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A Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Sponsor: St. Petersburg State Pavlov Medical University
Summary
Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of Nivo combined with ICE as first salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the fixed dose of 40 mg in combination with ifosfamide, carboplatin, and etoposide (NICE-40) in patients with relapsed/refractory Hodgkin Lymphoma.
Official title: Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2021-03-01
Completion Date
2026-09-15
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Nivolumab
6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40.
Ifosfamide
5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.
Carboplatin
Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.
Etoposide
100 mg / m2 intravenously on 1-3 days of the NICE-40.
Locations (3)
National Medicine Research Center of oncology named after N.N. Petrov
Saint Petersburg, Pesochny, Russia
Irkutsk Regional Cancer Center
Irkutsk, Russia
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia