetuximab. To evaluate the antitumor response to NBTXR3/RT +/- cetuximab versus RT +/- cetuximab. To evaluate safety and tolerability of NBTXR3/RT +/- cetuximab versus RT+/-cetuximab. To assess patient-reported outcomes including symptoms, function, and health-related quality of life (QOL) in participants receiving NBTXR3/RT +/- cetuximab versus RT+/- cetuximab.



Immunotherapy; Radiotherapy


Cetuximab (); Erbitux (Cetuximab); NBTXR3 (); Not Applicable ()

Inclusion Criteria

  • Signed informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for the study, and is willing to participate in the study
  • Age >65 years
  • Biopsy-confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, supraglottic larynx, or hypopharynx (archived biopsies are allowed); if no biopsies are available, a new biopsy must be obtained to provide confirmation of SCC
  • For participants with oropharyngeal cancer, human papilloma virus (HPV) p16 status must be known
  • Tumor categories T3-T4 according to the 8th edition of the American Joint Committee on Cancer Staging Manual (AJCC v8)
  • Has at least 1 tumor lesion that can be accurately measured according to RECIST 1.1 (per the Central Imaging vendor) and is amenable for intratumoral injection, as determined by the Investigator
  • A single invaded, biopsy confirmed, accessible LN in the neck of >3 cm and > If a LN is selected for injection, 1 of the 2 injected lesions must be the primary tumor itself
  • Ineligible to receive platinum-based chemotherapy for the treatment of LA HNSCC as defined by having at least one of the following:
  • Estimated creatinine clearance >30 and 2 Grade >2 peripheral neuropathy ECOG >2 Recent cardiac dysfunction (history of unstable angina pectoris, myocardial infarction, or New York Heart Association (NYHA) class III chronic heart failure 6 months Adequate organ and bone marrow function at screening as defined by:

  • Exclusion Criteria

  • HNSCC category T1, T2 or M1 according to the 8th edition of the American Joint Committee on Cancer Staging Manual (AJCC v8)
  • Has received prior antineoplastic systemic therapy or intervention (including pharmacological - both marketed and investigational, RT, or surgery) for the treatment of HNSCC
  • Participants with known severe Grade 3 or 4 hypersensitivity reactions to cetuximab must be excluded from cetuximab treatment by the Investigator
  • Known history of human immunodeficiency virus (HIV), active hepatitis B, or active hepatitis C infection
  • Local regionally recurrent HNSCC
  • Ulceration or other characteristics that may, in the opinion of the Investigator, increase the risk of severe tumor bleeding
  • SCC originating in the nasopharynx or paranasal sinus, from the salivary gland, or thyroid gland, or non-squamous histology (e.g., melanoma or neuroendocrine carcinoma), or SCC of unknown primary origin
  • Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second- or third-degree atrioventricular heart block without a permanent pacemaker in place)
  • Class IV congestive heart failure as defined by the New York Heart Association functional classification system > A pregnant or nursing woman, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception starting from signed ICF through 150 days after the last cetuximab dose/RT fraction. > A woman who is 2 years postmenopausal or surgically sterile is not considered to be of childbearing potential.
  • A known history of areca nut (betel nut) consumption
  • Any condition for that, in the opinion of the Investigator, participation would not be in the best interest of the individual (e.g., compromises the participant's well-being) or that could prevent, limit, or confound the protocol/CIP specified assessments
  • Subject participating in another clinical study at the time of signature of the informed consent form

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.