CTRI/2022/12/048448招募中3 期
A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigatorâ??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
anobiotix SA0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
研究者
相似试验
招募中
3 期
BTXR3 With or Without Cetuximab in LA-HNSCCocally Advanced Head and Neck Squamous Cell CarcinomaJPRN-jRCT2051220124Floris Andriessen20
进行中（未招募）
1 期
BTXR3 with or without cetuximab in Locally Advanced Head & Neck Squamous Cell Carcinoma (LA-HNSCC)ocally Advanced Head & Neck Squamous Cell CarcinomaMedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-002163-22-DEanobiotix SA500
招募中
3 期
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCCLocally Advanced Head and Neck Squamous Cell CarcinomaAgedCarcinoma, Squamous CellNCT04892173Johnson & Johnson Enterprise Innovation Inc.500
招募中
1 期
Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid MalignanciesAdvanced Malignant Solid NeoplasmMetastatic Malignant Neoplasm in the LiverMetastatic Malignant Neoplasm in the LungMetastatic Malignant Solid NeoplasmNCT05039632M.D. Anderson Cancer Center40
终止
1 期
NBTXR3 Crystalline Nanoparticles and Stereotactic Body Radiation Therapy in the Treatment of Liver CancersLiver CancerNCT02721056Nanobiotix23