Trial results for a Phase 2 study (NCT04938232) investigating ipilimumab with or without nivolumab in relapsed/refractory classic Hodgkin's lymphoma (cHL) were posted on ClinicalTrials.gov on 2025-04-03. The study reported an overall response rate (ORR) of 15 percent for the ipilimumab and nivolumab combination therapy, compared to 23 percent for ipilimumab monotherapy, according to Lugano criteria.
Background
This study investigated the effects of ipilimumab alone or in combination with nivolumab in patients diagnosed with relapsed or refractory classic Hodgkin's lymphoma (cHL). Nivolumab and ipilimumab are both immunotherapeutic agents used in oncology.
Trial design
The study (NCT04938232) was a Phase 2 trial with an enrollment of 13 participants. It evaluated ipilimumab with or without nivolumab in patients with Hodgkin Lymphoma, specifically relapsed Hodgkin's disease, adult, and refractory Hodgkin lymphoma. The study compared ipilimumab monotherapy against ipilimumab and nivolumab combination therapy.
Key results
The trial results provided several key measurements for patients with disease progression after previous therapy:
- The Overall Response Rate (ORR) for ipilimumab monotherapy was 23 percent according to both Lugano and LYRIC criteria.
- The Complete Response Rate (CRR) for ipilimumab monotherapy was 0 percent according to both Lugano and LYRIC criteria.
- For ipilimumab and nivolumab combination therapy, the ORR was 15 percent by Lugano criteria and 8 percent by LYRIC criteria.
- Progression-free Survival was reported as 38 percent (95% Confidence Interval) by LYRIC criteria and 49 percent (95% Confidence Interval) by Lugano criteria.
- The Duration of Response was 100 percent (95% Confidence Interval).
- Overall Survival was reported as 75 percent (95% Confidence Interval).
- The percentage of patients with Grade 3+ Treatment-Related Adverse Events was 46 percent (90% Confidence Interval).
What this means
The results suggest that in this small Phase 2 study population of patients with relapsed or refractory cHL, ipilimumab monotherapy demonstrated a numerically higher overall response rate compared to the ipilimumab and nivolumab combination therapy when assessed by Lugano criteria (23 percent vs 15 percent). However, complete responses were not observed with monotherapy. The safety profile indicated a substantial proportion of patients experienced Grade 3+ treatment-related adverse events. These findings provide initial insights into the activity of these regimens in a challenging patient population, though the small sample size warrants cautious interpretation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04938232, titled "Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL," were posted on 2025-04-03 on clinicaltrials.gov.