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

Not Applicable

Recruiting

• Conditions: Recurrent/ Metastatic Olfactory Neuroblastoma
• Interventions: Drug: Nivolumab

• Registration Number: NCT07100704
• Lead Sponsor: National Cancer Center Hospital East

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-15
• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-27
• Last Update Submitted: 2025-07-27
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Primary Completion: 2028-04-14
• Study Completion: 2028-10-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab monotherapy	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	Through study completion, assessed up to 3 years.	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Benefit Duration	From enrollment to the end of treatment	This is for participants who achieved the best overall response of CR or PR according to the RECIST version. 1.1, or who maintained SD for 24 weeks or longer, the period from the date of official registration (treatment initiation date) to the earliest date of determined disease progression, date of death due to any cause, or the end date of the clinical trial period.
Duration of Response	Through study completion, assessed up to 3 years.	The period from when CR or PR was first confirmed in the overall effect, according to the RECIST version. 1.1, to the earlier date when progression (PD based on imaging diagnosis) was determined or the date of death due to any cause.
Best Overall Response	Through study completion, assessed up to 3 years.	The best overall response (BOR) is determined based on RECIST ver. 1.1, recorded from the start of protocol treatment. The determination of CR (Complete Response) and PR (Partial Response) shall be confirmed by the subsequent evaluation conducted at least 4 weeks after the criteria are first met.
Clinical Benefit Rate	Through study completion, assessed up to 3 years.	The proportion of participants who achieved a best overall response of CR or PR according to RECIST version 1.1, or who maintained SD for 24 weeks or longer.
Disease Control Rate	Through study completion, assessed up to 3 years.	The proportion of participants who achieved the best overall response of CR or PR according to RECIST version. 1.1, or who maintained SD for 6 weeks or longer.
Progression-Free Survival	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.	The period from the registration date as the starting point to the earlier of the date deemed as progression or the date of death due to any cause.
Overall Survival	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.	The period from the registration date as the starting point until the date of death due to any cause. The last confirmed survival date is considered the cut-off point for surviving participants. For participants that become untraceable, the last date on which survival was confirmed before losing track is considered the cut-off point.
Adverse Event incidence	Through study completion, assessed up to 3 years	Summarize and analyze the incidence and severity of adverse events. Evaluate the worst grade throughout all courses using CTCAE version. 5.0.

Trial Locations

Locations (2)

National Cancer Center Hospital East; 🇯🇵 Kashiwa, Chiba, Japan

Jichi Medical University Hospital; 🇯🇵 Shimotsuke, Tochigi, Japan