A Phase II Study of Nivolumab in Combination with Radiation Therapy as Definitive Treatment for Patients with Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.
- Conditions
- Neoplasms
- Registration Number
- KCT0004049
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 26
?Age = 19 years
?Histologically or cytologically confirmed mucosal melanoma of head and neck
?Locally advanced and unresectable
?No previous chemotherapy for purpose of palliation
?ECOG performance status of 0~2
?Measurable lesion per RECIST 1.1 criteria
?Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status. Repeat samples may be required if adequate tissue is not provided. Newly obtained endoscopic biopsy specimens are preferred to archived samples and formalin-fixed, paraffin-embedded (FFPE) block specimens are preferred to slides.
?Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
?Collection of an archived tissue sample will also be requested (where available) to support evaluation of the clinical utility of biomarker assessment in newly obtained vs. archived tissue samples; however, a subject will not be precluded from participating in the study if an archived tissue sample is not available for collection or is otherwise insufficient for analysis.
?Adequate marrow, hepatic, renal and cardiac functions:
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy
Total serum bilirubin = 1.5 x ULN
Absolute neutrophil count (ANC) = 1,500/uL
Platelets = 100,000/uL
Hemoglobin = 8.0 g/dL
?Adequate renal function: Serum creatinine = 1.5 x UNL (upper normal limit)
?provision of a signed written informed consent
?Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
?Active or history of autoimmune disease or immune deficiency, including MG, myositis, hepatitis, SLE, RA, IBD or GBS)
?Severe co-morbid illness and/or active infections
?Pregnant or lactating women
?History of documented congestive heart failure; angina pectoris requiring medication; evidence of tranasmural myocardial infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; or high risk of uncontrollable arrhythmia
?Active CNS metastases not controllable with radiotherapy or corticosteroids
(however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
?Must not have undergone a major surgical procedure < 4 weeks or radiotherapy <2 weeks prior to D1 of treatment
?Administration of a live, attenuated vaccine within 4 weeks before study treatment
?Treatment with systemic immunosuppressive medication (including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks prior to D1 of treatment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method determine the response rate((Response rate of combined treatment with nobilvir and radiation therapy by IrRECIST)
- Secondary Outcome Measures
Name Time Method clinical adverse events (Clinical Adverse Reactions and Clinical Laboratory Parameters)