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NCT Number: NCT07100704

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

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.

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Key information

Conditions

Recurrent/ Metastatic Olfactory Neuroblastoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Objective Response Rate

    Time frame: 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 outcomes

  1. Duration of Response

    Time frame: 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.

  2. Best Overall Response

    Time frame: 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.

  3. Clinical Benefit Rate

    Time frame: 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.

  4. Clinical Benefit Duration

    Time frame: 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.

  5. Disease Control Rate

    Time frame: 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.

  6. Progression-Free Survival

    Time frame: 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.

  7. Overall Survival

    Time frame: 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.

  8. Adverse Event incidence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuta Hoshi, MD

CONTACT

[email protected]

+81-4-7133-1111

Sponsors and collaborators

Lead sponsor

National Cancer Center Hospital East

Other

Collaborators

  • Japan Research Foundation for Clinical Pharmacology

Registry information

Official study title

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

Acronym: Orion

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.