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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Nivolumab
Drug240 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.
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: Nivolumab monotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, assessed up to 3 years.Secondary outcomes
1
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.
Time frame
Through study completion, assessed up to 3 years.2
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.
Time frame
Through study completion, assessed up to 3 years.3
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.
Time frame
Through study completion, assessed up to 3 years.4
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.
Time frame
From enrollment to the end of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center Hospital East
Lead sponsor
Japan Research Foundation for Clinical Pharmacology
Collaborator
Source ClinicalTrials.gov