Finding studies
Finding studies
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Lead
Vanderbilt-Ingram Cancer Center
PRIMARY OBJECTIVES: I. To assess the objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. SECONDARY OBJECTIVES: I. To assess the progression-free survival (PFS). II. To assess the overall survival (OS). III. To correlate response and mutation load with PD-L1 status (5% and 1% cutoffs). IV. To assess clinical benefit (responses and stable disease lasting \>= 6 months). V. To assess the response rate in mutation-defined subgroups, including subjects with \>= 25 mutations/mutational burden (MB) and \>= 30 mutations/MB. VI. To correlate the type of mutations with response. OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 2 weeks for up to 2 years (104 weeks) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 35 days and then every 3 months for 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
