Recurrent/ Metastatic Olfactory NeuroblastomaPhase 2OrionNCT07100704
Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab
A Phase 2 study testing Nivolumab in people with Recurrent/ Metastatic Olfactory Neuroblastoma, run by National Cancer Center Hospital East at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent/ Metastatic Olfactory Neuroblastoma
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesJapan
- Study dates
- 15 Apr 2025to 14 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 (≤5×ULN with liver metastasis) (6) Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 40 mL/min
- 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 the treatment and for 7 months after the treatment.
Who cannot join
- 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.
- Having interstitial lung disease.
- Pregnant or breastfeeding.
- Any other cases where the attending physician determines that the treatment in this protocol is inappropriate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Yuta Hoshi, MD, +81-4-7133-1111
Makoto Tahara, MD, PhD
- Recruiting
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
Takahiro Fukuhara, MD, PhD
Takahiro Fukuhara, MD, PhD
About this study
Official title: A Phase II Clinical Trial Evaluating the Efficacy and Safety of Nivolumab Monotherapy for Incurable Recurrent or Metastatic Olfactory Neuroblastoma.
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.
- Being tested
- Nivolumab
- Keywords
- Recurrent/ Metastatic Olfactory Neuroblastoma, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab monotherapy | Experimental | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Based on the judgment by the Investigator or Sub-investigator, according to the Response evaluation criteria in solid tumors (RECIST) guideline version 1.1. The proportion of participants who complete response (CR) or partial response (PR) will be confirmed for overall response according to RECIST version 1.1.
Measured: Through study completion, assessed up to 3 years.
Secondary outcomes (8)
Duration of Response
The period from when CR or PR was first confirmed in the overall effect, according to the RECIST version. 1.1, to the earlier date when progression (PD based on imaging diagnosis) was determined or the date of death due to any cause.
Measured: Through study completion, assessed up to 3 years.
Best Overall Response
The best overall response (BOR) is determined based on RECIST ver. 1.1, recorded from the start of protocol treatment. The determination of CR (Complete Response) and PR (Partial Response) shall be confirmed by the subsequent evaluation conducted at least 4 weeks after the criteria are first met.
Measured: Through study completion, assessed up to 3 years.
Clinical Benefit Rate
The proportion of participants who achieved a best overall response of CR or PR according to RECIST version 1.1, or who maintained SD for 24 weeks or longer.
Measured: Through study completion, assessed up to 3 years.
Clinical Benefit Duration
This is for participants who achieved the best overall response of CR or PR according to the RECIST version. 1.1, or who maintained SD for 24 weeks or longer, the period from the date of official registration (treatment initiation date) to the earliest date of determined disease progression, date of death due to any cause, or the end date of the clinical trial period.
Measured: From enrollment to the end of treatment
Disease Control Rate
The proportion of participants who achieved the best overall response of CR or PR according to RECIST version. 1.1, or who maintained SD for 6 weeks or longer.
Measured: Through study completion, assessed up to 3 years.
Progression-Free Survival
The period from the registration date as the starting point to the earlier of the date deemed as progression or the date of death due to any cause.
Measured: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Overall Survival
The period from the registration date as the starting point until the date of death due to any cause. The last confirmed survival date is considered the cut-off point for surviving participants. For participants that become untraceable, the last date on which survival was confirmed before losing track is considered the cut-off point.
Measured: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Adverse Event incidence
Summarize and analyze the incidence and severity of adverse events. Evaluate the worst grade throughout all courses using CTCAE version. 5.0.
Measured: Through study completion, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start15 Apr 2025
- Primary completion14 Apr 2028 (estimated)
- Study completion14 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/ Metastatic Olfactory NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The decision on which treatment to administer will be made through consultation between the participant in this trial and their attending physician.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Hospital East
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Research Foundation for Clinical Pharmacology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100704
- Sponsor's protocol ID
- Orion
- Other IDs
- jRCT1031240654
- Acronym
- Orion
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Evaluating the Efficacy and Safety of Nivolumab Monotherapy for Incurable Recurrent or Metastatic Olfactory Neuroblastoma.
- ClinicalTrials.gov ID
- NCT07100704
- Acronym / sponsor ID
- Orion / Orion
- Keywords
- Recurrent/ Metastatic Olfactory Neuroblastoma, Nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- National Cancer Center Hospital EastUniversity, hospital or other
- Collaborators
- Japan Research Foundation for Clinical Pharmacology
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 14 Apr 2028 (estimated)
- Study completion
- 14 Oct 2028 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The decision on which treatment to administer will be made through consultation between the participant in this trial and their attending physician.
| Arm | Type | Receives |
|---|---|---|
| Nivolumab monotherapy | Experimental | Drug: Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Having interstitial lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab240 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. | Drug | Nivolumab monotherapy |
Primary outcome
Objective Response Rate
Time frame: Through study completion, assessed up to 3 years.
Based on the judgment by the Investigator or Sub-investigator, according to the Response evaluation criteria in solid tumors (RECIST) guideline version 1.1. The proportion of participants who complete response (CR) or partial response (PR) will be confirmed for overall response according to RECIST version 1.1.
8 secondary outcomes
Duration of Response
Time frame: Through study completion, assessed up to 3 years.
Best Overall Response
Time frame: Through study completion, assessed up to 3 years.
Clinical Benefit Rate
Time frame: Through study completion, assessed up to 3 years.
Clinical Benefit Duration
Time frame: From enrollment to the end of treatment
Disease Control Rate
Time frame: Through study completion, assessed up to 3 years.
Progression-Free Survival
Time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Overall Survival
Time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Adverse Event incidence
Time frame: Through study completion, assessed up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Recurrent/ Metastatic Olfactory Neuroblastoma, run by National Cancer Center Hospital East at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuta Hoshi, MD (+81-4-7133-1111, yuhosh@east.ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Through study completion, assessed up to 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.