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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can care for myself but may need occasional help.
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I am scheduled for a surgery that my doctor says I need.
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My brain tumor has returned after initial radiation treatment and is growing, confirmed by MRI.
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My brain tumor's MGMT methylation status is known from a previous test.
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My brain tumor has returned after initial radiation treatment and it's shown on an MRI.
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I am 18 years old or older.
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My brain tumor's MGMT methylation status is known from a previous test.
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I have been diagnosed with a specific type of aggressive brain tumor.
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I have been diagnosed with a high-grade brain tumor.
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I've been taking a low dose of steroids or less for at least 5 days.
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I can swallow pills.
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It has been 12 weeks since I finished my radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 84 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Radiographic Response (ORR)
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events as Assessed by NCI CTCAE v 5.0
Overall Survival
Progression Free Survival
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
~9240
INCAGN01876
2016
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,841 Total Patients Enrolled
7 Trials studying Glioblastoma
166 Patients Enrolled for Glioblastoma
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,126 Total Patients Enrolled
5 Trials studying Glioblastoma
503 Patients Enrolled for Glioblastoma
Stephen Bagley, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Glioblastoma
18 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may need occasional help.I am currently receiving or have recently received treatment for an autoimmune disease.I've had treatments for relapses but never VEGF inhibitors, except for radiation necrosis.I do not have any serious, uncontrolled health conditions or infections.I am scheduled for a surgery that my doctor says I need.My brain tumor has returned after initial radiation treatment and is growing, confirmed by MRI.I have a tumor suitable for focused radiation, not larger than 4cm.I have had a solid organ or bone marrow transplant.My brain tumor's MGMT methylation status is known from a previous test.My brain tumor has returned after initial radiation treatment and it's shown on an MRI.You cannot participate if you are already enrolled in another clinical trial that involves treatment.My tumor can be any size and doesn't need to be removed with focused radiation.I am 18 years old or older.I am in Cohort B and my surgery is medically necessary as determined by my healthcare team.I have a tumor that is between 1cm and 4cm in size suitable for SRS.I have not taken drugs targeting blood vessel growth, except for treating radiation damage.I have not taken bevacizumab or similar drugs, except for treating radiation damage.My brain tumor's MGMT methylation status is known from a previous test.My brain scan shows significant pressure or shift.I haven't taken immunosuppressive drugs, except steroids, in the last 6 months.My tumor can be any size and doesn't need to be small enough for focused radiation.My liver and kidney functions are normal.My tumor in the brainstem or spinal cord is visible on contrast-enhanced scans.I have been diagnosed with a specific type of aggressive brain tumor.I have been diagnosed with a high-grade brain tumor.I am HIV-positive and currently on antiretroviral therapy.I've been taking a low dose of steroids or less for at least 5 days.I have recovered from serious side effects of my previous treatments.I am not detained for psychiatric or physical illness treatment.It's been over 3 weeks since my last non-nitrosourea chemotherapy.I do not have another cancer that could affect this treatment's safety or results.I can swallow pills.My cancer has spread to the lining of my brain and spinal cord.I have not received a live vaccine in the last 30 days.I have serious heart problems that are not under control.You are expected to live for at least 3 more months.It has been 12 weeks since I finished my radiation therapy.You have shown an allergic reaction to another type of antibody.You are currently pregnant.It has been 6 weeks since my last nitrosourea chemotherapy.I have had lung inflammation treated with steroids.I have been diagnosed with an immune system deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B sub-arm #1
- Group 3: Cohort B sub-arm #2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a never-before-attempted clinical trial?
"Since 2016, there has been a steady progression of research surrounding Brain surgery. Incyte Corporation first sponsored the clinical trial in which 325 patients took part; and following its successful completion, Phase 1 drug approval was granted. Currently 26 trials are ongoing across 117 cities and 43 nations."
Answered by AI
Are there any regulatory approvals for neurosurgical procedures?
"A score of 2 was assigned to brain surgery given that there is preliminary evidence for safety, but insufficient data on efficacy."
Answered by AI
How many individuals have signed up to take part in the experiment?
"At the present time, this study is not accepting participants. The trial was posted on June 23rd 2020 and last updated on April 11th 2022. Other clinical trials that are currently in need of patients with glioblastoma include 441 different studies while 26 research sites require people undergoing brain surgery to join their respective projects."
Answered by AI
Are there any notable investigations into the efficacy of Brain surgery?
"Currently, 26 studies researching Brain surgery are active with 3 trials in the final Phase. While most of these clinical investigations take place in A CORU�A and Virginia, 810 medical centres worldwide are conducting them."
Answered by AI
Does this experiment have any additional slots for people to participate?
"At present, this research project is no longer accepting new participants. Initially posted on June 23rd 2020 and last edited April 11th 2022, there are currently 441 ongoing studies recruiting patients with glioblastoma and 26 trials searching for volunteers to undergo brain surgery."
Answered by AI
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