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CAR T-cell Therapy

Dendritic Cell Vaccine + Standard Therapy for Glioblastoma (DERIVe Trial)

Phase 2

Waitlist Available

Led By Annick Desjardins, MD, FRCPC

Research Sponsored by Annick Desjardins, MD

Eligibility Criteria Checklist

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

Must have

Glioblastoma with definitive resection prior to enrollment, with residual radiographic contrast enhancing disease on the post-operative CT or MRI of <1 cm in maximal diameter in any plane

MRI post RT does not show progressive disease outside the radiation field

Must not have

Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Patients who cannot undergo MRI due to obesity or to having certain metal in their bodies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a vaccine as treatment for newly diagnosed glioblastoma. Patients will have surgery to remove the tumor, then have their blood drawn. From the blood, dendritic cells will be made. The patient will then receive standard radiation and chemotherapy, and during this treatment will also receive up to 10 injections of the dendritic cell vaccine. The vaccine will be given every 2 weeks, with each treatment cycle being 4 weeks long.

Who is the study for?

Adults with glioblastoma who've had a tumor resection, meet certain health criteria (like KPS ≥ 70%, specific blood cell counts), are not pregnant or breastfeeding, agree to use effective contraception, and can undergo standard radiation/chemotherapy. Excluded are those with severe allergies, metal implants preventing MRI, other cancers needing active treatment, certain infections or heart conditions.

What is being tested?

The trial tests dendritic cell vaccines in glioblastoma patients post-surgery. Patients receive standard radiation and temozolomide chemotherapy plus up to 10 DC vaccines. They're randomized into groups receiving different pre-conditioning before the fourth vaccine; one group also gets varlilumab infusions.

What are the potential side effects?

Possible side effects include reactions at the injection site from the vaccines or infusions, typical chemotherapy side effects like nausea and fatigue from temozolomide, and potential immune-related issues due to varlilumab such as inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I had surgery for glioblastoma and my latest scans show a small remaining area of less than 1 cm.

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My MRI after radiation shows no cancer spread outside the treated area.

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My tumor tissue is sufficient for MGMT gene status testing.

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I can undergo standard radiation and chemotherapy for about 6 weeks.

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I am mostly able to care for myself.

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I am 18 years old or older.

Exclusion Criteria

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

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I am not using birth control and can become pregnant or cause pregnancy.

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I cannot have an MRI due to my weight or because I have certain metal implants.

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My cancer has spread to my brain.

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I do not have severe health issues like heart problems, serious infections, liver issues, or untreated cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Median Overall Survival (OS) of Subjects Receiving Td pre-conditioning

Median percent change between baseline, assessed on day 14, and nadir levels of Treg before the time that the second cycle of adjuvant TMZ would be administered. Treg determined by flow cytometry (CD3+ CD4+ CD25+ Foxp3+).

Safety of administering Varlilumab to GBM patients receiving temozolomide and dendritic cell vaccines ± Td pre-conditioning as measured by the percentage of patients with unacceptable toxicity regardless of attribution

Secondary study objectives

Median Chemokine (C-C motif) ligand 3 (CCL3) Levels in Serum at 24, 48, and 72 hours after Pre-conditioning

Median Overall Survival (OS) of Subjects Receiving DC vaccines, varlilumab, and Td pre-conditioning

Median Progression-free Survival (PFS)

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: Gr3:DC Vaccine+varlilumab(Td pre-conditioning)Experimental Treatment4 Interventions

Patients will receive TMZ at a target dose of 150-200 mg/m\^2/d for 5 days every 4 (+2) weeks for up to 12 cycles. DC vaccines will be administered in equal amounts to both inguinal regions. DC vaccines #1-3 occur every 2 weeks and all subsequent vaccines (up to 10) occur monthly. Group 3 patients will receive the first 3 DC vaccines every 2 weeks, same as Groups 1 and 2, but they will also receive varlilumab intraveneously (IV) 7 days before vaccine #1 and again at the same visit as vaccine #1, as well as 7 days before every DC vaccine except vaccine #2. Prior to the 4th vaccine, patients will receive a single dose of Td toxoid administered to a single side of the groin and saline administered to the contralateral side.

Group II: Gr2: DC Vaccine (Td pre-conditioning)Experimental Treatment3 Interventions

Patients will receive TMZ at a target dose of 150-200 mg/m\^2/d for 5 days every 4 (+2) weeks for up to 12 cycles. DC vaccines will be administered in equal amounts to both inguinal regions. DC vaccines #1-3 occur every 2 weeks and all subsequent vaccines (up to 10) occur monthly. Group 2 patients will receive a single dose of Td toxoid administered to a single side of the groin and saline administered to the contralateral side the day prior to the 4th DC vaccine, which is always given bilaterally at the groin site.

Group III: Gr1: DC vaccine (DC pre-conditioning)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Human CMV pp65-LAMP mRNA-pulsed autologous DCs

2015

Completed Phase 2

~70

Temozolomide

2010

Completed Phase 3