Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab

Официальное название

A Phase II Clinical Trial Evaluating the Efficacy and Safety of Nivolumab Monotherapy for Incurable Recurrent or Metastatic Olfactory Neuroblastoma.

Обзор

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.

Вмешательства

• Препарат Nivolumab
  240 mg will be administered on Day 1 and Day 15 of each cycle, or 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 the site principal investigator or site co-investigator.

Первичные конечные точки

• Objective Response Rate [Срок оценки: Through study completion, assessed up to 3 years.]

Вторичные конечные точки (8)

• Duration of Response [Срок оценки: Through study completion, assessed up to 3 years.]
• Best Overall Response [Срок оценки: Through study completion, assessed up to 3 years.]
• Clinical Benefit Rate [Срок оценки: Through study completion, assessed up to 3 years.]
• Clinical Benefit Duration [Срок оценки: From enrollment to the end of treatment]
• Disease Control Rate [Срок оценки: Through study completion, assessed up to 3 years.]
• Progression-Free Survival [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Through study completion, assessed up to 3 years]

Критерии участия

Критерии включения

• 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 0-1.
• Expected survival ≥ 3 months.
• At least one measurable lesion per RECIST v1.1.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Япония · 2 центра

• National Cancer Center Hospital East — Kashiwa
• Jichi Medical University Hospital — Shimotsuke

Идентификаторы

NCT: NCT07100704 · Orion · jRCT1031240654

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗