drugset
drugset / Trial / NCT04981899

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

NCT04981899 ↗

Phase 1/2 Active not recruiting 30 enrolled St. Petersburg State Pavlov Medical University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-03-01
Primary completion
2026-05-01
Completion
2026-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 800 mg —
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Ifosfamide Small molecule 5000 mg/m2 —
Subject Nivolumab Monoclonal antibody 40 mg —

Indications

Hodgkins lymphoma