Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: CARPACCIO (CARboplatin PAClitaxel Cetuximab IO Immuno-oncology)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study targets an adult population of patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), who have failed after a first line of treatment with pembrolizumab associated or not with chemotherapy and having an indication for a second line of treatment. Patients will be recruited in France in medical oncology departments.
The main objective is to evaluate the objective response rate of PCC in patients with HNSCC with locoregional and/or distant 2nd line metastatic disease after failure of pembrolizumab +/- chemotherapy. The secondary objectives of the study are to evaluate other efficacy parameters by monitoring the progression of the disease, the tolerance of the treatment by collecting adverse effects and quality of life.
The duration of participation in the research is 12 months.
详细描述
Head and neck squamous cell carcinoma (HNSCC) is the 7th most common cancer worldwide.
First-line treatment was shaken up in 2019 by showing that a combination of platinum, 5-fluorouracil (5-FU) and the anti-cell death program-1 (PD-1) immunotherapy, pembrolizumab, improved significantly improved overall survival (OS) compared to the standard EXTREME regimen (platinum, 5-FU and cetuximab).
After this first line and in the absence of a randomized therapeutic trial, the therapeutic strategy is not known. Possible chemotherapies are paclitaxel or methotrexate.
Systemic treatment is indicated for patients with locoregional recurrence not eligible for radiotherapy or surgery with curative intent, or progression of distant metastatic disease.
Cetuximab is approved as a second-line treatment in the United States. For patients whose tumor progresses on pembrolizumab maintenance therapy with a platinum-free interval of at least 3 months, restarting platinum therapy is potentially effective. The combination of platinum with cetuximab and paclitaxel is then possible and potentially more effective than monotherapy, including in fragile patients.
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
- •Age greater than or equal to 18 years at inclusion
- •Cytological or histological confirmation of the diagnosis of invasive squamous cell carcinoma of the head and neck
- •One of the following locations: oral cavity, oropharynx (known p16 status), larynx or hypopharynx
- •Cancers of unknown primary (CUP) of the head and neck are accepted
- •Metastatic (stage IVc) or recurrent disease in patients ineligible for curative surgical treatment or radiotherapy
- •Indication of a 2nd line after pembrolizumab +/- chemotherapy
- •Chemotherapy-free interval ≥ 3 months
- •ECOG Performance Index (Performance Index) of 0, 1 or 2
- •Patient with a life expectancy of at least 12 weeks
- •Documented progression of a measurable tumor target according to RECIST 1.1
- •Correct biology
- •Patient (male or female of childbearing potential) using a highly effective contraceptive method
- •Willingness and ability to comply with the visit schedule, treatment regimens, examinations and other procedures planned in the study
- •Patient enrolled in a health insurance plan or beneficiary of such a plan
- •Signed informed consent obtained before inclusion (after giving clear, fair and appropriate information)
排除标准
- •Other histology
- •Nasal, paranasal and nasopharyngeal cavities
- •Symptomatic or active brain parenchymal metastases or leptomeningeal tumors
- •Grade ≥2 neuropathy
- •Patients may have previously received radiotherapy. A minimum period of 2 weeks is necessary between palliative or analgesic radiotherapy and the start of treatment
- •Clinically significant heart disease or congestive heart failure NYHA (New York Heart Association) class 2 or greater. Patients must not have had unstable angina (symptoms of angina at rest) or new angina in the last 3 months or myocardial infarction in the last 6 months.
- •History of other primary malignancies, except curatively treated malignancies with no evidence of recurrence, within 3 years before the first dose of treatment and a low potential risk of recurrence or non-recurrent skin cancer. melanoma or lentigo maligna properly treated without evidence of disease or carcinoma in situ adequately treated without evidence of disease. A history of T1 grade bladder cancer or T1 grade kidney cancer is accepted. Cervical carcinoma in situ or breast cancer in situ are accepted. Patients with papillary thyroid carcinoma, basal cell skin carcinoma are accepted. A history of prostate cancer is allowed if it is less than or equal to stage T2N0M0 and a Gleason score of
- •Known hypersensitivity to the active substance or excipient of the treatments under study
- •Any uncontrolled intercurrent pathology
- •Any psychiatric illness/social situation that may limit compliance with study procedures or prevent the patient from giving written informed consent
- •Any chemotherapy or radiotherapy performed within 4 weeks of the first dose of study drug, except palliative radiotherapy to a non-target lesion
- •Major surgery within 4 weeks before the first administration of treatment. Local palliative surgery for isolated lesions is tolerated
- •Phenytoin prescribed for prophylaxis
- •Administration of a live attenuated vaccine within 30 days before the first administration of study treatment, as well as during the duration of study treatment and up to 6 months after the last dose of treatment
- •Participation in another clinical trial of an investigational treatment during the 4 weeks preceding the first administration of the study treatment
- •Pregnant or breastfeeding women
- •Women of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment.
- •Patients presenting hemorrhagic tumor
- •History of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose)
- •Patient presenting interstitial lung disease
- •History of organ transplant
- •Concomitant treatment with Hypericum
研究组 & 干预措施
PCC
干预措施: PCC (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: every 90 days up to 12 months
Best radiological response according to RECIST 1.1 criteria Number of patients who had an objective response within 12 months CT or MRI (PET scan is not validated for response evaluation) The evaluation is carried out by the investigator.
次要结局
- Progression-free survival(Every 90 days up to 12 months then according to local practices until the date of first documented progression or date of death from any cause or until 5 years, whichever came first)
- Overall survival(From date of treatment initiation until the date of death or lost to follow-up or until 5 years, whichever came first)
- Response duration(Every 90 days up to 12 months then according to local practices until the date of first documented progression or date of death from any cause or until 5 years, whichever came first)
- Patient Safety(At 12 months)
- Patient Quality of life(every 90 days up to 12 months)