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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

Overview

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

Summary

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

Objective

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.

Treatments

Therapies

Immunotherapy; Radiotherapy

Medications

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

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