NCT03813836进行中（未招募）2 期
A Phase II Trial to Assess the Efficacy and Safety Profile of Pembrolizumab in Patients With Performance Status 2 With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 12
- 主要终点
- Disease control rate at 24 weeks assessed using iRECIST
研究概览
简要总结
A single-arm phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status of 2 with recurrent or metastatic squamous cell carcinoma of the head and neck. Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
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
- •Histologically confirmed locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies
- •Measurable disease evaluated by RECIST criteria version 1.1
- •WHO performance status of 2
- •Life expectancy >12 weeks
- •Aged ≥18 years of age
- •Adequate bone marrow function
- •Adequate renal function
- •Adequate liver function
- •Willing to use highly effective contraception for the duration of trial treatment and for 120 days after completion of treatment
- •Able to give informed consent, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options
- •Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits
排除标准
- •Patients with undifferentiated nasopharyngeal or sino-nasal cancers
- •Disease suitable for treatment with curative intent
- •Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent
- •Any investigational agents within 4 weeks prior to registration
- •Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration
- •Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to registration
- •Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial
- •Women who are pregnant or breast feeding
- •Grade 3 or 4 peripheral neuropathy
- •Any serious and/or unstable pre-existing medical, psychiatric or other condition that, in the treating clinician's judgment, could interfere with patient safety or obtaining informed consent
- •Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Active hepatitis B or C infection
- •Immunocompromised patients (e.g. known HIV positive status)
- •Prior organ transplantation including allogenic stem-cell transplantation
- •History of (non-infectious) pneumonitis/interstitial lung disease that required steroids, or current pneumonitis/interstitial lung disease
- •Active infection requiring systemic therapy
- •Received a live vaccine within 30 days prior to registration
- •Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- •Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent.
- •Current use of immunosuppressive medication (exceptions apply) Refer to section 7.2 for full list of eligibility criteria
研究组 & 干预措施
pembrolizumab + best supportive care
Experimental
Best supportive care and pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Disease control rate at 24 weeks assessed using iRECIST
时间窗: 24 weeks after registration
Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST
次要结局
- Disease control rate assessed using iRECIST(12 months after registration)
- Best Response Rate- measured using the change from baseline tumour size. Assessed using iRECIST.(6 months after registration)
- Progression Free Survival defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first.(From registration to 30 months post start of treatment)
- Clinical Benefit Rate -defined as patient's best response rate lasting at least 18 weeks(From start of treatment to 30 months post start of treatment)
- Duration of Response- defined as the time from first documented evidence of CR or PR until disease progression or death.(From start of treatment to 30 months post start of treatment)
- Time to Progression -defined as time from registration to the first documented disease progression(From registration to 30 months post start of treatment)
- Overall Survival- defined as the time from registration to death due to any cause.(From registration to 30 months post start of treatment)
- Frequency and severity of adverse events- throughout the patient's treatment and until 6 months after completion of trial treatment.(From date of registration until 6 months after completion of trial treatment)
研究者
研究点 (12)
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