A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 287
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
详细描述
Participants will undergo a screening assessment over a period of less than or equal to (<=) 28 days to determine eligibility.
Eligible participants will be treated by the Investigator's choice of RT alone or RT in combination with cetuximab. Following the Investigator's choice, participants will be randomized in a 1:1 ratio:
- Arm A: JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab
- Arm B: Investigator's choice of RT alone or RT in combination with cetuximab
All participants (Arm A and Arm B) will receive 70 Gy in 35 fractions over a 7 week period.
An EOT visit will be performed 4 weeks after the completion of RT. Follow-up visits will start at 12 weeks post-RT completion, and will continue every 12 weeks for 2 years, and then every 24 weeks thereafter until death; the participant is determined to be lost to follow up; withdrawal of consent; or the end of the study, whichever occurs first. Participants who have received further anti-cancer therapy for the study disease and/or have had disease progression/recurrence will be followed only for survival information
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to (>=) 60 years old
- •Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
- •Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
- •One primary tumor lesion amendable for intratumoral injection
- •Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):
- •Estimated creatinine clearance >= 30 and less than (<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
- •Grade >= 2 hearing loss or tinnitus,
- •Grade >= 2 peripheral neuropathy,
- •New York Heart Association Class 3
- •Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14 or Aged >= 75 years old
- •Eastern cooperative oncology group (ECOG) performance status 0 to 1
- •Life expectancy >= 6 months
排除标准
- •Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin
- •Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
- •Loco-regionally recurrent head & neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
- •Prior or concurrent primary malignancy (including second synchronous head & neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
- •Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization
研究组 & 干预措施
Arm A: JNJ-90301900 (NBTXR3)
JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.
干预措施: JNJ-90301900 (NBTXR3) (Drug)
Arm A: JNJ-90301900 (NBTXR3)
JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.
干预措施: Radiation Therapy (Radiation)
Arm B: RT alone or RT in combination with cetuximab
Investigator's choice of RT alone or RT in combination with cetuximab.
干预措施: Cetuximab (Drug)
Arm A
JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.
干预措施: Cetuximab (Drug)
Arm B
Investigator's choice of RT alone or RT in combination with cetuximab.
干预措施: Cetuximab (Drug)
Arm A: JNJ-90301900 (NBTXR3)
JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.
干预措施: Cetuximab (Drug)
Arm B: RT alone or RT in combination with cetuximab
Investigator's choice of RT alone or RT in combination with cetuximab.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 30 months following first randomized participant
Time from randomization to local-regional recurrence, local-regional progression, distant progression, or death from any cause, whichever occurs first
次要结局
- Overall Survival (OS)(48 months following first randomized participant)
- Local-regional control(48 months following first randomized participant)
- Distant control(48 months following first randomized participant)
- Objective Response Rate (ORR)(48 months following first randomized participant)
- Duration of Overall Response(48 months following first randomized participant)
- Quality of Life over time - QLQ H&N35(48 months following first randomized participant)
- Quality of Life over time - EQ 5D 5L(48 months following first randomized participant)
- Safety across duration of study - AEs(48 months following first randomized participant)