Surgical Nivolumab And Ipilimumab For Recurrent GBM
NCT04606316 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63
Last updated 2026-02-17
Summary
This research trial is studying the safety and effectiveness of nivolumab in combination with ipilimumab and surgery when used in the treatment of recurrent glioblastoma.
The names of the study drugs involved in this study are:
* Nivolumab
* Ipilimumab
* Placebo (IV solution with no medicine)
* Zr-89 Crefmirlimab berdoxam (optional sub-study)
Conditions
- Glioblastoma
- GBM
- Glioblastoma Multiforme
- Grade IV Astrocytoma
Interventions
- DRUG
-
Nivolumab-Placebo
Intravenous (IV) solution that has no therapeutic effect, used as a control in testing investigational drug. One dose is received prior to surgery.
- DRUG
-
Given as intravenous (IV) infusion into a vein.
- DRUG
-
Ipilimumab-Placebo
Intravenous (IV) solution that has no therapeutic effect, used as a control in testing investigational drug. One dose is received prior to surgery.
- DRUG
-
Given as intravenous (IV) infusion into a vein.
- PROCEDURE
-
Surgery
Treatment of disease or injury by cutting, abrading, suturing, or otherwise physically changing body tissues and organs.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Patrick Wen, MD
lead OTHER
Principal Investigators
-
Patrick Y Wen, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-01
- Primary Completion
- 2026-12-30
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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