Trial results for a Phase 2 study investigating nivolumab in combination with brentuximab vedotin for relapsed or refractory CD30+ lymphoma were posted on ClinicalTrials.gov on 2026-05-12. The combination arm showed an overall response rate in 7 participants, compared to 1 participant in the brentuximab vedotin monotherapy arm.
Background
The Phase 2 pilot trial investigated brentuximab vedotin with or without nivolumab in treating patients with CD30+ lymphoma that had relapsed or was refractory to previous treatments. This included patients with Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, and Refractory Non-Hodgkin Lymphoma. The study aimed to assess if combining these therapies could improve outcomes in this patient population. Biological therapies, such as brentuximab vedotin, may stimulate the immune system and stop cancer cells from growing, while monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.
Trial design
The Phase 2 pilot study (NCT01703949) enrolled 28 participants with relapsed or refractory CD30+ lymphoma, including Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, and Refractory Non-Hodgkin Lymphoma. The trial evaluated two treatment arms: Arm A, which received brentuximab vedotin, and Arm B, which received brentuximab vedotin in combination with nivolumab. The study's objective was to determine the overall response rate as measured by the Cheson 2007 Criteria.
Key results
The trial evaluated the Overall Response Rate as measured by the Cheson 2007 Criteria:
- In Arm A (Brentuximab Vedotin), the overall response rate was observed in 1 participant.
- In Arm B (Brentuximab Vedotin, Nivolumab), the overall response rate was observed in 7 participants.
What this means
The results from this Phase 2 pilot trial suggest that the combination of brentuximab vedotin and nivolumab may lead to a higher overall response rate compared to brentuximab vedotin monotherapy in patients with relapsed or refractory CD30+ lymphoma. With 7 participants responding in the combination arm versus 1 participant in the monotherapy arm, these findings could support further investigation into this dual-agent regimen for this challenging patient population. The study's enrollment of 28 participants indicates that these are preliminary findings, and larger trials would be needed to confirm efficacy and safety.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT01703949, titled "Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma", were posted on 2026-05-12 on clinicaltrials.gov.