Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Center Hospital East
About this trial
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 criteria
Qualifiers
Written informed consent obtained.
Age ≥ 18 years.
Histologically confirmed olfactory neuroblastoma.
Not eligible for curative local therapy (surgery/radiation).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nivolumab
Treatment groups
14 Participants
are divided into 1 treatment groupSponsors and collaborators
National Cancer Center Hospital East
Lead sponsor
Japan Research Foundation for Clinical Pharmacology
Collaborator
Source ClinicalTrials.gov