An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma

Conditions

• Meningiomas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab - 240 mg — DRUG
  240 mg every 2 weeks
• Ipilimumab - 1 mg/kg — DRUG
  1 mg/kg every 3 weeks
• Nivolumab - 480 mg — DRUG
  480 mg once every 4 weeks
• Nivolumab - 3 mg/kg — DRUG
  3 mg/kg every 3 weeks
• External Beam RT — RADIATION
  IMRT, 3D-CRT, or proton-beam radiation therapy
• Nivolumab - 1 mg/kg — DRUG
  1 mg/kg every 3 weeks
• Ipilimumab - 3 mg/kg — DRUG
  3 mg/kg every 3 weeks

Study Details

This research study is studying targeted immunotherapies as a possible treatment for recurrent meningioma. The names of the study interventions involved in this study are nivolumab and ipilimumab.

Key Dates

Start date

Mar 31, 2016

Status verified

Jan 2026

Primary completion

Dec 1, 2024

Completion

Jun 1, 2026

Study Design

Enrollment

40 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 (original cohort): Nivolumab Monotherapy
  Nivolumab monotherapy (240 mg every 2 weeks)
• Experimental: Cohort 2 (Dose Level 0): Nivolumab in Combination with Ipilimumab
  * External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) * Followed by 4 cycles of Nivolumab (1 mg/kg every 3 weeks) + Ipilimumab (3 mg/kg every 3 weeks) * Followed by Nivolumab monotherapy (480 mg every 4 weeks).
• Experimental: Cohort 2 (Dose Level 0A): Nivolumab in Combination with Ipilimumab
  * External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) * Followed by 4 cycles of Nivolumab (3 mg/kg every 3 weeks) + Ipilimumab (1 mg/kg every 3 weeks) * Followed by Nivolumab monotherapy (480 mg every 4 weeks).

Primary Outcome Measure

Number of Participants Without Disease Progression At Six Months Following Initiation Of Study Therapy [ Time Frame: 6 months ]

Locations (1)

Related coverage on Hipa.ai

• Nivolumab Monotherapy and Combination Show Disease Control in Meningioma
  Nivolumab · Jan 26, 2026 · ClinicalTrials.gov

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