EUCTR2021-002163-22-DE进行中（未招募）1 期
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
anobiotix SA0 个研究点目标入组 500 人开始时间: 2021年11月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 <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
- •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.
- •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)
- •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
排除标准
- •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 <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 infec
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
招募中
3 期
BTXR3 With or Without Cetuximab in Locally Advanced Head & Neck Squamous Cell Carcinoma (LA-HNSCC)CTRI/2022/12/048448anobiotix SA
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