Nivolumab for recurrent or metastatic olfactory neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open‑label Phase 2 trial gives nivolumab alone to adults with recurrent or metastatic olfactory neuroblastoma who are not candidates for curative surgery or radiotherapy. Patients receive either 240 mg on Days 1 and 15 of each 28‑day cycle or 480 mg on Day 1 of each 28‑day cycle, with the dosing schedule chosen by the participant and their treating physician, and treatment continues until disease progression. Key eligibility includes histologic confirmation of olfactory neuroblastoma, prior progression after chemotherapy, at least one measurable lesion per RECIST v1.1, ECOG performance status 0–1, and adequate organ function. The trial will record tumor response and safety/tolerability outcomes during treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent obtained.
2. Age ≥ 18 years.
3. Histologically confirmed olfactory neuroblastoma.
4. Not eligible for curative local therapy (surgery/radiation).
5. Histological confirmation from recurrent/metastatic lesion or PET-CT evidence.
6. Disease progression after prior chemotherapy.
7. ECOG Performance Status 0-1.
8. Expected survival ≥ 3 months.
9. At least one measurable lesion per RECIST v1.1.
10. 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
11. 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.

Exclusion Criteria:

1. 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.).
2. Has a systemic infection that requires treatment.
3. It has been determined that one is infected with HIV or AIDS-related diseases.
4. Having an active autoimmune disease that required systemic therapy.
5. Having interstitial lung disease.
6. Pregnant or breastfeeding.
7. Any other cases where the attending physician determines that the treatment in this protocol is inappropriate.

Where it's running

• National Cancer Center Hospital East
  Kashiwa, Chiba, Japan Recruiting
• Jichi Medical University Hospital
  Shimotsuke, Tochigi, Japan Recruiting

Study contacts

• Study coordinator: Yuta Hoshi, MD
• Email: yuhosh@east.ncc.go.jp
• Phone: +81-4-7133-1111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.