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
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
- 2023-10-01
- Completion
- 2024-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |