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Monoclonal Antibodies

Anti-GITR/PD1 + SRS for Recurrent Glioblastoma

Hospital of the University of Pennsylvania, Philadelphia, PA
Brain surgery +3 morePhase 2Waitlist AvailableLed by Stephen Bagley, MD, MSCEResearch Sponsored by University of Pennsylvania

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 below
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You stopped taking chemotherapy treatment that is not nitrosourea at least 3 weeks ago.
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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.
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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.
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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.
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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.
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You have received nitrosourea chemotherapy within the last 6 weeks.
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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 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

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

INCAGN01876 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04225039 — Phase 2
Glioblastoma Research Study Groups: Cohort A, Cohort B sub-arm #1, Cohort B sub-arm #2
Glioblastoma Clinical Trial 2023: INCAGN01876 Highlights & Side Effects. Trial Name: NCT04225039 — Phase 2
INCAGN01876 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04225039 — Phase 2

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
~9 spots leftby Nov 2024