NCT04606316

Surgical Nivolumab And Ipilimumab For Recurrent GBM

A Phase Ib Clinical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters Following Neoadjuvant Anti-PD-1 (Nivolumab), or the Combination of Anti-PD-1 Plus Anti-CTLA-4 (Nivolumab Plus Ipilimumab) in Patients With Surgically Accessible Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Patrick Wen, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. It is expected that about 60 people will take part in this research study. There are 3 study groups participating in this study and each group receives different study drugs. After screening, participants will be randomized into one of three study groups. Participants will receive one of the following study treatments prior to undergoing surgery for tumor removal: * Group A receives nivolumab plus ipilimumab * Group B receives nivolumab plus placebo-ipilimumab * Group C receives two placebo infusions, placebo-nivolumab plus placebo-ipilimumab Neither the participant nor the research doctor will know which study drugs the participant will receive prior to surgery. After recovering from surgery, participants will receive the following doses of study medication: \-- Nivolumab plus ipilimumab every 3 weeks for 3 doses followed by nivolumab every 4 weeks This research study is a Phase Ib clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved the use of nivolumab or ipilimumab for your specific disease, but it has been approved for other uses. Both nivolumab and ipilimumab are antibodies (types of human protein) that work to stop tumor cells from growing and multiplying by immunotherapy. Immunotherapy is trying to have the body's own immune system work against tumor cells. Nivolumab and ipilimumab have been used in other research studies, and information from those other research studies suggest these drugs may help to stop glioblastoma cells from growing. Subjects also have the option of undergoing Zr-89 Crefmirlimab berdoxam PET scans. This consists of one infusion with Zr-89 Crefmirlimab berdoxam followed by a PET scan prior to starting study treatment and another infusion with PET scan about 3 days prior to surgery. The U.S. Food and Drug Administration (FDA) has not approved Zr-89 Crefmirlimab berdoxam as a treatment for any disease.

Conditions

• Glioblastoma
• GBM
• Glioblastoma Multiforme
• Grade IV Astrocytoma

Interventions

Type	Name	Description
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	Nivolumab	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	Ipilimumab	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-12-30
• Completion: 2026-12-31
• First posted: 2020-10-28
• Last updated: 2026-02-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study