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Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab

NCT07100704 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-08-03

No results posted yet for this study

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.

Conditions

  • Recurrent/ Metastatic Olfactory Neuroblastoma

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.

Sponsors & Collaborators

  • Japan Research Foundation for Clinical Pharmacology

    collaborator UNKNOWN

  • National Cancer Center Hospital East

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2028-04-14
Completion
2028-10-14

Countries

  • Japan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100704 on ClinicalTrials.gov