BTXR3 With or Without Cetuximab in Locally Advanced Head & Neck Squamous Cell Carcinoma (LA-HNSCC)
- Conditions
- Health Condition 1: C760- Malignant neoplasm of head, face and neck
- Registration Number
- CTRI/2022/12/048448
- Lead Sponsor
- anobiotix SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
2) 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
3) For subjects with oropharyngeal cancer, HPV status must be known
4) Tumor categories T3-T4 according to the 8th edition of the American Joint Committee on Cancer Staging Manual (AJCC v8)
5) 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 <10 cm and with <180-degree encasement of the carotid artery on MRI or CT scan is eligible for intranodal injection
If a LN is selected for injection, 1 of the 2 injected lesions must be the primary tumor itself.
6) 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 <50 mL/min (calculated by Cockcroft and Gault)
b) Hearing loss or tinnitus Grade >=2
c) Grade >=2 peripheral neuropathy
d) ECOG >2
e) Recent cardiac dysfunction (history of unstable angina pectoris, myocardial infarction, or New York Heart Association (NYHA) Class III chronic heart failure <3 years prior to screening)
7) Must be able to tolerate RT with curative intent as determined by the study Investigator
8) Amenable to definitive treatment with RT. For subjects with an oral cavity cancer, the decision for definitive treatment with RT requires consultation with the head and neck surgeon and the siteâ??s multidisciplinary tumor board
9) ECOG performance status of 0 to <=2
10) Life expectancy >=6 months
11) 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) ALT <=3 x upper limit of normal (ULN)
f) AST <=3 x ULN
g) Total bilirubin <=1.5 mg/dL (in subjects with Gilbertâ??s syndrome, if total bilirubin is >1.5Ã?ULN, measure direct and indirect bilirubin and if direct bilirubin is <=1.5Ã?ULN, the subject may be eligible)
h) Total serum magnesium within normal ranges (1.7-2.2 mg/dL or 0.85 to 1.10 mmol/L)
Screening laboratory assessments will be performed by a central laboratory.
1) HNSCC category T1, T2, or M1 according to AJCC v8
2) Has received prior antineoplastic systemic therapy or intervention (including pharmacological â?? 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 must be excluded from cetuximab treatment by the Investigator
4) Known history of HIV, active hepatitis B, or active hepatitis C infection
5) Local regionally recurrent HNSCC
6) Ulceration or other characteristics that may, in the opinion of the Investigator, increase the risk of severe tumor bleeding
7) SCC originating in the nasopharynx or paranasal sinus, salivary gland, or thyroid gland, or non-squamous histology (e.g., melanoma or neuroendocrine carcinoma), or SCC of unknown primary origin
8) Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
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 <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 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
12) A known history of areca nut (betel nut) consumption for 10 years or more
13) Any condition that, in the opinion of the Investigator, participation would not be in the best interest of the individual (e.g., compromises the subjectâ??s well-being) or that could prevent, limit, or confound the protocol/CIP-specified assessments
14) Subject participating in another clinical study, except for a non-interventional trial/registry, at the time of signing the ICF
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS)Timepoint: time from randomization to <br/ ><br>local-regional recurrence, local-regional <br/ ><br>progression, distant progression, or death <br/ ><br>from any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method