NCT07633613尚未招募4 期
Pharmacokinetic Study of Pembrolizumab and Its Impact on Immunity and the Tumor Microenvironment, Which May Explain the Efficacy of Post-immunotherapy Chemotherapy.
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 110
研究概览
简要总结
This is a single-center pharmacokinetic study evaluating the impact of residual pembrolizumab levels on the efficacy of salvage chemotherapy following immunotherapy in patients with non-small cell lung cancer (NSCLC) or recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative local treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients over 18 years of age
- •- Patients diagnosed with :
- •Non-small cell lung cancer (NSCLC), including adenocarcinoma and squamous cell carcinoma.
- •Head and neck squamous cell carcinoma, p16-negative for oropharyngeal tumors.
- •Recurrent and/or metastatic tumor not amenable to curative locoregional treatment.
- •Disease progression under Pembrolizumab immunotherapy, administered at the standard dose of 200 mg every 3 weeks, as first-line treatment for metastatic disease, regardless of the number of cycles received, either as monotherapy or in combination with chemotherapy, as defined below:
- •For pulmonary adenocarcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) and Pemetrexed
- •ii. Maintenance therapy with Pembrolizumab, with or without Pemetrexed.
- •For pulmonary squamous cell carcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin) and Paclitaxel
- •+/- ii. Maintenance therapy with Pembrolizumab alone.
- •For head and neck squamous cell carcinomas : i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) ± 5-Fluorouracil (5-FU) or Paclitaxel
- •+/- ii. Maintenance therapy with Pembrolizumab alone.
- •Eligibility for salvage chemotherapy within standard care:
- •For pulmonary adenocarcinomas: weekly Paclitaxel, with or without Bevacizumab.
- •For pulmonary squamous cell carcinomas: Gemcitabine monotherapy.
- •For head and neck squamous cell carcinomas: weekly Paclitaxel and/or Cetuximab. Standard salvage chemotherapy may be initiated between Day 18 and Day 35 following the last Pembrolizumab injection, at standard doses.
- •Measurable disease according to RECIST 1.1 criteria.
- •Performance status (PS) 0 to
- •Baseline laboratory results meeting the usual criteria permitting initiation of salvage chemotherapy.
- •Patients who has voluntarily agreed to participate in the study (including additional blood sampling) and has signed the informed consent form.
- •For the subpopulation with accessible tissue biopsy:
- •Patient agrees to undergo biopsy,
- •INR < 1.5, Platelets > 50000/μL.
- •Patients covered by a social security health insurance scheme.
排除标准
- •History of cancer, except for cancers in complete remission for more than 3 years, fully resected cutaneous basal cell carcinomas, or treated carcinoma in situ or cervical intraepithelial neoplasia (in situ cervical epithelioma),
- •Patients participating in another clinical trial for which an exclusion period is specified,
- •Minor patients,
- •For the subpopulation with accessible tissue biopsy, patients receiving:
- •Clopidogrel (hydrogen sulfate) or Prasugrel (hydrochloride) or Ticlopidine (hydrochloride) without the possibility of discontinuation for 5 days,
- •Low-molecular-weight heparin (LMWH) without the possibility of dose suspension prior to the procedure,
- •Or Fondaparinux without the possibility of discontinuation,
- •Or Abciximab without the possibility of discontinuation for 24 hours and aPTT < 50s and ACT < 150s,
- •Or Eptifibatide or Tirofiban hydrochloride monohydrate or Argatroban without the possibility of discontinuation 4 hours before the procedure,
- •Or Bivalirudin without the possibility of discontinuation 2-3 hours before the procedure if CrCL > 50 mL/min, or 3-5 hours if CrCL < 50 mL/min,
- •Or Dabigatran etexilate without the possibility of discontinuation 2-3 days before the procedure if CrCL > 50 mL/min, or 3-5 days if CrCL < 50 mL/min.
- •Vulnerable persons as defined in Articles L1121-5 to L1121-8 :
- •Pregnant women, women in labour, and breastfeeding mothers,
- •Persons deprived of liberty by judicial or administrative decision, and persons hospitalized without consent under Articles L3212-1 and L3213-1 who do not fall under the provisions of Article L1121-8,
- •Persons admitted to a health or social care institution for purposes other than research,
- •Adults under legal protection measures or unable to express their consent.
研究组 & 干预措施
Residual Pembrolizumab Exposure Assessment
Experimental
干预措施: Blood sampling (Biological)
Residual Pembrolizumab Exposure Assessment
Experimental
干预措施: Tumor biopsies for biobank establishment (optional) (Procedure)
研究者
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