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A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator’s 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
EU CTIS ID: 2024-513082-39-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Signed informed consent form (ICF) indicating that the subject understands the purpose of, and procedures required for the study, and is willing to participate in the study
- 10. ECOG performance status of 0 to ≤2
- 11. Life expectancy ≥6 months
- 12. Adequate organ and bone marrow function at screening as defined by: a. Hemoglobin >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)
- 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 provide confirmation of SCC
You likely can't join if
- 1. HNSCC category T1, T2 N0, T2 N1, or M1 according to the 8th Edition of AJCC Cancer Staging Manual.
- 10. Class IV congestive heart failure as defined by the NYHA functional classification system <6 months prior to screening
- 11. 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 the time that the ICF is signed through 150 days (18 months for South Korean subjects) after the last cetuximab dose/RT fraction. A woman who is ≥ 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 infection, or use of immune suppressive agents.
- 14. Subject participating in another clinical study, except for a non interventional trial/registry at the time of signing the ICF
See the full eligibility criteria
Who can join
- 1. Signed informed consent form (ICF) indicating that the subject understands the purpose of, and procedures required for the study, and is willing to participate in the study
- 10. ECOG performance status of 0 to ≤2
- 11. Life expectancy ≥6 months
- 12. Adequate organ and bone marrow function at screening as defined by: a. Hemoglobin >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)
- 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 provide confirmation 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 one of the following: a. Estimated creatinine clearance ≥30 and <50 mL/min (calculated by Cockcroft and Gault) b. Hearing loss or tinnitus Grade ≥2 c. Grade ≥2 peripheral neuropathy d. ECOG performance status=2 e. New York Heart Association (NYHA) Class III OR Aged 70-74 with Geriatric 8 (G8) score ≤14 or aged ≥75 years
- 8. Must be able to tolerate RT with curative intent as determined by the study Investigator.
- 9. Amenable to definitive treatment with RT. Subjects with an oral cavity cancer should not be eligible to the primary standard treatment, which is surgery, and the decision for definitive treatment with RT requires consultation with the head and neck surgeon, and the site's multidisciplinary tumor board.
What rules you out
- 1. HNSCC category T1, T2 N0, T2 N1, or M1 according to the 8th Edition of AJCC Cancer Staging Manual.
- 10. Class IV congestive heart failure as defined by the NYHA functional classification system <6 months prior to screening
- 11. 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 the time that the ICF is signed through 150 days (18 months for South Korean subjects) after the last cetuximab dose/RT fraction. A woman who is ≥ 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 infection, or use of immune suppressive agents.
- 14. Subject participating in another clinical study, except for a non interventional trial/registry at the time of signing the ICF
- 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 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.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, paranasal sinus, salivary gland, or thyroid gland; non-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, T1 N0 M0 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)
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Brazil
- Georgia
- Taiwan
- Philippines
- United Kingdom
- Israel
- United States
- Korea, Republic of
- Canada
- India
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Brazil; Georgia; Taiwan; Philippines; United Kingdom and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.