Finding studies
Finding studies
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Lead
Mayo Clinic
With
PRIMARY OBJECTIVES: I. To assess the clinical benefit of nivolumab in T-cell lymphomas, as measured by objective response rate (ORR) within 12 cycles according to the Lugano Classification Response Criteria (2014). SECONDARY OBJECTIVES: I. To assess safety and tolerability of the regimen in this patient population. II. To assess progression-free survival (PFS). III. To assess duration of response (DOR). IV. To assess overall survival (OS). TERTIARY OBJECTIVES: I. To evaluate T-cell/cytokine profile in the peripheral blood - peripheral blood specimens will be used to assess T-cell activation and cytokine up regulation as measures of treatment effect. II. To evaluate intratumoral biomarkers- intratumoral cell populations and distribution, genetic variability, mutational burden and T-cell activation will be evaluated to identify potential biomarkers that correlate with response to therapy. III. To assess the potential association between PD-L1/PD-1/PD-L2 expression on tumor and T-cells and/or PD-L1 soluble levels in plasma with clinical efficacy of PD-1 blockade. OUTLINE: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive nivolumab IV over 60 minutes on day 1 of course 9. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 35 days, 100-120 days, 230-250 days, and 330-390 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
