RecruitingPhase 2NCT07100704

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.


Sponsor

National Cancer Center Hospital East

Enrollment

14 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing nivolumab — an immune checkpoint immunotherapy drug — for people with olfactory neuroblastoma (a rare cancer that starts in the nerve cells lining the nasal cavity) that has come back or spread after prior chemotherapy and cannot be treated with surgery or radiation. **You may be eligible if...** - You are 18 or older - You have confirmed olfactory neuroblastoma - Your cancer has returned or spread and cannot be treated with surgery or radiation - You have already received chemotherapy and your cancer has progressed - You have at least one measurable tumor on scans - Your general health is good (ECOG 0–1) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have another active primary cancer - You have a systemic infection requiring treatment - You are known to have HIV or AIDS - You have active autoimmune disease requiring systemic treatment - You have interstitial lung disease (lung scarring) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

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.


Locations(2)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

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NCT07100704