NCT04396886已完成2 期
Phase II Prospective Study of Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC)
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
- 38
- 试验地点
- 1
- 主要终点
- Evaluation of Objective Tumour Response
研究概览
简要总结
This would be a phase II prospective single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of bintrafusp alfa in previously treated patients with recurrent and metastatic (R/M) non-keratinizing nasopharyngeal carcinoma (NPC).
详细描述
All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number). Patients shall receive Bintrafusp alfa treatment through intravenous therapy every two weeks up until disease progression, unacceptable toxicity or for a maximum of 2 years. Survival Follow-up till 2 years will also be performed.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed non-keratinizing differentiated (World Health Organization WHO Type II) or undifferentiated (WHO Type III) nasopharyngeal carcinoma (NPC) that has recurred at regional or / and distant sites
- •Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease
- •Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent either for the treatment of metastatic or recurrent disease
- •Experienced progression of disease within 6 months following completion of a platinum-based combination therapy as part of (neo)-adjuvant therapy
- •Male or female subjects with age: 18-79 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •No prior immunotherapy
- •Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available
- •Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
- •Females of childbearing potential must have negative serum or urine pregnancy test
- •Have life expectancy ≥ 3 months
- •Adequate organ function as defined as: Absolute neutrophil count ≥ 1.5 x 10^9/L, Platelet count ≥ 100 x 10^9/L, Hemoglobin >= 8.0 g/dL, Serum alanine aminotransferase ([ALT]; serum glutamate-pyruvate transferase [SGPT]), or serum aspartate aminotransferase [AST] where available at the center) < 2.5 x upper limit of normal (ULN), OR < 5 x ULN in the presence of liver metastases
- •Serum total bilirubin < 2 x ULN
- •Serum creatinine < 1.5 x ULN
排除标准
- •Prior invasive malignancy within 2 years except for non-invasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured
- •Isolated local recurrence or persistent disease
- •Has disease that is suitable for local therapy administrated with curative intent
- •Severe, active co-morbidity
- •Currently participating in and receiving clinical trial treatment or has participated in a trial of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment
- •Has prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (≤ grade 1 or at baseline) from adverse events due to previous administered agent
- •Untreated active central nervous system (CNS) metastatic disease, lepto-meningeal disease, or cord compression
- •Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (≥New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- •Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms
- •Irritable bowel syndrome or other serious gastrointestinal chronic conditions associated with diarrhea within the past 3 years prior to the start of treatment
- •Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
- •On chronic systemic steroid or any other forms of immunosuppressive medication within 14 days prior to the treatment. Except: Intra-nasal, inhaled, topical steroids, or local steroid injection (e.g., intraarticular injection); Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent; Steroids as premedication for hypersensitivity reactions due to bintrafusp alfa
- •Active or prior documented autoimmune or inflammatory disorders in the past 2 years, except diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment
- •Known active hepatitis B or known hepatitis C is detected; subjects who have been treated and now have an undetectable viral load are eligible
- •History of primary immunodeficiency or solid organ transplantation
- •Receipt of live, attenuated vaccine within 28 days prior to the study treatment
- •Active infection requiring systemic therapy
- •Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
- •Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
- •Psychiatric disorders and substance (drug/alcohol) abuse
研究组 & 干预措施
Bintrafusp Alfa
Experimental
Single group assignment of bintrafusp alfa in previously treated patients with recurrent and metastatic (R/M) nonkeratinizing nasopharyngeal carcinoma (NPC)
干预措施: Bintrafusp Alfa (Drug)
结局指标
主要结局
Evaluation of Objective Tumour Response
时间窗: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
To evaluate the objective tumor response (ORR) to bintrafusp alfa in previously treated R/M NPC patients per response evaluation criteria of solid tumor (RECIST) version 1.1
次要结局
- Time-to-progression (TTP) assessment(From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years)
- Median Survival(From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years)
- Survival rate assessment(From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years)
- Toxicity and Tolerability measurement(From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years)
- Progression-Free survival assessment(From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years)
- Disease Control Rate (DCR)(From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years)
- Investigate the relationship between the response to bintrafusp alfa and plasma Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) level(From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years)
- Time to Response (TTR)(From the date of screening to first radiographically documented tumor response according to RECIST 1.1, assessed up to 2 years)
- Objective Response Rate (ORR)(From the date of screening to radiographically documented progression according to irRECIST, assessed up to 2 years)
- Duration of Response (DOR) evaluation(From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years)
- Quality of Life (QoL)(Every 12 weeks from the date of screening in the first year of study enrolment)
研究者
Dr. Chi-Leung Chiang
Clinical Assistant Professor
The University of Hong Kong
研究点 (1)
Loading locations...
相似试验
终止
2 期
Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell CarcinomaSquamous Cell Carcinoma of Head and NeckNCT04428047UNICANCER7
终止
2 期
Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung CancerStage IVB Lung Cancer AJCC v8Unresectable Lung Non-Squamous Non-Small Cell CarcinomaLocally Advanced Lung Non-Squamous Non-Small Cell CarcinomaMetastatic Lung Non-Squamous Non-Small Cell CarcinomaStage III Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8NCT04971187M.D. Anderson Cancer Center3
已完成
2 期
Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical CancerUterine Cervical NeoplasmsNCT04246489EMD Serono Research & Development Institute, Inc.146
进行中（未招募）
1 期
A phase II trial assessing Bintrafusp alfa, a bifunctional fusion protein targeting TGF-ß and PD-L1, in a pre-operative setting for resectable and untreated head and neck squamous cell carcinomaEUCTR2019-004052-11-FRICANCER59
终止
2 期
Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast CancerTriple Negative Breast NeoplasmsNCT04489940EMD Serono Research & Development Institute, Inc.11