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

NCT ID: NCT07100704

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2028-10-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nivolumab monotherapy

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Research Foundation for Clinical Pharmacology

UNKNOWN

Sponsor Role: collaborator

National Cancer Center Hospital East

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Site Status: RECRUITING

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yuta Hoshi, MD

Role: CONTACT

yuhosh@east.ncc.go.jp

+81-4-7133-1111

Facility Contacts

Yuta Hoshi, MD

Role: primary

+81-4-7133-1111

Takahiro Fukuhara, MD, PhD

Role: primary

Other Identifiers

jRCT1031240654

Identifier Type: OTHER

Identifier Source: secondary_id

Orion

Identifier Type: -

Identifier Source: org_study_id