NCT07100704RecruitingPhase 2
Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab
A Phase II Clinical Trial Evaluating the Efficacy and Safety of Nivolumab Monotherapy for Incurable Recurrent or Metastatic Olfactory Neuroblastoma.
Source: ClinicalTrials.gov · Last updated 3 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 10 Jul 2025
- Start date
- 15 Apr 2025
- Primary completion date
- 14 Apr 2028
- Lead sponsor
- National Cancer Center Hospital East
- Diseases
- Neuroblastoma
- NCT number
- NCT07100704
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 14
- From 15 Apr 2025 to the primary completion date, 14 Apr 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnant or breastfeeding.
- Any other cases where the attending physician determines that the treatment in this protocol is inappropriate.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Jichi Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuke | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.