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

JRCT ID: jRCT1031240654

Registered date:03/02/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Recurrent/metastatic olfactory neuroblastoma
• Date of first enrollment: 15/04/2025
• Target sample size: 14
• Study type: Interventional
• Intervention(s): Chemotherapy with Nivolumab

Outcome(s)

• Primary Outcome: Objective response rate
• Secondary Outcome: Progression free survival, Overall survival, Duration of response, Best overall response, Disease specific rate, Clinical benefit rate, Clinical benefit duration, Occurrence of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have provided written informed consent.
2) Patients aged 18 years or older.
3) Patients diagnosed with olfactory neuroblastoma histologically.
4) Patients for whom radical local treatments such as surgery or radiation are not indicated.
5) Patients with a histological diagnosis of olfactory neuroblastoma taken from local recurrent or distant metastatic lesions. If histological diagnosis is difficult, patients must show uptake in the recurrent or metastatic lesion on PET-CT.
6) Patients who showed an increase in the size of their lesions after chemotherapy for olfactory neuroblastoma
7) Patients with an ECOG performance status (PS) of 0-1.
8) Patients expected to survive for at least 3 months.
9) Patients with one or more measurable lesions based on RECIST version 1.1.
If a lesion with a history of local treatment (radiation therapy, etc.) is to be measured, it can only be selected as a target lesion if the lesion has worsened.
10) Patients meeting the following organ function criteria at baseline examination: 1, Neutrophil count >= 1,000/mm3 2, Hemoglobin >= 8.0 g/dL 3, Platelet count >= 75,000/mm3 4, Total bilirubin <= 1.5 times the institutional upper limit of normal (<= 3.0 times in case of hereditary jaundice) 5, AST/ALT <= 3 times the institutional upper limit of normal (<= 5 times in case of liver metastases) 6, Serum creatinine is less than 1.5 times the upper limit of normal or creatinine clearance is 40 mL/min or more.
11) For female patients, those who agree to use an appropriate method of contraception during the study period and for 5 months after the administration has ended, and also agree not to breastfeed during the study period and for 5 months after administration has ended.
12) For male patients, those who agree to use appropriate contraception during the study period and for 7 months after the administration has ended.

Exclude criteria

1) Patients with active advanced multiple cancers. (Synchronous multiple cancers or metachronous multiple cancers with disease free interval of less than 5 years. However, lesions that are considered cured due to local treatment, such as in situ cancer or equivalent mucosal cancer, are not included as multiple cancers. Additionally, this does not apply if the attending physician determines that an early-stage cancer is not a prognostic factor.)
2) Patients with systemic infections that require treatment
3) Patients known to be infected with HIV or AIDS related disease.
4) Patients with active autoimmune disease that require systemic therapy
5) Patients with interstitial pneumonia
6) Patients who are pregnant or breastfeeding
7) Any other patients deemed unsuitable for this protocol's treatment by the attending physician.

Related Information

• Primary Sponsor: Tahara Makoto
• Source(s) of Monetary Support: Japan Research Foundation for Clinical Pharmacology