Locally Advanced Head & Neck Squamous Cell Carcinoma MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Erbitux, 5 mg/mL, 20 mL vials
Product Name: Cetuximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923-56-4
Concentration unit: mg/ml milligram(
Sponsors
Nanobiotix SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form (ICF) indicating that the subject understands the purpose of, andprocedures required for the study, and is willing to participate in the study 2. Age =60 years 3. Biopsy-confirmed SCC of the oral cavity, oropharynx, hypopharynx or supraglottic larynx (archived biopsies are allowed); if no biopsies are available, a new biopsy must be obtained to provideconfirmation of SCC 4. For subjects with oropharyngeal cancer, HPV status must be known 5. Tumor categories T3-T4 any N or T2, if =N2 according to the 8th edition of the AJCC Cancer Staging Manual 6. Has one primary tumor lesion that is amenable for intratumoral injection, as determined by the Investigator 7. Ineligible to receive platinum-based chemotherapy for the treatment of LA HNSCC as defined by having at least 1 of the following: a. Estimated creatinine clearance =30 and 9.0 g/dL b. Platelet count =100,000 cells/mm3 c. Leukocytes >3000 cells/mm3 d. Absolute neutrophil count >1500 cells/mm3 e. Alanine aminotransferase (ALT) =3×upper limit of normal (ULN) f. Aspartate aminotransferase (AST) =3×ULN g. Total bilirubin =1.5 ULN (in subjects with Gilbert's syndrome, if total bilirubin is >1.5×ULN,measure direct and indirect bilirubin and if direct bilirubin is =1.5×ULN, the subject may be eligible) h. Total serum magnesium within normal ranges if the subject is a candidate for cetuximab treatment as per the Investigator's choice prior to randomization. i. Estimated creatinine clearance =30 mL/min (calculated by Cockcroft and Gault) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 470
Exclusion criteria
Exclusion criteria: 1. HNSCC category T1, T2N0, T2N1, or M1 according to the 8th Edition of AJCC Cancer Staging Manual 2. Has received prior antineoplastic systemic therapy or intervention (including pharmacological - both marketed and investigational, RT, or surgery) for the treatment of HNSCC 3. Subjects with known severe Grade 3 or 4 hypersensitivity reactions to cetuximab and subjects with known prior or ongoing interstitial lung disease must be excluded as a candidate for cetuximab treatment as per the Investigator's choice before randomization (these subjects can still be eligible for the study, only if RT alone or NBTXR3+RT alone is chosen and documented from cetuximab treatment by the Investigator before randomization) 4. Known history of HIV, chronically ongoing active hepatitis B, or chronically ongoing active hepatitis C infection as defined in AASLD/EASL guidelines 5. Loco-regionally recurrent HNSCC that has been previously treated with surgery, chemotherapy and/ or RT are not eligible for the study. 6. Ulceration or other characteristics (e.g. bleeding diathesis) that may, in the opinion of the Investigator, increase the risk of severe tumor bleeding 7. SCC originating in the nasopharynx or paranasal sinus, from the salivary gland, or thyroid gland, or on-squamous histology (e.g., melanoma or neuroendocrine carcinoma), or SCC of unknown primary origin 8. Prior or concurrent malignancy (including a second synchronous HNSCC) whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen except when: - The risk of the prior malignancy interfering with either safety or efficacy endpoints is very low; and if all treatment of that malignancy was completed at least 2 years before randomization and the subject has no clinical evidence of disease recurrence. This exception includes completely resected/treated non-melanoma skin cancer, cervical uterine cancer, T1N0M0 invasive hormone sensitive breast cancer, hormone sensitive prostate cancer with a Gleason score of 6, and completely resected non muscle invasive bladder cancer. 9. 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) 10. Class IV congestive heart failure as defined by the NYHA functional classification system 1 year postmenopausal or who is surgically sterile is not considered to be of childbearing potential (pregnancy test is not required). 12. 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 subject's well-being) or that could prevent, limit, or confound the protocol/CIP specified assessments, including subjects under legal protection. 13. Ongoing or active bacterial or fungal infection (includes infection requiring treatment with antimicrobial therapy for which participants will be required to complete 2 weeks before randomization), symptomatic viral infection, any other clinically significant infec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate survival outcomes in subjects 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 Objective: To evaluate long-term survival outcomes of NBTXR3/RT±cetuximab versus RT±cetuximab;Primary end point(s): PFS: time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first;Timepoint(s) of evaluation of this end point: ITT population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): OS: time from randomization to death from any cause;Timepoint(s) of evaluation of this end point: ITT population. | — |
Countries
Austria, Belgium, Brazil, Canada, China, Czechia, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Philippines, Portugal, Romania, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactNANORAY-312 CST
Nanobiotix SA
Outcome results
None listed