NCT05838729招募中1 期
Phase 1b/2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Determination of Recommended Dose
研究概览
简要总结
This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with hypofractionated radiation and a PD-1 Inhibitor in patients with unresectable, recurrent or metastatic head-neck cancer.
详细描述
Primary Objectives:
- To determine the tolerability of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor (pembrolizumab or nivolumab) in patients with unresectable, recurrent or metastatic head-neck cancer
- To determine the efficacy of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor (pembrolizumab or nivolumab)
Secondary Objectives:
- To evaluate progression-free survival for up to 12 months
- To determine overall survival for up to 24 months
- To assess patient quality of life
The target population is patients with unresectable, recurrent or metastatic head-neck cancer which is clinically accessible to intratumoral injection.
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
- •Diagnosis of head-neck cancer that requires palliative radiotherapy
- •Patients with unresectable, recurrent or metastatic HNSCC, regardless if the patients have progressed on or are intolerant to platinum-based chemotherapy prior to study enrollment or if the patients are receiving pembrolizumab in the first line:
- •receiving a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care, or
- •suitable to receive a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care in the discretion of the treating physician or Principal Investigator
- •Must have at least 1 target lesion that is clinically accessible to RiMO-301 injection and amenable to receive RT regimens specified in this protocol
- •The selected target lesions must be measurable on cross-sectional imaging and repeated measurements at the same location should be achievable
- •Target tumor not in the previously irradiated field or in the field irradiated at least six months prior to RiMO-301 injection and with no complications from the prior radiation course
- •RiMO-301 injection to multiple lesions (≤ 5 in total) in a single patient is allowed as long as the total tumor volume does not exceed 250 cm3
- •Patient must have recovered from acute toxic effects (≤ grade 1 CTCAEv5) of previous cancer treatments prior to enrollment
- •Have adequate bone marrow reserve and adequate liver function
- •Have a life expectancy of at least 12 weeks
- •ECOG score of 0-2
- •Age 18 years or older
排除标准
- •Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions
- •Symptomatic central nervous system metastases and/or carcinomatous meningitis
- •Active autoimmune disease that has required systemic treatment in the past 2 years
- •Ongoing clinically significant infection at or near the incident lesion
- •Major surgery over the target area (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days. No waiting is required following implantable port, enteral feeding tube and catheter placement
- •Has received any approved or investigational anti-neoplastic agent or immunotherapy other than PD-1 inhibitors (pembrolizumab or nivolumab) within 4 weeks prior to RiMO-301 injection
- •Patients with lesions which have significant blood vessel involvement (such as carotid artery encasement) or other major structures
研究组 & 干预措施
RiMO-301
Experimental
Intratumoral injection of RiMO-301 followed by pembrolizumab or nivolumab followed by hypofractionated radiation
干预措施: RiMO-301 (Drug)
结局指标
主要结局
Determination of Recommended Dose
时间窗: 6 weeks
• The dose limiting toxicities of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor, as assessed by CTCAEv5, will not be observed in 33% or more patients
Evaluation of Anti-Tumor Response
时间窗: 12 months
• To determine the objective response rate: complete or partial response, as defined by RECIST and itRECIST
次要结局
- Evaluation of Progression-Free Survival(12 months)
- Evaluation of Overall Survival(24 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancerlocalized prostate cancerJPRN-UMIN000038279agoya City University West Medical Center300
已完成
1 期
PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of PrematurityRetinopathy of PrematurityNCT04621136Kyushu University24
进行中（未招募）
不适用
A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancer - RAPTORPatients who have metastatic papillary cancer of the kidney and have not received prior systemic treatment for their metastatic RCC. This multicenter international trial will enroll a maximum of 60 patients over a period of approximately 12 months.MedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaEUCTR2008-006181-28-FRovartis Pharma Services AG60
进行中（未招募）
不适用
A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancerPatients who have metastatic papillary cancer of the kidney and have not received prior systemic treatment for their metastatic RCC. This multicenter international trial will enroll a maximum of 60 patients over a period of approximately 12 months.MedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaEUCTR2008-006181-28-BEovartis Pharma Services AG55
进行中（未招募）
不适用
A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancer - RAPTOREUCTR2008-006181-28-DEovartis Pharma Services AG55