NCT07100704招募中2 期
A Phase II Clinical Trial Evaluating the Efficacy and Safety of Nivolumab Monotherapy for Incurable Recurrent or Metastatic Olfactory Neuroblastoma.
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Objective Response Rate
研究概览
简要总结
This trial evaluates the efficacy and safety of nivolumab monotherapy in patients with recurrent or metastatic olfactory neuroblastoma that is difficult to treat with curative intent. Specifically, nivolumab 240 mg will be administered on Day 1 and Day 15 of each cycle, or nivolumab 480 mg will be administered on Day 1 of each cycle, and this will be continued until disease progression. One cycle is 28 days. The decision on which treatment to administer will be made through consultation between the participant in this trial and their attending physician.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained.
- •Age ≥ 18 years.
- •Histologically confirmed olfactory neuroblastoma.
- •Not eligible for curative local therapy (surgery/radiation).
- •Histological confirmation from recurrent/metastatic lesion or PET-CT evidence.
- •Disease progression after prior chemotherapy.
- •ECOG Performance Status 0-
- •Expected survival ≥ 3 months.
- •At least one measurable lesion per RECIST v1.
- •Adequate organ function; (1) Absolute Neutrophil Count ≥ 1,000/mm³ (2) Hemoglobin ≥ 8.0 g/dL (3) Platelets ≥ 75,000/mm³ (4) Total bilirubin ≤ 1.5×ULN (≤3.0×ULN for constitutional hyperbilirubinemia) (5) AST/ALT ≤ 3×ULN (≤5×ULN with liver metastasis) (6) Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 40 mL/min
- •If the participant is female, she agrees to use contraception and refrain from breastfeeding during the treatment and for 5 months after the treatment. If the participant is male, he agrees to use contraception during the treatment and for 7 months after the treatment.
排除标准
- •Active progressive multiple primary cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years or less. However, lesions equivalent to carcinoma in situ or mucosal cancer that are considered curable by local treatment are not included as multiple primary cancers. Additionally, this may not apply if the attending physician determines that early-stage cancer will not be a prognostic factor.).
- •Has a systemic infection that requires treatment.
- •It has been determined that one is infected with HIV or AIDS-related diseases.
- •Having an active autoimmune disease that required systemic therapy.
- •Having interstitial lung disease.
- •Pregnant or breastfeeding.
- •Any other cases where the attending physician determines that the treatment in this protocol is inappropriate.
研究组 & 干预措施
Nivolumab monotherapy
Experimental
干预措施: Nivolumab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Through study completion, assessed up to 3 years.
Based on the judgment by the Investigator or Sub-investigator, according to the Response evaluation criteria in solid tumors (RECIST) guideline version 1.1. The proportion of participants who complete response (CR) or partial response (PR) will be confirmed for overall response according to RECIST version 1.1.
次要结局
- Clinical Benefit Duration(From enrollment to the end of treatment)
- Duration of Response(Through study completion, assessed up to 3 years.)
- Best Overall Response(Through study completion, assessed up to 3 years.)
- Clinical Benefit Rate(Through study completion, assessed up to 3 years.)
- Disease Control Rate(Through study completion, assessed up to 3 years.)
- Progression-Free Survival(From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.)
- Overall Survival(From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.)
- Adverse Event incidence(Through study completion, assessed up to 3 years)
研究者
研究点 (2)
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