NCT04665843已完成2 期
A Phase II, Randomized, Double Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 93
- 主要终点
- Confirmed Objective Response Rate (ORR)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies
- •Known results from human papillomavirus (HPV) status test for oropharyngeal carcinoma
- •No prior systemic therapy for metastatic and/or recurrent SCCHN
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Life expectancy >=12 weeks
排除标准
- •Disease suitable for local therapy with curative intent
- •Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
- •Rapidly progressing disease in the opinion of the treating investigator
- •Grade >=2 unresolved toxicity related to surgery or other prior therapies
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •History of leptomeningeal disease
- •Active or history of autoimmune disease or immune deficiency
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •History of additional malignancy other than SCCHN within 5 years prior to randomization
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-TIGIT, anti-PD-L1, and anti-PD-1 therapeutic antibodies
- •Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
- •Pregnancy or breastfeeding
研究组 & 干预措施
Atezolizumab + Tiragolumab
Experimental
Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
干预措施: Atezolizumab (Drug)
Atezolizumab + Placebo
Placebo Comparator
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
干预措施: Placebo (Drug)
Atezolizumab + Tiragolumab
Experimental
Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
干预措施: Tiragolumab (Drug)
Atezolizumab + Placebo
Placebo Comparator
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (ORR)
时间窗: Up to approximately 43 months
次要结局
- Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab(From baseline up to approximately 43 months)
- Number of Participants With ADAs to Tiragolumab(From baseline up to approximately 43 months)
- Cmax of Tiragolumab(Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months)
- Maximum Serum Concentration (Cmax) of Atezolizumab(Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months)
- Cmin of Tiragolumab(Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months)
- Duration of Response (DOR)(Up to approximately 43 months)
- Progression-Free Survival (PFS)(Up to approximately 43 months)
- Overall Survival (OS)(Up to approximately 43 months)
- Progression-Free Survival Rate at 6 Months(Month 6)
- Overall Survival Rate at 6 Months and 12 Months(Month 6, Month 12)
- Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning(Up to approximately 43 months)
- Percentage of Participants With Adverse Events (AEs)(Up to approximately 43 months)
- Minimum Serum Concentration (Cmin) of Atezolizumab(Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months)
研究者
研究点 (93)
Loading locations...
相似试验
进行中（未招募）
2 期
A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Dual Immune Checkpoint Inhibition With Anti-PD-L1 (Atezolizumab) and Anti-TIGIT (Tiragolumab) in Cancer of Unknown PrimaryCancerNCT06754501M.D. Anderson Cancer Center4
终止
2 期
A Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)Stomach NeoplasmsGastroesophageal Junction AdenocarcinomaGastric CancerNCT04933227Hoffmann-La Roche29
已完成
3 期
A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal CarcinomaEsophageal CancerNCT04540211Hoffmann-La Roche461
已完成
2 期
A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung CancerNon-small Cell Lung CancerNCT03563716Genentech, Inc.135
进行中（未招募）
2 期
A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal CancerRectal NeoplasmsRectal CancerNCT05009069Hoffmann-La Roche58