NCT04884997招募中2 期
An Exploratory Study of PD-1 Antibody(Toripalimab) or Combining With Temozolomide for Injection in the Treatment of Advanced/Metastatic Malignant Melanoma
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年3月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This study evaluate toripalimab or combining with temozolomide for injection in the treatment of advanced/metastatic malignant melanoma. Participants in arm A receive toripalimab, in arm B receive toripalimab plus temozolomide
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- ••Confirmed pathologic or cytologic diagnosis of advanced/metastatic malignant melanomawithout BRAF V600E mutation
- •ECOG PS 0-1;
- •Age :18 ~75 years old;
- •There were measurable lesions according to RECIST 1.1 and the lesions that had been irradiated showed definite progression after radiotherapy and the lesion was considered measurable only if it was not the only lesion
- •Proper function of the cardiovascular system, liver, kidney and bone marrow ;
- •Subject with at most one systemic therapy for advanced/metastatic malignant melanoma
- •Survival is expected to exceed 3 months
- •The subjects showing good compliance voluntarily participated in the study and signed the informed consent
排除标准
- ••Previously treated with TMZ, PD-1, or PD-L1;
- •Complicated with other malignant tumors;
- •Subjects with central nervous system metastases and/or cancerous meningitis;(Unless the subjects are asymptomatic or have been treated , no radiographic evidence of new BMs or BMs enlargement is found at least 2 weeks after BMs treatment.If the subjects have active or new untreated asymptomatic central nervous system (CNS) metastases found on imaging during the screening phase,they must receive radiotherapy
- •Uncontrolled pleural effusion ,pericardial effusion or ascites requiring repeated drainage
- •Received major surgical treatment or significant traumatic injury within Random 28 days prior
- •Severe arterial/venous thrombosis events，Such as cerebrovascular accident (including temporary ischemic attack) ,deep vein thrombosis and pulmonary embolismwithin Random 6 months prior
- •Subjects with a history of psychotropic substance abuse and being unable to get rid of it or with mental disorders
- •Subjects with any severe and/or uncontrolled disease,including :
- •Subjects with poor blood pressure control (systolic≥ 150 mmHg or diastolic ≤100mmHg)
- •Subjects with myocardial ischemia or myocardial infarction or arrhythmia above grade I (including male QTC ≥450ms(male) and female QTC ≥470ms) And ≥grade 2 congestive heart failure (New York Heart Association (NYHA))
- •Active or uncontrolled severe infection (≥CTC AE grade 2 infection)
- •liver cirrhosis,active hepatitis*;*active hepatitis(Hepatitis B reference: HBsAg positive, and HBV DNA test value exceeds the normal valueHepatitis C reference: HCV antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value
- •HIV infected
- •Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L)
- •urine protein≥++,andConfirmated 24-hour urinary protein quantification>1.0 g
- •Subjects received a preventive vaccineor attenuated vaccine within 4 weeks
- •prior to first administration
- •Participated in other clinical trials within 4 weeks
- •Active autoimmune disease（Such as the following, but not limited to: autoimmune hepatitis interstitial pneumonia enteritis vasculitis, nephritis。Subjects with asthma requiring bronchodilators for medical intervention were not included） requiring systemic treatment（Such as the use of palliative drugs, corticosteroids, or immunosuppressants） occurred within 2 years prior to initial administration.Alternative therapy(Examples include thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy
- •Other conditions that investigators consider the patients are not suitable
研究组 & 干预措施
Arm A
Active Comparator
toripalimab 3mg/kg, Q2w;
干预措施: toripalimab (Drug)
Arm B
Experimental
toripalimab 3mg/kg, Q2w; Temozolomide 150mg/m2,d1-5,Q4w
干预措施: toripalimab (Drug)
Arm B
Experimental
toripalimab 3mg/kg, Q2w; Temozolomide 150mg/m2,d1-5,Q4w
干预措施: Temozolomide Injection (Drug)
结局指标
主要结局
ORR
时间窗: 8 weeks
objective response rate
次要结局
- 2-year OS(2 year after treatment initiation)
- DCR(8 weeks)
- 1-year PFS(1 year after treatment initiation)
- 1-year OS(1 year after treatment initiation)
- OS(3 years)
- PFS(1 years)
- 6-month PFS(6 months after treatment initiation)
研究者
Yulong Zheng
Principal Investigator
First Affiliated Hospital of Zhejiang University
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Toripalimab Combined With Surufatinib for Locally Advanced Thyroid Cancer: a Phase II StudyThyroid CancerNCT04524884Fudan University10
Unknown
2 期
Efficacy and Safety of Toripalimab Combined With Docetaxel or Nab-paclitaxel in Patients With Advanced Gastric CancerGastric Cancer Stage IVNCT04563975Tao Zhang54
招募中
2 期
Toripalimab（JS001） as Monotherapy in Participants With POLE or POLD-1 Mutated and Non-MSI-H Advanced Solid TumorsSolid TumorAdvanced CancerNCT03810339Sun Yat-sen University35
招募中
2 期
Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of SNMM After Endoscopic SurgeryMalignant MelanomaSinonasal MelanomaNCT04879654Eye & ENT Hospital of Fudan University45
Unknown
2 期
Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC PatientsHead and Neck Squamous Cell CarcinomaNCT04164238First Affiliated Hospital of Zhejiang University90