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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
3 weeks from a non-nitrosourea cytotoxic chemotherapy
Participants must have glial tumor that is recurrent following prior first-line radiation therapy (prior dose must have been 40-75 Gy and may have been either photon or proton radiation), and must have unequivocal evidence of tumor progression by MRI scan
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up84 months
Awards & highlights
No Placebo-Only Group
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.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You stopped taking chemotherapy treatment that is not nitrosourea at least 3 weeks ago.
Select...
You have a type of brain tumor called glial tumor that has come back after previous treatment with radiation therapy. Your MRI scan shows clear signs of the tumor getting worse. The previous radiation dose you received was between 40-75 Gy with either photon or proton radiation.
Select...
You have a tumor that can be treated with stereotactic radiosurgery (SRS) and it needs to be at least 1cm x 1cm in size but no larger than 4cm in diameter. Your doctor will decide if you are a candidate for SRS and make sure the treatment won't cause harm. You can have more than one tumor as long as they meet these requirements.
Select...
You have been diagnosed with a specific type of brain cancer called glioblastoma or gliosarcoma. You may also be eligible if you were previously diagnosed with low-grade glioma and now have a diagnosis of glioblastoma.
Select...
If you have had a brain tumor before, we need to know if your tumor has specific changes in a gene called MGMT. We will use standard tests to determine this.
Select...
You have received nitrosourea chemotherapy within the last 6 weeks.
Select...
For Sub-Arms 2 of Cohort B, the size of your tumor does not matter, and it does not need to be treatable with SRS.
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
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
SRS
2014
N/A
~9190
INCAGN01876
2016
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,962 Previous Clinical Trials
42,526,498 Total Patients Enrolled
7 Trials studying Glioblastoma
166 Patients Enrolled for Glioblastoma
Incyte CorporationIndustry Sponsor
347 Previous Clinical Trials
50,789 Total Patients Enrolled
5 Trials studying Glioblastoma
584 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:- You stopped taking chemotherapy treatment that is not nitrosourea at least 3 weeks ago.You are expected to live for at least 3 more months.You have a significant brain swelling that could cause pressure in the middle of your brain.You have had a previous bone marrow or organ transplant.You have a heart condition that is not well-managed or is severe.You received a live vaccine within a month before taking the study drug.You can have received treatment for cancer before, but you can't have received a specific type of medication called bevacizumab or other vascular endothelial growth factor inhibitors unless it was given to treat radiation necrosis and stopped at least 4 weeks before a MRI scan showed your tumor was growing. If you received gliadel wafers, they can only have been given during your first surgery for GBM at the time of initial diagnosis.You have finished radiation therapy at least 12 weeks ago.You have received nitrosourea chemotherapy within the last 6 weeks.You have shown an allergic reaction to another type of antibody.You have had or currently have another type of cancer that may affect your safety or the evaluation of the study's effectiveness.You are currently pregnant.You can swallow pills or tablets.You have a type of brain tumor called glial tumor that has come back after previous treatment with radiation therapy. Your MRI scan shows clear signs of the tumor getting worse. The previous radiation dose you received was between 40-75 Gy with either photon or proton radiation.You cannot participate if you are already enrolled in another clinical trial that involves treatment.You have a history of lung inflammation that required treatment with steroids.You have a severe medical condition, ongoing infection, or serious illness that is not under control.You have been previously diagnosed with a weakened immune system.You have received medication for autoimmune or connective tissue disease recently or still undergoing treatment.You have a tumor that can be treated with stereotactic radiosurgery (SRS) and it needs to be at least 1cm x 1cm in size but no larger than 4cm in diameter. Your doctor will decide if you are a candidate for SRS and make sure the treatment won't cause harm. You can have more than one tumor as long as they meet these requirements.Only patients who need surgery as determined by their healthcare provider are eligible for Cohort B.You have been diagnosed with a specific type of brain cancer called glioblastoma or gliosarcoma. You may also be eligible if you were previously diagnosed with low-grade glioma and now have a diagnosis of glioblastoma.If you have had a brain tumor before, we need to know if your tumor has specific changes in a gene called MGMT. We will use standard tests to determine this.For Sub-Arms 2 of Cohort B, the size of your tumor does not matter, and it does not need to be treatable with SRS.If you are part of Sub-Arms 2 in Cohort B, the size of your tumor does not matter and it does not need to be treatable with SRS (Stereotactic Radiosurgery).
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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