NCT06446570已完成2 期
Phase II Study of Durvalumab +/- Tremelimumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
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
- 18
- 试验地点
- 1
- 主要终点
- Response rate (RR)
研究概览
简要总结
Phase II study of Durvalumab+/- Tremelimumab in patients with recurred metastatic head and neck squamous cell carcinoma
详细描述
Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent or metastatic HNSCC, regardless of PD-L1 or HPV status
- •ECOG PS 0-1
- •Ineligibility for local therapy (surgery or radiotherapy)
- •Prior palliative chemotherapy including platinum-based chemotherapy. When recurred within 6 months of definitive/neoadjuvant/adjuvant chemo- or chemoradiation, the chemotherapy is considered a line of therapy
- •At least one measurable lesion by RECIST ver 1.1
- •Adequate organ function for treatment
- •Absolute neutrophil count (ANC) ≥1000 cells/mm3
- •Hemoglobin: ≥ 9.0 g/dL
- •Platelets ≥100,000 cells/mm3
- •Estimated creatinine clearance ≥40 mL/min, or serum creatinine <1.5 x institution upper limit of normal
- •Bilirubin ≤1.5 x upper limit of normal (ULN)
- •AST (SGOT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases)
- •ALT (SGPT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases)
- •12-Lead electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
- •The patient has provided signed informed consent
排除标准
- •Previous treatment with PD-1 or PDL-1 inhibitors
- •Nasopharyngeal carcinoma
- •Cytotoxic chemotherapy within 3 weeks of study entry; immunotherapy or investigational drug within 5 half-lives of study entry
- •Any major operation or irradiation within 4 weeks of baseline disease assessment. Palliative radiation is allowed
- •Symptomatic brain metastasis
- •Patients with known interstitial lung disease
- •Patients with uncontrolled or significant cardiovascular disease
- •Previous or concurrent malignancy (except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, thyroid cancer treated curatively) without evidence of recurrence for at least 3 years prior to study entry.
- •Pregnant or breast-feeding women
- •Systemic immunosuppressive therapy
- •Active autoimmune disease
- •Patient who have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies) (inactive HBV carrier with adequate prophylactic antiviral agent can be enrolled)
- •Body weight <30kg
- •Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation
研究组 & 干预措施
Durvalumab, tremelimumab
Experimental
Durvalumab is a human immunoglobulin (Ig) G1 kappa (IgG1κ) monoclonal antibody (mAb) that blocks the interaction of PD-L1 with PD-1 on T-cells and CD80 on immune cells and is engineered to reduce antibody-dependent cell-mediated cytotoxicity.(IV class)
Tremelimumab is specific for human CTLA-4; cluster of differentiation a cell surface receptor that is expressed primarily on activated T cells and acts to inhibit their activation.(IV class)
干预措施: Durvalumab,Tremelimumab (Drug)
结局指标
主要结局
Response rate (RR)
时间窗: 24months
RECIST1.1
次要结局
- •Progression-Free Survival (PFS)(24months)
- •Overall Survival (OS)(24months)
- •biomarker(24months)
- •Toxicity(24months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCCHepatocellular Carcinoma Non-resectableHCCNCT04522544Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest55
进行中（未招募）
2 期
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRASCarcinoma, Non-Small-Cell LungNCT06008093AstraZeneca103
已完成
2 期
Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck CancerHead and Neck CancerNCT00713219Memorial Sloan Kettering Cancer Center14
已完成
2 期
Pulmonary sarcomatoid_MEDI4736+TremeDurvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLCNCT03022500Seoul National University Hospital32
已完成
2 期
A Phase II Study of Durvalumab and Tremelimumab in combination with Neoadjuvant Carboplatin and Paclitaxel in newly diagnosed women with advanced high grade Serous Ovarian, Fallopian Tube and Peritoneal Cancers iPRIME”.Fallopian tube cancerPeritoneal cancerCancer - Ovarian and primary peritonealOvarian cancerACTRN12618000109202Australia New Zealand Gynaecological Oncology Group (ANZGOG)75