Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas

Institut Claudius Regaud14 个研究点分布在 1 个国家目标入组 86 人2024年10月21日

适应症Squamous Cell Carcinoma of Head and Neck

干预措施Pembrolizumab + Cisplatin/Carboplatin + 5-FU

概览

阶段: 2 期
干预措施: Pembrolizumab + Cisplatin/Carboplatin + 5-FU
疾病 / 适应症: Squamous Cell Carcinoma of Head and Neck
发起方: Institut Claudius Regaud
入组人数: 86
试验地点: 14
主要终点: The endpoint for the activity is defined by the objective response (i.e. complete or partial response) according to the RECIST v1.1 criteria, assessed by the investigator.
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is a phase II, prospective, non-randomized, single-arm, multicentric study to evaluate the activity and safety of treatment with 4 cycles (instead of 6) of chemotherapy (platinum (cisplatin or carboplatin) and 5-Fluorouracil) in combination with pembrolizumab for the first-line treatment of CPS PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.

A total of 86 patients will have to be enrolled in this study.

注册库

clinicaltrials.gov

开始日期

2024年10月21日

结束日期

2030年9月1日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Institut Claudius Regaud

责任方

Sponsor

入排标准

入选标准

•Age ≥ 18 years old on the day of signing the informed consent.
•Diagnosis of histologically proven recurrent or metastatic squamous cell carcinoma of the head and neck not accessible to treatment with curative intent.
•Patients must not have received previous systemic therapy administered in the context of recurrent or metastatic disease.
•If the patient received chemotherapy with a platinum salt as part of multimodal treatment for locally advanced disease, it must have ended at least 6 months before signing the consent.
•Eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx and larynx. Subjects cannot have a primary tumor site (any histology) in the nasopharynx, sinuses, nasal cavity, salivary glands, or skin.
•Documented Combined Positive Score (CPS) PD-L1 ≥ 1 (determined according to local practices in each center) Note: the CPS score can be performed on a new biopsy or on an archived tumor specimen, without date limitation.
•Have measurable disease on CT-scan (or on MRI of the neck if it provides a better measurement of the primary tumor according to standard practice and the investigator judgement) according to RECIST 1.1 as determined by the investigator. Tumor lesions located in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Note : In case of neck MRI assessment, the chest, abdominal, and pelvic CT scan must be performed in addition to assess potential metastases.
•Have a performance status of 0 or 1 on the ECOG performance scale.
•Demonstrate adequate organ function as defined in the protocol.
•Have HPV status test results for oropharyngeal cancers defined as a p16 immunohistochemical (IHC) test (determined according to local practices in each center).

排除标准

•Has a disease accessible to local treatment with curative intent.
•Has a progressive disease within six months following the end of primary treatment with curative intent, if this treatment included systemic treatment with platinum salt.
•Has a complete DPD enzyme deficiency, suggested by an uracilemia \> or equal to 150 ng/mL.
•Has a contraindication to full dose use of a platinum salt, 5-Fluorouracil, or pembrolizumab, in the opinion of the investigator (dose reductions in cycle 1 are not authorized, except in the case of adaptation of the 5-FU due to partial DPD deficiency); the investigator must refer to the SmPC of the products used in this trial (carboplatin, cisplatin, 5-fluorouracil, and pembrolizumab).
•The patient must not have received antibiotics within 14 days before inclusion in the trial.
•Received radiotherapy (or other non-systemic therapy) within 2 weeks prior to inclusion.
•Subject has not fully recovered (i.e. ≤ Grade 1) from adverse events due to previously administered treatment.
•Note: Subjects with neuropathy ≤ Grade 2, alopecia ≤ Grade 2, or laboratory values not exceeding the limits in Table 1 (See the protocol) are an exception to this criterion and may be eligible for the study Note: If the subject has undergone major surgery, they must have adequately recovered from the toxicity and/or complications of the procedure before starting treatment.
•Currently participating in and receiving study treatment, or has participated in a study of an investigational agent, or used an investigational device, within 4 weeks prior to the first dose of treatment.
•Note: Participation in the follow-up phase of a previous study is permitted (if the patient is no longer receiving treatment in that study).

研究组 & 干预措施

Patient with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck

干预措施: Pembrolizumab + Cisplatin/Carboplatin + 5-FU

结局指标

主要结局

The endpoint for the activity is defined by the objective response (i.e. complete or partial response) according to the RECIST v1.1 criteria, assessed by the investigator.

时间窗: 48 months for each patient

The objective response rate is defined as the ratio of the number of patients with an objective response to the total number of patients.

The endpoint for the safety is defined as the rate of patients with AE leading to all treatment discontinuation.

时间窗: 24 months for each patient

This rate is defined as the ratio of the number of patients with AE leading to all treatment discontinuation to the total number of patients.

次要结局

The objective response rate at 6 months is defined by the presence of an objective response (i.e. complete or partial response) at 6 months according to the RECIST v1.1 criteria, assessed by the investigator.(6 months for each patient)
Progression-free survival is defined by the time between the date of inclusion and the date on which a first tumor confirmed progression is documented (according to RECIST v1.1 criteria, (Eisenhauer, 2009)) or death from any causes.(48 months for each patient)
Overall survival is defined by the time between the date of inclusion and the date of death from any cause or the date of the last news (Censored Data).(48 months for each patient)
Duration of response is defined in the population of patients with an objective response.(48 months for each patient)
Safety will be assessed according to the toxicity grading of NCI CTCAE v 5.0.(48 months for each patient)