Trial results for the Phase 2 study NCT02648997 investigating nivolumab as monotherapy or in combination with ipilimumab for adult participants with progressive/recurrent meningioma were posted on ClinicalTrials.gov on 2026-01-26. The study reported that 10 participants in the nivolumab monotherapy arm and 10 participants in one of the combination arms were without disease progression at six months following initiation of study therapy.
Background
The study, titled "An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma," aimed to evaluate targeted immunotherapies as a potential treatment for recurrent meningioma. The interventions involved in this study were nivolumab and ipilimumab.
Trial design
The study NCT02648997 was an open-label Phase 2 trial that enrolled 40 adult participants with progressive or recurrent meningiomas. The study investigated nivolumab as monotherapy and nivolumab in combination with ipilimumab. Interventions included nivolumab 240 mg, ipilimumab 1 mg/kg, nivolumab 480 mg, nivolumab 3 mg/kg, and nivolumab 1 mg/kg.
Key results
The primary outcome measured was the "Number of Participants Without Disease Progression At Six Months Following Initiation Of Study Therapy." The results for this outcome were:
- In Cohort 1 (Original Cohort): Nivolumab Monotherapy, 10 Participants were without disease progression at six months.
- In Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab, 3 Participants were without disease progression at six months.
- In Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab, 10 Participants were without disease progression at six months.
What this means
The results from this Phase 2 trial suggest that both nivolumab monotherapy and its combination with ipilimumab may demonstrate disease control in some adult participants with progressive or recurrent meningioma. The observation of participants without disease progression at six months in both monotherapy and combination arms provides preliminary data on the activity of these immunotherapies 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 NCT02648997, titled "An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma," were posted on 2026-01-26 on clinicaltrials.gov.