Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab

Phase 2RecruitingNCT07100704

National Cancer Center Hospital East14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent/ Metastatic Olfactory Neuroblastoma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consent obtained. 2. Age ≥ 18 years. 3. Histologically confirmed olfactory neuroblastoma. 4. Not eligible for curative local therapy (surgery/radiation). 5. Histological confirmation from recurrent/metastatic lesion or PET-CT evidence. 6. Disease progression after prior chemotherapy. 7. ECOG Performance Status 0-1. 8. Expected survival ≥ 3 months. 9. At least one measurable lesion per RECIST v1.1. 10. 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 11. 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. Exclusion Criteria: 1. 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.). 2. Has a systemic infection that requires treatment. 3. It has been determined that one is infected with HIV or AIDS-related diseases. 4. Having an active autoimmune disease that required systemic therapy. 5. Having interstitial lung disease. 6. Pregnant or breastfeeding. 7. Any other cases where the attending physician determines that the treatment in this protocol is inappropriate.

Outcomes

Primary Outcomes

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.