NCT04974398进行中（未招募）3 期
A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
Akeso56 个研究点 分布在 5 个国家目标入组 296 人开始时间: 2021年8月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 296
- 试验地点
- 56
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study is a randomized, double-blind, multi-center phase III clinical study to compare the efficacy and safety of penpulimab combined with chemotherapy and placebo combined with chemotherapy in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed written Informed Consent Form(ICF).
- •Main study: Age of ≥ 18 years and ≤ 75 years at the time of enrollment.
- •Substudy: Age of ≥ 12 years and < 18 years. Weight≥ 35KG.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Expected survival of ≥ 3 months.
- •Histologically or cytologically confirmed nasopharyngeal carcinoma.
- •Subjects with primary metastatic (nasopharyngeal carcinoma, stage IVB defined by the Union for International Cancer Control and the American Joint Committee on Cancer Staging System edition 8) nasopharyngeal carcinoma who are not suitable for local treatment or radical treatment; subjects who have a local-regional recurrence and/or distant metastasis more than 6 months after the completion of prior radical treatment (radiotherapy with induction, concurrent, adjuvant chemotherapy)； No systemic treatment has been received for recurrent or metastatic diseases, not amendable to local treatment or have received local treatment for the local-regional recurrent disease
- •At least one measurable lesion according to RECIST v1.1;
- •Has adequate organ function.
- •All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 150 days after the last dose of study treatment.
排除标准
- •Subjects with pathologically diagnosed nasopharyngeal adenocarcinoma or sarcoma.
- •Subjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded.
- •Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.
- •Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism.
- •Active autoimmune disease requiring systemic treatment within 2 years prior to initial administration, or as an autoimmune disease that can recur or for which treatment is planned determined by the investigator.
- •Active or past history of definite inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
- •History of immunodeficiency; those who test positive for HIV antibody; current chronic use of systemic corticosteroids or immunosuppressive agents.
- •Known active tuberculosis (TB) (suspected of having active TB need to undergo clinical examination for exclusion of such possibility); known active syphilis infection.
- •Known history of allotransplantation and allogeneic hematopoietic stem cell transplantation.
- •Has known active Hepatitis B or Hepatitis C.
- •Active or untreated CNS metastases.
- •Subjects with peripheral neuropathy.
- •Unresolved toxicity from prior anti-tumor therapy, defined as toxicity that has not recovered .
- •Received a live vaccine within 30 days before the first dose or planned to receive a live vaccine during the study.
- •Known allergy to any study drug component; known history of serious hypersensitivity to other monoclonal antibodies.
- •Pregnant or nursing (lactating) women.
研究组 & 干预措施
Group A
Experimental
Group A (study group): Penpulimab plus cisplatin/carboplatin and gemcitabine
干预措施: Penpulimab (Drug)
Group B
Placebo Comparator
Group B (control group): Placebo plus cisplatin/carboplatin and gemcitabine
干预措施: placebo (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to 2 years
PFS assessed by BIRC based on RECIST v1.1 .
次要结局
- Duration of response (DoR)(Up to 2 years)
- PD-L1 expression(Baseline (Tumor tissue samples must be provided to the research center or central laboratory prior to initial administration).)
- Disease control rate (DCR)(Up to 2 years)
- Maximum observed concentration (Cmax)(From first dose of penpulimab through 30 days after last dose of penpulimab)
- Blood EBV level(Up to 2 years)
- Overall survival(OS)(Up to 4 years)
- Objective response rate (ORR)(Up to 2 years)
- Adverse event (AE)(From the time of informed consent signed through 90 days after the last dose of penpulimab)
- Anti-drug antibodies (ADA)(From first dose of penpulimab through 30 days after last dose of penpulimab)
研究者
研究点 (56)
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