NCT06984146

Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma

Detailed description

Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.

Conditions

• Hodgkin Lymphoma, Adult

Interventions

Type	Name	Description
DRUG	Nivolumab	40 mg day 1 and 15
DRUG	Doxorubicin	25 mg/m2 day 1 and 15
DRUG	Vinblastine	6 mg/m2 (not exceeding 10 mg) day 1 and 15
DRUG	Dacarbazine	375 mg/m2 day 1 and 15

Timeline

• Start date: 2025-04-15
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2025-05-22
• Last updated: 2025-11-26

Locations

1 site across 1 country: Russia