Trial results for a combination of nivolumab plus brentuximab vedotin in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) were posted on ClinicalTrials.gov on 2025-02-10. The study demonstrated high complete metabolic response rates, with up to 92.9 Percent of participants in one cohort, and overall response rates reaching 96.4 Percent of participants.
Background
Classic Hodgkin lymphoma (cHL) is a type of lymphoma that can be challenging to treat, especially when it is relapsed or refractory to first-line treatment. This study investigated a combination therapy for children, adolescents, and young adults with cHL who had not responded to initial treatments or whose disease had returned.
Trial design
This Phase 2 study (NCT02927769) was completed with an enrollment of 72 participants. The trial focused on patients aged 5 to 30 years old with Hodgkin's lymphoma (cHL) that was relapsed or refractory from first-line treatment. The study evaluated the safety and effectiveness of nivolumab plus brentuximab vedotin, with a subsequent regimen of brentuximab vedotin plus bendamustine for patients with suboptimal response.
Key results
Key efficacy results, assessed by Blinded Independent Centralized Review (BICR), include:
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
- Complete Metabolic Response (CMR) Rate at any time prior to radiation therapy: 92.9 Percent of participants.
- Overall Response Rate (ORR) following 4 cycles of nivolumab + brentuximab vedotin treatment: 96.4 Percent of participants.
- Event-free Survival (EFS) Rate at 3 years: 87.5 Percent of participants.
- Progression Free Survival (PFS) Rate at 3 years: 95.2 Percent of participants.
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
- Complete Metabolic Response (CMR) Rate at any time prior to high dose chemotherapy followed by autologous stem cell treatment (HDCT/ASCT): 88.6 Percent of participants.
- Overall Response Rate (ORR) following 4 cycles of nivolumab + brentuximab vedotin treatment: 93.2 Percent of participants.
- Progression Free Survival (PFS) Rate at 3 years: 91.1 Percent of participants.
Investigator-assessed results also showed:
- For Cohort 1, Complete Metabolic Response (CMR) Rate at any time prior to radiation therapy: 89.3 Percent of participants.
- For Cohort 1, Event-free Survival (EFS) Rate at 3 years: 88.5 Percent of participants.
- For Cohort 2, Complete Metabolic Response (CMR) Rate at any time prior to HDCT/ASCT: 86.4 Percent of participants.
What this means
The high complete metabolic response rates and overall response rates observed in both cohorts suggest that the combination of nivolumab and brentuximab vedotin is highly effective in achieving disease control in young patients with relapsed or refractory classic Hodgkin lymphoma. The favorable 3-year event-free survival and progression-free survival rates further indicate sustained benefit from this treatment approach. These results may support the use of this combination therapy in this challenging patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02927769, titled "A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment," were posted on 2025-02-10 on clinicaltrials.gov.