Actively Recruiting
Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab
Led by National Cancer Center Hospital East · Updated on 2025-08-03
14
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center Hospital East
Lead Sponsor
J
Japan Research Foundation for Clinical Pharmacology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Age 18 years or older
- Histologically confirmed olfactory neuroblastoma
- Not eligible for curative local therapy such as surgery or radiation
- Confirmation of recurrent or metastatic disease by biopsy or PET-CT
- Disease progression after prior chemotherapy
- ECOG Performance Status of 0 or 1
- Expected survival of at least 3 months
- At least one measurable tumor lesion per RECIST v1.1
- Adequate organ function with specific blood count and chemistry thresholds
- Female participants agree to use contraception and avoid breastfeeding during and for 5 months after treatment; male participants agree to use contraception during and for 7 months after treatment
You will not qualify if you...
- Active progressive multiple primary cancers within 5 years, except certain curable early cancers
- Ongoing systemic infections requiring treatment
- Infection with HIV or AIDS-related diseases
- Active autoimmune disease needing systemic therapy
- Interstitial lung disease
- Pregnant or breastfeeding
- Any condition deemed inappropriate for the study treatment by the attending physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
2
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan, 329-0498
Actively Recruiting
Research Team
Y
Yuta Hoshi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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