Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04230330|
Recruitment Status : Withdrawn (PI has left the institution.)
First Posted : January 18, 2020
Last Update Posted : November 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|NK/T Cell Lymphoma||Drug: IV Nivolumab Drug: IV Gemcitabine Drug: IV Cisplatin Drug: IV/PO Dexamethasone Drug: IV L-asparaginase||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Nivolumab in Combination With GDP (Gemcitabine, Dexamethasone, Cisplatin)/ L-asparaginase in Patients With Advanced Stage or Relapsed/ Refractory Natural-killer/ T-cell Lymphoma|
|Actual Study Start Date :||December 12, 2019|
|Actual Primary Completion Date :||June 12, 2020|
|Actual Study Completion Date :||June 12, 2020|
After 4 doses of nivolumab, if the patient has complete responses (CR) or good partial response (PR), the patient will continue on nivolumab until disease progression, unacceptable toxicities, or discontinuation of treatment. During PET4-directed treatment with single agent nivolumab, if patient has PD, they will proceed to the Nivo+GDP/L-aspa arm.
Drug: IV Nivolumab
240mg every 2 weeks.
Other Name: Opdivo
Experimental: Nivolumab + GDP/ L-asparaginase
After 4 doses of nivolumab, if the patient has PR, stable disease (SD), or progressive disease (PD), the patient will switch to nivolumab-GDP/L-aspa treatment. After 6 cycles of treatment, if CR is achieved, the patient will continue on single agent nivolumab until disease progression, unacceptable toxicities, or discontinuation of treatment.
Drug: IV Nivolumab
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.
Other Name: Opdivo
Drug: IV Gemcitabine
800mg/m2 on Days 1 and 8 every 21 days
Drug: IV Cisplatin
20mg/m2 on Day 1 to 4 every 21 days
Drug: IV/PO Dexamethasone
10mg on Days 1 to 4 every 21 days
Drug: IV L-asparaginase
6000 Units/m2 on Days 2 to 8 every 21 days
- Number of patients with complete response and partial response to treatment [ Time Frame: 6 months after the start of treatment ]To calculate best overall response rate
- Number of incidences of grade 3-5 non-haematological adverse events [ Time Frame: From start of first treatment to 100 days after last treatment dose ]To calculate the toxicity rate of the treatment
- 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 [ Time Frame: 6 months after the start of treatment ]To calculate the overall response rate of single agent nivolumab
- 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 [ Time Frame: From start of first treatment to 100 days after last treatment dose ]To calculate the rate of adverse events from nivolumab with or without GDP/L-asparaginase
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230330
|National Cancer Centre Singapore|
|Principal Investigator:||Tiffany Tang, MD||National Cancer Centre, Singapore|