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PD-1 Inhibitor

MK-3475 + MRI-guided Laser Ablation for Brain Tumor

Phase 1 & 2
Waitlist Available
Led By Milan G Chheda, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For grade IV malignant gliomas (GBM): Standard front line therapy for newly diagnosed GBM must include maximal feasible surgical resection (biopsy alone allowed), radiotherapy, and temozolomide chemotherapy. If the tumor was initially diagnosed as either a grade II or III tumor and now has recurred or progressed as a grade IV GBM, it will be considered a secondary recurrent grade IV GBM and will be eligible for this study as long as prior treatment included maximal feasible surgical resection (biopsy alone allowed), radiotherapy, and temozolomide chemotherapy.
Phase II: Histologically confirmed grade IV malignant glioma (GBM).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after completion of treatment (estimated to be up to 272 weeks)
Awards & highlights

Study Summary

This trial is testing whether a combination of two treatments can better control brain tumors than either treatment alone. MLA is a type of surgery that uses lasers to target and destroy tumors. MK-3475 is a drug that helps the immune system better recognize and attack tumors.

Who is the study for?
Adults with grade III or IV malignant glioma (GBM) showing tumor progression, who've had standard treatments including surgery, radiotherapy, and chemotherapy. They must be candidates for MRI-guided laser ablation (MLA), have a Karnofsky performance status of ≥60%, normal organ function, agree to use contraception during the study and for 120 days after the last dose of MK-3475.Check my eligibility
What is being tested?
The trial is testing if combining MK-3475 with MLA can better control brain tumors by disrupting the blood-brain barrier to enhance immune system response against the tumor. Participants will undergo MLA and receive MK-3475 injections while being monitored through biopsies and blood draws.See study design
What are the potential side effects?
Possible side effects include reactions related to immune activation such as inflammation in various organs, potential lung issues like pneumonitis, infusion-related reactions from MK-3475 injections, fatigue, increased risk of infections due to immunosuppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor was treated with surgery, radiation, and chemotherapy.
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I have been diagnosed with a grade IV brain tumor (GBM).
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I am a candidate for a specific brain tumor treatment as decided by my neurosurgeon.
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I have been diagnosed with a grade IV brain tumor (GBM).
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I had surgery to remove a cancer recurrence.
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My grade III brain tumor was treated with surgery, radiation, and chemo, but it came back.
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My grade III brain tumor was treated with surgery, radiation, and chemotherapy.
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I had surgery to remove a recurring tumor and may receive treatment to target the area around the surgery site.
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My brain tumor is confirmed to be high-grade (grade III or IV).
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My cancer has shown clear growth on recent scans or biopsies.
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My blood tests for bone marrow and organ function are normal.
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My cancer has clearly worsened, as shown by recent tests.
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I am 18 years old or older.
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My diagnosis includes GBM or its variants.
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My brain tumor is confirmed to be high-grade (grade III or IV).
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I am mostly able to care for myself but may need occasional help.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 90 days after completion of treatment (up to 168 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 90 days after completion of treatment (up to 168 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximal tolerated dose (MTD) of MK-3475 when combined with MLA - Phase I only
Progression-free survival (PFS) of patients being treated with MK-3475 plus MLA - Phase II only
Secondary outcome measures
Anti-glioma immune response before and after MK-3475 with MLA - Phase II only
Correlate intratumoral expression of PD-L1 and the frequency of glioma cell-specific cytotoxic T cells with OS - Phase II only
Correlate intratumoral expression of PD-L1 and the frequency of glioma cell-specific cytotoxic T cells with PFS - Phase II only
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase II: MK-3475 Only (Arm B)Experimental Treatment5 Interventions
In the phase II portion of this study, MK-3475 will be given every 3 weeks beginning 3 weeks after surgical debulking or no more than 1 week after biopsy (if no debulking) The phase II dose was determined during the Phase I portion of the study. Patients enrolling in phase II will need to have tissue available for diagnostic purpose and for immunological monitoring. Surgical resection/debulking is per standard of care and optional for the purpose of this study and the performing neurosurgeon will determine whether each patient will undergo surgery. For those not undergoing surgical resection/debulking, a biopsy for tissue diagnosis and immune monitoring will only be performed when clinically warranted.
Group II: Phase II: MK-3475 + MLA (Arm A)Experimental Treatment6 Interventions
In the phase II portion of this study, MK-3475 will be given every 3 weeks no more than 1 week after MLA, or no more than 1 week after biopsy (if no debulking). The phase II dose will be determined during the phase I portion of this study and is 200 mg. Patients enrolling in phase II will need to have tissue available for diagnostic purpose and for immunological monitoring. Surgical resection/debulking is per standard of care and optional for the purpose of this study and the performing neurosurgeon will determine whether each patient will undergo surgery. --For those not undergoing surgical resection/debulking, a biopsy for tissue diagnosis and immune monitoring will be performed during MLA MLA will take place at least 3 weeks but not more than 6 weeks after surgical resection/debulking or if no surgical resection/debulking will start on day 1
Group III: Phase II (after amendment #12): MK-3475 + MLAExperimental Treatment6 Interventions
After amendment 12, all patients will be enrolled in this arm MK-3475 will be given every 3 weeks no more than 1 week after MLA The phase II dose will be determined during the phase I portion of this study and is 200 mg. Patients enrolling in phase II will need to have tissue available for diagnostic purpose and for immunological monitoring. Surgical resection/debulking is per standard of care and optional for the purpose of this study and the performing neurosurgeon will determine whether each patient will undergo surgery. For those not undergoing surgical resection/debulking, a biopsy for tissue diagnosis and immune monitoring will be performed during MLA MLA will take place at least 3 weeks but not more than 6 weeks after surgical resection/debulking or if no surgical resection/debulking will start on day 1
Group IV: Phase I: MK-3475 + MLAExperimental Treatment3 Interventions
-In the phase I portion of this study, MK-3475 will be given every 3 weeks starting no more than 1 week after MLA until progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-3475
2014
Completed Phase 2
~1290
Biopsy
2014
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,033 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,645 Total Patients Enrolled
Milan G Chheda, M.D.Principal InvestigatorWashington University School of Medicine

Media Library

MK-3475 (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02311582 — Phase 1 & 2
Malignant Glioma Research Study Groups: Phase I: MK-3475 + MLA, Phase II: MK-3475 Only (Arm B), Phase II: MK-3475 + MLA (Arm A), Phase II (after amendment #12): MK-3475 + MLA
Malignant Glioma Clinical Trial 2023: MK-3475 Highlights & Side Effects. Trial Name: NCT02311582 — Phase 1 & 2
MK-3475 (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02311582 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this type of surgery have a precedent?

"City of Hope conducted the first clinical trial for MRI-guided laser ablation in 2010 and, since then, there have been 286 completed trials. As of now, there are 1000 active trials taking place with several hospitals in Saint Louis, Missouri."

Answered by AI

What types of conditions does MRI-guided laser ablation target?

"While most commonly used to treat malignant neoplasms, MRI-guided laser ablation can also be an effective treatment for certain conditions like microsatellite instability high and disease progression after chemotherapy."

Answered by AI
~0 spots leftby Mar 2024