NCT04736810已完成2 期
A Phase II Study of Penpulimab Combined With Chemotherapy ± Anlotinib Hydrochloride in Patients With Advanced Nasopharyngeal Carcinoma
Akeso1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年2月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a multi-center, randomized, open-label, phase II study to evaluate the efficacy and safety of anti-PD-1 antibody Penpulimab (AK105) combined with chemotherapy ± anlotinib hydrochloride in the first-line treatment of patients with advanced nasopharyngeal 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent form voluntarily.
- •Age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
- •Eastern Cooperative Oncology Group (ECOG) performance score 0 or
- •Expected life expectance ≥ 3 months.
- •Histologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
- •Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy.
- •At least one measurable tumor lesion per RECIST 1.1 criteria.
- •Subjects must provide an available tumor tissue sample taken within 3 years prior to enrollment.
- •Adequate organ function.
- •Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception.
- •Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
排除标准
- •Other invasive malignancies within 2 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
- •Is currently participating in a study of an investigational agent or using an investigational device.
- •Has known active central nervous system (CNS) metastases.
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study.
- •Has an active infection requiring systemic therapy.
- •Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- •History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment.
- •Has undergone major surgery within 30 days of Study Day
- •Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- •Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
研究组 & 干预措施
AK105 plus Gemcitabine and Anlotinib Hydrochloride
Experimental
干预措施: AK105 (Biological)
AK105 plus Gemcitabine and Anlotinib Hydrochloride
Experimental
干预措施: Cisplatin (Drug)
AK105 plus Gemcitabine and Anlotinib Hydrochloride
Experimental
干预措施: Gemcitabine (Drug)
AK105 plus Gemcitabine and Anlotinib Hydrochloride
Experimental
干预措施: Anlotinib hydrochloride (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: up to 2 years
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
次要结局
- Disease control rate (DCR)(up to 2 years)
- Progression-free survival (PFS)(up to 2 years)
- Duration of response (DoR)(up to 2 years)
- Overall survival (OS)(up to 2 years)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK105 through 90 days after last dose of AK105.)
- Observed concentrations of AK105(From first dose of AK105 through 90 days after last dose of AK105.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCCHead and Neck Squamous Cell CarcinomaNCT06081673Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University72
招募中
2 期
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic CancerPancreatic Adenocarcinoma MetastaticNCT06051851The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School177
尚未招募
2 期
Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)Resectable Locally Advanced Non-small Cell Lung CancerNCT04846634Tianjin Medical University Cancer Institute and Hospital90
进行中（未招募）
2 期
Study of Pembrolizumab in Locally Advanced Esophageal AdenocarcinomaEsophageal AdenocarcinomaNCT02998268Weill Medical College of Cornell University42
进行中（未招募）
2 期
Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNeoadjuvant TherapiesNCT06165380Li Zhang43