EUCTR2016-004383-19-FR进行中（未招募）1 期
A Phase III randomized trial of avelumab-cetuximab-Radiotherapy versus standards of care in locally advanced squamous cell carcinoma of the head and neck - REACH
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
- GORTEC
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 years and = 80 years.
- •2.Performance Status ECOG 0-1
- •3.Histologically confirmed squamous cell carcinoma, previously untreated
- •4. Stage III, stage IVa (i.e. operable, but not operated) or IVb (non resectable)
- •5.Oral cavity, oropharynx, hypopharynx or larynx
- •6.Availability of pre-treatment tumour tissue sample (for PD -L1 expression, TILs and immune lanscape)
- •7. Documentation of p16 disease (HPV status for oropharyngeal tumor)
- •8.Recording of alcohol consumption and smoking history
- •9.Determination of the patient’s ability to receive cisplatin 100 mg/m2 for 3 cycles (fit / unfit)*
- •10.Written informed consent
- •* Criteria for determining if a patient is fit for receiving high dose cisplatin :
- •-Calculated creatinine clearance = 50 mL/min as determined by the CKD-EPI method
- •-Absolute neutrophil count =1 500/µL, platelets =100 000/µL, haemoglobin = 10 g/dL, aspartate (AST) and alanine transaminase (ALT) less than 2 times the upper limit of the normal range (ULN), total bilirubin = 1.5 mg/dL, serum albumin > 35 g/L.
- •-Peripheral neuropathy < grade 2
- •-No sensorineural hearing loss = grade 2 (confirmed by audiogram)
- •-Cardiac function compatible with hyperhydration with no significant heart disease
- •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 688
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
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 (stage IVc)
- •4.Active viral infection (HIV, Hepatitis B/C)
- •5.Active autoimmune disease
- •6.Active immunodeficiency or ongoing immunosuppressive therapy
- •7.Active CNS disease
- •8.Interstitial lung disease
- •9.Active infection
- •10.Any prior or current treatment for invasive head and neck cancer. This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, induction chemotherapy, prior surgical resection or RT, or use of any investigational agent
- •11.Concurrent treatment with any other systemic anti-cancer therapy that is not specified in the protocol
- •12.Concomitant treatment with any drug on the prohibited medication list such as live vaccines (for details, see the protocol)
- •13.History of other malignancy within the last 3 years (exception of in situ carcinoma, skin carcinomas,thyroid papillary carcinoma, localized prostate carcinoma Gleason 6 and in situ breast carcinoma)
- •14.If Pregnant patients, 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 60 days after the last dose of avelumab
- •15.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 reaction to study drugs
- •17.Any social, personal, medical and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent
- •18.Prior organ transplantation including allogenic stem-cell transplantation
- •19.Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- •20.Persisting toxicity related to prior therapy or pre-existing conditions (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade = 2, or other Grade = 2 not constituting a safety risk based on investigator’s judgment are acceptable
- •21.Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •22.Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
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