NCT06496178进行中（未招募）3 期
A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Merus B.V.
- 入组人数
- 621
- 试验地点
- 613
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
详细描述
This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed ICF before initiation of any study procedures.
- •Age ≥ 18 years at signing of ICF.
- •Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
- •HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.
- •The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- •A baseline new tumor sample unless the participant has an available tumor sample as an FFPE block with sufficient material.
- •Measurable disease as defined by RECIST v1.1 by radiologic methods.
- •ECOG PS of 0 or 1
- •Life expectancy ≥ 12 weeks, as per investigator
- •Adequate organ function (as per protocol)
排除标准
- •Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization.
- •Known leptomeningeal involvement
- •Any systemic anticancer therapy within 4 weeks prior to randomization.
- •Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.
- •Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
- •History of hypersensitivity reaction to any of the excipients of treatment required for this study.
- •Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
- •History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)
- •Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
- •Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
- •Participants with known infectious diseases (as per protocol)
- •Pregnant or breastfeeding participants
研究组 & 干预措施
MCLA-158
Experimental
干预措施: Petosemtamab (Drug)
Investigator's Choice
Active Comparator
干预措施: Investigator's Choice (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 3 years
OS was defined as the time from randomization to death due to any cause.
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
时间窗: Up to approximately 2 years
ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.
次要结局
- Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review(Up to approximately 2 years)
- Clinical Benefit Rate (CBR) as Assessed by Investigator Review(Up to approximately 2 years)
- Objective Response Rate (ORR) as Assessed by Investigator Review(Up to approximately 2 years)
- Time to Response (TTR) as Assessed by Blinded Independent Central Review(Up to approximately 2 years)
- Time to Response (TTR) as Assessed by Investigator Review(Up to approximately 2 years)
- Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review(Up to approximately 2 years)
- Duration of Response (DOR) as Assessed by Blinded Independent Central Review(Up to approximately 2 years)
- Progression Free Survival (PFS) as Assessed by Investigator Review(Up to approximately 2 years)
- Duration of Response (DOR) as Assessed by Investigator Review(Up to approximately 2 years)
- Number of participants Who experienced At Least One Treatment Emergent Adverse Event (TEAE)(Up to 30 days post-last dose)
- Number of participants Who experienced At Least One Serious TEAE(Up to 30 days post-last dose)
- Number of participants Who Discontinued Study Treatment Due to TEAEs(Up to 30 days post-last dose)
- Number of participants Who Had Dose Modification Due to TEAEs(Up to 30 days post-last dose)
- Pharmacokinetic parameters(Up to first 6 cycles)
- Incidence of anti-drug antibody (ADA)(Up to 30 days post-last dose)
- Mean Change From Baseline in EORTC QLQ-C30(Up to approximately 2 years)
- Concentrations Predose And at End of Infusion(Up to first 6 cycles)
- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review(Up to approximately 2 years)
- Number of Participants who Experienced At Least One Treatment Emergent Adverse Event (TEAE)(Up to 30 days post-last dose)
- Number of Participants who Experienced At Least One Serious TEAE(Up to 30 days post-last dose)
- Number of Participants who Discontinued Study Treatment Due to TEAEs(Up to 30 days post-last dose)
- Number of Participants who had Dose Modification Due to TEAEs(Up to 30 days post-last dose)
- Mean Change From Baseline in EuroQol EQ-5D-5L(Up to approximately 2 years)
- Scores in the Patient Global Impression of Change (PGIC) scale(Up to approximately 2 years)
- Concentrations Predose and at End of Infusion(Up to first 6 cycles)
- Mean Change From Baseline in EORTC QLQ-H&N43(Up to approximately 2 years)
研究者
研究点 (613)
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