NCT02643550已完成1 期
Phase 1b/2 Trial of IPH2201 And Cetuximab in Patients With Human Papillomavirus (HPV) (+) and HPV (-) Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 22
- 主要终点
- Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study
研究概览
简要总结
The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 ≥ 18 years
- •Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis, glottis, subglottis) or oral cavity.
- •Recurrent or metastatic disease, documented by imaging (CT scan, MRI, X-ray) and/or physical examination with measurable disease as per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1
- •For phase II cohorts:
- •Cohort #1: Patients who received a maximum of two prior systemic regimens for recurrent and/or metastatic disease and not amenable to further therapy with curative intent
- •Cohort #2: Patients with R/M SCCHN not amenable to therapy of curative intent, who have received a maximum of two prior systemic regimens in the R/M setting and who have received prior PD-(L)1 blockers
- •Cohort #3: Patients with R/M SCCHN who have not received prior systemic regimens in the R/M setting and who have not received prior PD-(L)1 inhibitors
排除标准
- •For phase II cohort #1 and cohort #2: Patients who received more than 2 prior systemic regimens for recurrent and/or metastatic disease (no restriction in the phase Ib part of the trial).
- •For phase II cohort #1 and cohort #2: Patients who received cetuximab or another inhibitor of epidermal growth factor receptor are excluded from the phase II of the trial, except if cetuximab was given as part of a primary treatment approach, with no progressive disease for at least 4 months following the end of prior cetuximab treatment.
结局指标
主要结局
Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study
时间窗: within 4 weeks after first administration
To assess the occurrence of Drug Limited Toxicities (DLTs)
Objective Response Rate for expansion cohorts
时间窗: up to 12 months
rate of patients in complete or partial response according to RECIST 1.1.
次要结局
- Objective Response Rate for dose escalation part of the study(up to 12 months)
- Progression Free Survival for expansion cohorts(Until disease progression or death, up to 2 years)
- Overall Survival for expansion cohorts(Until death, up to 2 years)
- Duration of Response for expansion cohorts(From confirmed response until disease progression, up to 12 months)
研究者
研究点 (22)
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