2024-513206-65-00招募中3 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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 675
- 试验地点
- 78
- 主要终点
- Disease free survival (DFS by investigator imaging assessments) defined as the time between the date of randomization and the date of first loco-regional or distant recurrence or death (of any cause) whichever occurs first,..
研究概览
简要总结
To determine the efficacy of nivolumab + cisplatin-RT relative to SOC cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 75 years
- •Squamous cell carcinoma of the head and neck treated by primary surgery
- •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)
- •Subject must have complete macroscopic resection.
- •Subject must be free of disease
- •Recovery from the surgical procedure allowing for cisplatin-Radiotherapy
- •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
- •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.
- •Adequate tumor specimen from archived or resected tissue available for PD-L1, TILs and immune landscape and other biomarker evaluation
- •Performance Status (PS) ECOG 0-1
- •Written informed consent
- •Recording of alcohol consumption and smoking history
- •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
排除标准
- •Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
- •Incomplete macroscopic resection (R2), as stated in the surgical report
- •Squamous cell carcinoma involving cervical neck nodes with unknown primary site
- •Active central nervous system disease
- •Interstitial lung disease
- •Active infection
- •Metastatic disease
- •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
- •Concurrent treatment with any other systemic anti-cancer therapy that is not specified in the protocol
- •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
- •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)
- •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
- •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.
- •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
- •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
- •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
结局指标
主要结局
Disease free survival (DFS by investigator imaging assessments) defined as the time between the date of randomization and the date of first loco-regional or distant recurrence or death (of any cause) whichever occurs first,..
Disease free survival (DFS by investigator imaging assessments) defined as the time between the date of randomization and the date of first loco-regional or distant recurrence or death (of any cause) whichever occurs first,..
次要结局
- Overall survival
- DFS by blinded independent central imaging review
- DFS and OS by PDL-1 status
- Cumulative incidence of locoregional failure, cumulative incidence of distant metastatic failure and cumulative incidence of death without previous progression
- Incidence of second primary malignancy (SCC to a distance >= 3 cm from the tumor bed and that will clearly not be attributable to a relapse or a second cancer arising outside the upper aero digestive track).
- Safety: Adverse events and laboratory abnormalities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0). Incidence of delayed toxicity of radiotherapy (e.g. dysphagia, chronic swallowing dysfunctions, speech problems, cervical fibrosis, rate and duration of the use of feeding tubes).
- Correlation between the immune landscape and patients’ outcome
研究者
Yun Gan TAO
Scientific
Groupe Oncologie Radiotherapie Tete Cou
研究点 (78)
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