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

NCT07100704 | Recruiting Phase 2

• 2 other identifiers: OrionjRCT1031240654
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Recurrent/ Metastatic Olfactory Neuroblastoma

Keywords

Recurrent/ Metastatic Olfactory Neuroblastoma; Nivolumab

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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.

  Through study completion, assessed up to 3 years.

Secondary Outcomes (8)

• 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.

• Clinical Benefit Duration

  From enrollment to the end of treatment

• Disease Control Rate

  Through study completion, assessed up to 3 years.

Study Arms (1)

Nivolumab monotherapy

EXPERIMENTAL

Drug: Nivolumab

Interventions

Nivolumab DRUG

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.

Nivolumab monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center Hospital East: lead
• Japan Research Foundation for Clinical Pharmacology: collaborator

Study Sites (2)

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

RECRUITING

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yuta Hoshi, MD

CONTACT

+81-4-7133-1111; yuhosh@east.ncc.go.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The decision on which treatment to administer will be made through consultation between the participant in this trial and their attending physician.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 3, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): April 14, 2028
• Study Completion (Estimated): October 14, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)