Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab (NCT07100704) | Clinical Trial Compass
RecruitingPhase 2
Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab
Japan14 participantsStarted 2025-04-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
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.).
What they're measuring
1
Objective Response Rate
Timeframe: Through study completion, assessed up to 3 years.