This is a pilot study investigating the role of nivolumab, a PD-1 inhibitor, in the treatment of advanced stage or relapsed/refractory NKTL. Patients who have received PD-1 inhibitors will be excluded from this study. Patients who have a complete response or good partial response to nivolumab during initial phase will continue to be treated with nivolumab. Patients who have a partial response, stable disease, and progressive disease to nivolumab during initial phase will be treated with the combination of nivolumab and GDP/L-asparaginase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
240mg every 2 weeks.
Initial treatment dose is 240mg every 2 weeks for 4 doses. Dose changes to 360mg every 3 weeks when given with GDP/L-aspa. Maintenance treatment dose is 240mg every 2 weeks.
800mg/m2 on Days 1 and 8 every 21 days
National Cancer Centre Singapore
Singapore, Singapore
Number of patients with complete response and partial response to treatment
To calculate best overall response rate
Time frame: 6 months after the start of treatment
Number of incidences of grade 3-5 non-haematological adverse events
To calculate the toxicity rate of the treatment
Time frame: From start of first treatment to 100 days after last treatment dose
Progression-free survival
Time frame: From start of treatment to date of disease progression or death, up to 2.5 years
Overall survival
Time frame: From the start of treatment to date of death from any cause, up to 2.5 years
Number of patients with complete response and partial response to single agent nivolumab
To calculate the overall response rate of single agent nivolumab
Time frame: 6 months after the start of treatment
Number of patients with complete response and partial response to nivolumab in combination with GDP/L-asparaginase
Time frame: 6 months after the start of treatment
Number of incidences of adverse events
To calculate the rate of adverse events from nivolumab with or without GDP/L-asparaginase
Time frame: From start of first treatment to 100 days after last treatment dose
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20mg/m2 on Day 1 to 4 every 21 days
10mg on Days 1 to 4 every 21 days
6000 Units/m2 on Days 2 to 8 every 21 days