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Tests treatment safety and results for Recurrent/ Metastatic Olfactory Neuroblastoma
Official title Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab
ClinicalTrials.gov ID: NCT07100704
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, being studied as a potential treatment for recurrent/ metastatic olfactory neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Active progressive multiple primary cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kashiwa, Chiba, Japan
- Shimotsuke, Tochigi, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kashiwa, Chiba, Japan; Shimotsuke, Tochigi, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.