Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nivolumab.
- Who it may be relevant to
- Registry conditions: Recurrent/ Metastatic Olfactory Neuroblastoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Clinical Trial Evaluating the Efficacy and Safety of Nivolumab Monotherapy for Incurable Recurrent or Metastatic Olfactory Neuroblastoma.
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Objective Response Rate [Time frame: Through study completion, assessed up to 3 years.]
Secondary outcome measures (8)
- Duration of Response [Time frame: Through study completion, assessed up to 3 years.]
- Best Overall Response [Time frame: Through study completion, assessed up to 3 years.]
- Clinical Benefit Rate [Time frame: Through study completion, assessed up to 3 years.]
- Clinical Benefit Duration [Time frame: From enrollment to the end of treatment]
- Disease Control Rate [Time frame: Through study completion, assessed up to 3 years.]
- 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.]
- 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.]
- Adverse Event incidence [Time frame: Through study completion, assessed up to 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 2 centers
- National Cancer Center Hospital East — Kashiwa
- Jichi Medical University Hospital — Shimotsuke
Identifiers
NCT: NCT07100704 · Orion · jRCT1031240654