← Back to Search

Monoclonal Antibodies

Immunotherapy + Radiosurgery for Glioblastoma

Phase 2

Waitlist Available

Led By Stephen Bagley, MD, MSCE

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status >= 60

Cohort B (surgical) patients: Must be undergoing clinically indicated surgery

Must not have

Active or recent systemic treatment for autoimmune or connective tissue disease

Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of two immunotherapy drugs and stereotactic radiosurgery to see if it is safe and effective in treating patients with recurrent glioblastoma.

Who is the study for?

Adults over 18 with recurrent glioblastoma who've completed prior treatments, have a life expectancy of more than 3 months, and adequate organ function. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with certain brain locations of cancer, previous specific cancer treatments like VEGF inhibitors (unless for radiation necrosis), immunosuppressant use within six months, significant heart disease, other active cancers that could affect the trial's outcomes, or infectious conditions like hepatitis B/C or HIV.

What is being tested?

The study tests a combination therapy using INCAGN01876 (GITR agonist antibody), INCMGA00012 (anti-PD1 antibody), and stereotactic radiosurgery (SRS) in patients with recurrent glioblastoma. The goal is to evaluate safety and effectiveness in stimulating an immune response against the tumor.

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as inflammation in various organs due to antibodies INCAGN01876 and INCMGA00012. SRS can cause localized brain tissue damage leading to headaches, nausea, fatigue, hair loss at treatment site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can care for myself but may need occasional help.

Select...

I am scheduled for a surgery that my doctor says I need.

Select...

My brain tumor has returned after initial radiation treatment and is growing, confirmed by MRI.

Select...

My brain tumor's MGMT methylation status is known from a previous test.

Select...

My brain tumor has returned after initial radiation treatment and it's shown on an MRI.

Select...

I am 18 years old or older.

Select...

My brain tumor's MGMT methylation status is known from a previous test.

Select...

I have been diagnosed with a specific type of aggressive brain tumor.

Select...

I have been diagnosed with a high-grade brain tumor.

Select...

I've been taking a low dose of steroids or less for at least 5 days.

Select...

I can swallow pills.

Select...

It has been 12 weeks since I finished my radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently receiving or have recently received treatment for an autoimmune disease.

Select...

I do not have any serious, uncontrolled health conditions or infections.

Select...

I have had a solid organ or bone marrow transplant.

Select...

My brain scan shows significant pressure or shift.

Select...

My tumor in the brainstem or spinal cord is visible on contrast-enhanced scans.

Select...

I am HIV-positive and currently on antiretroviral therapy.

Select...

I am not detained for psychiatric or physical illness treatment.

Select...

I do not have another cancer that could affect this treatment's safety or results.

Select...

My cancer has spread to the lining of my brain and spinal cord.

Select...

I have not received a live vaccine in the last 30 days.

Select...

I have serious heart problems that are not under control.

Select...

I have had lung inflammation treated with steroids.

Select...

I have been diagnosed with an immune system deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Radiographic Response (ORR)

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events as Assessed by NCI CTCAE v 5.0

Overall Survival

Progression Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort B sub-arm #2Experimental Treatment3 Interventions

Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 + INCAGN01876 (without SRS). Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (IV every 4 weeks) and INCAGN01876 (IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first.

Group II: Cohort B sub-arm #1Experimental Treatment4 Interventions

Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 (500mg) + INCAGN01876 (300mg) + SRS. Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (500 mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first.

Group III: Cohort AExperimental Treatment3 Interventions

Subjects in this arm (N=16) receive a single priming dose of both INCMGA00012 (500mg) and INCAGN01876 (300mg) prior to stereotactic radiosurgery (SRS), then undergo SRS (8 Gy x 3 fractions). Following SRS, INCMGA00012 (500mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) are resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCMGA00012

2021

Completed Phase 1

~60

SRS

2017

N/A

~9300