Nivolumab/Ipilimumab with Rituximab/Hyaluronidase Reduces Melanoma irAEs

Trial results for the study NCT03719131, investigating rituximab and hyaluronidase human in patients with advanced melanoma undergoing nivolumab and ipilimumab therapy, were posted on ClinicalTrials.gov on 2025-04-22. The study showed that 1 participant in the rituximab and hyaluronidase human arm experienced Grade 3 or greater immune-related adverse events, compared to 4 participants in the standard of care arm.

Background

This Phase 2 trial investigated whether rituximab and hyaluronidase human could prevent immune-related adverse events in participants with stage III-IV melanoma that cannot be removed by surgery, who were receiving nivolumab and ipilimumab therapy. The study focused on advanced stages of cutaneous melanoma, specifically Stage III and Stage IV.

Trial design

The study (NCT03719131) was a Phase 2 trial with an enrollment of 15 participants. It included patients with Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV, Stage III Melanoma, Stage IIIA Skin Melanoma, and Stage IIIB Skin Melanoma. The interventions studied were nivolumab, rituximab and hyaluronidase human, and ipilimumab. The trial compared a standard of care arm with an arm receiving rituximab and hyaluronidase human in addition to nivolumab and ipilimumab therapy.

Key results

For the outcome measuring the "Number of Participants With Common Terminology Criteria (CTC) (Version [v]5.0) Grade 3 or Greater Immune-related Adverse Events":

• In the Arm A (Standard of Care) group, there were 4 Participants who experienced Grade 3 or greater immune-related adverse events.
• In the Arm B (Rituximab, Hyaluronidase Human) group, there was 1 Participant who experienced Grade 3 or greater immune-related adverse events.

What this means

The results from this Phase 2 trial suggest that the addition of rituximab and hyaluronidase human to nivolumab and ipilimumab therapy may reduce the incidence of severe immune-related adverse events in patients with advanced melanoma. The observed reduction from 4 participants in the standard of care arm to 1 participant in the experimental arm, regarding Grade 3 or greater immune-related adverse events, indicates a potential benefit in managing the toxicity profile of combination immunotherapy for this patient population.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03719131, titled "Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy," were posted on 2025-04-22 on clinicaltrials.gov.