A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 20
- 主要终点
- Number of Participants with Adverse Events (AEs) by Severity
研究概览
简要总结
This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth & throat).
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx
- •Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines
- •A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines
- •Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
排除标准
- •Primary tumor originating in the nasopharynx, paranasal sinuses, salivary glands, thyroid gland, parathyroid gland, skin, or unknown primary site
- •Non-squamous histology
- •Stages 0, I, II, and IVC HNSCC, loco-regionally recurrent HNSCC, or synchronous second primary HNSCC (within 2 months)
- •Ineligible to receive platinum-based chemotherapy
- •Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients
研究组 & 干预措施
JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)
Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.
干预措施: Cisplatin (Drug)
JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)
Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.
干预措施: JNJ-90301900 (Drug)
JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)
Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.
干预措施: Intensity Modulated Radiation Therapy (IMRT) (Radiation)
JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)
Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.
干预措施: Carboplatin (Drug)
JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)
Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) by Severity
时间窗: Up to approximately 2 years 14 weeks
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0.
次要结局
- Complete Response (CR) Rate(Up to approximately 2 years 14 weeks)
- Disease Control Rate (DCR)(Up to approximately 2 years 14 weeks)
- Number of Participants with Post-Radiation Primary Surgery(Up to approximately 2 years 14 weeks)
- Objective Response Rate (ORR) According to RECIST v.1.1(Up to approximately 2 years 14 weeks)
- Complete Response (CR) Rate(Up to approximately 2 years 12 weeks)
- Disease Control Rate (DCR)(Up to approximately 2 years 12 weeks)
- Injected Tumor Response Rate(Up to approximately 2 years 14 weeks)
- Time to Locoregional Failure (LRF)(Up to approximately 2 years 14 weeks)
- Time to Distant Failure (DF)(Up to approximately 2 years 14 weeks)
- Progression Free Survival (PFS)(Up to approximately 2 years 14 weeks)
- Number of Participants with Post-Radiation Neck Dissection (PRND)(Up to approximately 2 years 14 weeks)
- Number of Participants with Post-Radiation Primary Salvage Surgery(Up to approximately 2 years 14 weeks)