Trial results for a Phase 3 study (NCT03907488) investigating nivolumab or brentuximab vedotin plus combination chemotherapy in newly diagnosed Stage III-IV classic Hodgkin lymphoma were posted on ClinicalTrials.gov on 2025-06-12. The primary analysis of Progression Free Survival (PFS) showed a significant difference between the treatment arms with a p-value of 0.005.
Background
This study investigated immunotherapy drugs, nivolumab or brentuximab vedotin, in combination with chemotherapy and radiation for treating patients with newly diagnosed Stage III-IV classic Hodgkin lymphoma.
Trial design
The study (NCT03907488) was a Phase 3 trial that enrolled 994 participants. It compared two treatment arms for patients with newly diagnosed Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma, Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma, Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma, and Ann Arbor Stage IV Hodgkin Lymphoma. Arm I received chemotherapy, nivolumab, and radiation, while Arm II received chemotherapy, brentuximab vedotin, and radiation.
Key results
Results for key outcomes were posted. For Progression Free Survival (PFS), 41 Participants in Arm I (Chemotherapy, Nivolumab, Radiation) experienced an event, compared to 81 Participants in Arm II (Chemotherapy, Brentuximab Vedotin, Radiation). For Overall Survival, 7 Participants in Arm I experienced an event, versus 14 Participants in Arm II. Event-free Survival (EFS) showed 52 Participants with events in Arm I and 91 Participants in Arm II.
A primary analysis of PFS, utilizing a stratified log rank test, reported a p-value of 0.005, indicating a statistically significant difference between the treatment arms.
Regarding adverse events, Arm I (Chemotherapy, Nivolumab, Radiation) reported 1 Participant, 61 Participants, and 2 Participants for different adverse event counts. Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) reported 3 Participants, 110 Participants, and 3 Participants for the same adverse event counts.
What this means
The posted results suggest that the regimen including nivolumab, chemotherapy, and radiation may lead to improved outcomes in terms of Progression Free Survival, Overall Survival, and Event-free Survival compared to the regimen including brentuximab vedotin, chemotherapy, and radiation in patients with newly diagnosed Stage III-IV classic Hodgkin lymphoma. The statistically significant p-value of 0.005 for PFS supports a notable difference between the two treatment approaches.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03907488, titled "Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma," were posted on 2025-06-12 on clinicaltrials.gov.