EUCTR2017-004936-13-GR进行中（未招募）1 期
A phase III randomized trial of post-operative adjuvant nivolumab and concomitant chemo-radiotherapy in high-risk patients with resected squamous cell carcinoma of head and neck (SCCHN) - NIVO POST-OP
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GORTEC
- 入组人数
- 680
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. Age > 18 and < 75 years
- •2. Performance Status (PS) ECOG 0-1 (Appendix 2)
- •3. Written informed consent
- •4. Recording of alcohol consumption and smoking history
- •5. Histologically proven squamous cell carcinoma of the head and neck from one or more of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx
- •6. Squamous cell carcinoma of the head and neck treated by primary surgery
- •7. Histopathological classification: pStage III or IV. However, Oropharyngeal Cancer pStage II p16 positive with pT3N1 or pT4N1 and tobacco consumption =20 packs/year are eligible. (American Joint Committee on Cancer 8th edition) 38
- •8. Subject must have complete macroscopic resection.
- •9. Subject must be free of disease
- •10. Recovery from the surgical procedure allowing for cisplatin-Radiotherapy
- •11. Radiotherapy planned to start within 4 to 9 weeks after surgery. However, a maximum of 1 additional week could be considered in case of delay due to healing or logistical problem
- •12. Patient/tumor carrying a high risk of relapse with one or more following criteria:
- •- Extra-capsular extension (ECE)
- •- Multiple peri-neural invasion
- •- Multiple nodal extension without ECE (= 4 nodes)
- •- Positive margins (R1 or close margin = 1 mm)
- •R1 is microscopic residual disease and close margin is R0 with a minimum margin = 1 mm in any direction.
- •13. Adequate tumor specimen from archived or resected tissue available for PD-L1, TILs and immune landscape and other biomarker evaluation
- •14. For oropharyngeal tumor, known p16 status (by Immunohistochemistry method)
- •15. Determination of patient ability to receive cisplatin 100 mg/m2 for 3 cycles:
- •- Creatinine Clearance (CrCl) = 60 mL/min (measured or calculated by Cockcroft and Gault method) or estimated Glomerular Filtration Rate (eGFR) = 60 mL/min/1.73m2 (determined by CKD-EPI or MDRD method). The highest value should be considered if both are assessed.
- •- Absolute neutrophil count =1 500/mm3, platelets =100 000/mm3, haemoglobin = 9 g/dL, aspartate transaminase (AST) and alanine transaminase (ALT) less than 2.5 times the upper limit of the normal range (ULN), total bilirubin = 1.5 mg/dL(except Gilbert Syndrom: < 3.0 mg/dL).
- •- Peripheral neuropathy = grade 2
- •- No hearing loss (assessed clinically and confirmed by audiogram if doubtful)
- •- Cardiac function compatible with hyperhydration
- •- No administration of prophylactic phenytoin
- •- Patients aged 71-74 years, must be fit according to geriatric evaluation
- •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 590
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
- •2. Squamous cell carcinoma involving cervical neck nodes with unknown primary site
- •3. Metastatic disease
- •4. Incomplete macroscopic resection (R2), as stated in the surgical report
- •5. Known active viral infection (Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV, active autoimmune disease and/or active immunodeficiency or ongoing immunosuppressive therapy
- •6. Active central nervous system disease
- •7. Interstitial lung disease
- •8. Active infection
- •9. Any prior treatment for the current head and neck cancer other than primary surgery. This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, induction chemotherapy, prior RT, or use of any investigational agent
- •10. Concurrent treatment with any other systemic anti-cancer therapy that is not specified in the protocol
- •11. Concomitant treatment with any drug on the prohibited medication list such as live vaccines. Live vaccines administered more than 30 days before study entry are permitted
- •12. History of other malignancy within the last 3 years (exception of in situ carcinoma, thyroid papillary carcinoma, skin carcinomas, localized prostate carcinoma Gleason 6 and in situ breast carcinoma)
- •13. Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 5 months after the last dose of nivolumab
- •14. Male patients who are unwilling or unable to use contraception methods for the duration of the study and for at least 6 months after the last dose of cisplatin
- •15. Severe acute or chronic medical conditions including colitis, pneumonitis, pulmonary fibrosis, laboratory abnormalities or other significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial
- •16. Known hypersensitivity to study drugs
- •17. Prior organ transplantation including allogenic stem-cell transplantation
- •18. Clinically significant (i.e., active) cardiovascular disease:
- •- Cerebral vascular accident/stroke (< 6 months prior to enrollment) or
- •- Myocardial infarction (< 6 months prior to enrollment) or
- •- unstable angina, congestive heart failure (= New York Heart Association Classification Class II) or
- •- Serious cardiac arrhythmia requiring medication
- •19. Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
- •20. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- •21. Any psychiatric condition (including active suicidal ideation), or psychological, or familial, or sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •22. Individuals deprived of liberty or placed under the authority of a tutor.
研究者
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