Phase II Multicentric Study: Efficacy Evaluation of Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy on Disease-free-survival (DFS) in Patients With Resectable Head and Neck Mucosal Melanoma
概览
- 阶段
- 2 期
- 干预措施
- Pembrolizumab
- 疾病 / 适应症
- Head and Neck Mucosal Melanomas
- 发起方
- Gustave Roussy, Cancer Campus, Grand Paris
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease Free Survival
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
The main objective will be to estimate the disease free survival (DFS) of patients with resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 (in combination or not with lenvatinib) followed by surgery, radiotherapy and maintenance immunotherapy in order to compare it to historical DFS results of this kind of patients treated by surgery and radiotherapy. Our primary end-point will be disease-free survival at 2 years
研究者
入排标准
入选标准
- •Be willing and able to provide written informed consent/assent for the trial.
- •Be \>/= 18 years of age on day of signing informed consent.
- •Present with a resectable head and neck mucosal melanoma.
- •Be eligible for surgical treatment (without any contraindications).
- •Be eligible for adjuvant radiotherapy.
- •Have measurable disease based on RECIST 1.
- •Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day
- •Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
- •Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •Demonstrate adequate organ function as defined in table 1, all screening labs should be performed within 10 days of treatment initiation.
排除标准
- •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •Has a metastatic disease.
- •Has a non resectable melanoma.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (except topical or inhaled steroids) or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of trial treatment.
- •Has a known history of active TB (Bacillus Tuberculosis)
- •Hypersensitivity to pembrolizumab or any of its excipients.
- •Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to D1 of study treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks or 5 half-life times (whatever the shorter) prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- •Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
研究组 & 干预措施
Cohort A
The cohort A (Pembrolizumab only) will be opened in a first study step. Anti-PD1 antibody will be used (pembrolizumab, Merck®) intravenously at a dose of 200 mg every 3 weeks (4 injections maximum over 12 weeks), monotherapy
干预措施: Pembrolizumab
Cohort A
The cohort A (Pembrolizumab only) will be opened in a first study step. Anti-PD1 antibody will be used (pembrolizumab, Merck®) intravenously at a dose of 200 mg every 3 weeks (4 injections maximum over 12 weeks), monotherapy
干预措施: Surgery
Cohort A
The cohort A (Pembrolizumab only) will be opened in a first study step. Anti-PD1 antibody will be used (pembrolizumab, Merck®) intravenously at a dose of 200 mg every 3 weeks (4 injections maximum over 12 weeks), monotherapy
干预措施: IMRT
Cohort B
Up to 26 evaluable patients will be treated in the cohort B (Pembrolizumab with Lenvatinib) if they do not have any contraindication for receiving lenvatinib treatment, otherwise they will be treated in the cohort A if slots are available. In the cohort B, the neo-adjuvant anti-PD1 immunotherapy will be combined with orally lenvatinib at a daily dose of 20 mg for 6 weeks started on the day of the first anti-PD1 dose.
干预措施: Pembrolizumab
Cohort B
Up to 26 evaluable patients will be treated in the cohort B (Pembrolizumab with Lenvatinib) if they do not have any contraindication for receiving lenvatinib treatment, otherwise they will be treated in the cohort A if slots are available. In the cohort B, the neo-adjuvant anti-PD1 immunotherapy will be combined with orally lenvatinib at a daily dose of 20 mg for 6 weeks started on the day of the first anti-PD1 dose.
干预措施: Surgery
Cohort B
Up to 26 evaluable patients will be treated in the cohort B (Pembrolizumab with Lenvatinib) if they do not have any contraindication for receiving lenvatinib treatment, otherwise they will be treated in the cohort A if slots are available. In the cohort B, the neo-adjuvant anti-PD1 immunotherapy will be combined with orally lenvatinib at a daily dose of 20 mg for 6 weeks started on the day of the first anti-PD1 dose.
干预措施: IMRT
Cohort B
Up to 26 evaluable patients will be treated in the cohort B (Pembrolizumab with Lenvatinib) if they do not have any contraindication for receiving lenvatinib treatment, otherwise they will be treated in the cohort A if slots are available. In the cohort B, the neo-adjuvant anti-PD1 immunotherapy will be combined with orally lenvatinib at a daily dose of 20 mg for 6 weeks started on the day of the first anti-PD1 dose.
干预措施: Lenvatinib
结局指标
主要结局
Disease Free Survival
时间窗: Up to 2 years