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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT1031240654 | Other Identifier | Ministry of Health, Labour and Welfare |
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| Name | Class |
|---|---|
| Japan Research Foundation for Clinical Pharmacology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab monotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, assessed up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, assessed up to 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuta Hoshi, MD | Contact | +81-4-7133-1111 | yuhosh@east.ncc.go.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital East | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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The decision on which treatment to administer will be made through consultation between the participant in this trial and their attending physician.
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|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | Through study completion, assessed up to 3 years |
| Jichi Medical University Hospital | Recruiting | Shimotsuke | Tochigi | 329-0498 | Japan |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |