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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
DERIVe Trial 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.Check my eligibility
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.See study design
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.
DERIVe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
DERIVe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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)
DERIVe 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
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 1 patients will receive autologous unpulsed DC vaccines administered to a single side of the groin and saline administered to the contralateral side the day prior to the 4th DC vaccine as pre-conditioning.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Unpulsed DCs
2015
Completed Phase 2
~70
Td
2016
Completed Phase 3
~850
Human CMV pp65-LAMP mRNA-pulsed autologous DCs
2015
Completed Phase 2
~70
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
Annick Desjardins, MDLead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
Celldex TherapeuticsIndustry Sponsor
60 Previous Clinical Trials
3,787 Total Patients Enrolled
4 Trials studying Glioblastoma
1,129 Patients Enrolled for Glioblastoma
Gary Archer Ph.D.Lead Sponsor
11 Previous Clinical Trials
249 Total Patients Enrolled
9 Trials studying Glioblastoma
195 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not using birth control and can become pregnant or cause pregnancy.I had surgery for glioblastoma and my latest scans show a small remaining area of less than 1 cm.My MRI after radiation shows no cancer spread outside the treated area.I cannot have an MRI due to my weight or because I have certain metal implants.My kidney and liver tests are within acceptable limits for my age.I am not pregnant or breastfeeding and, if capable of becoming pregnant, I use effective birth control.My tumor tissue is sufficient for MGMT gene status testing.My cancer has spread to my brain.I can undergo standard radiation and chemotherapy for about 6 weeks.I do not have severe health issues like heart problems, serious infections, liver issues, or untreated cancer.I am mostly able to care for myself.I am a man who can father children and will use effective birth control during and for 6 months after the trial.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Gr3:DC Vaccine+varlilumab(Td pre-conditioning)
- Group 2: Gr1: DC vaccine (DC pre-conditioning)
- Group 3: Gr2: DC Vaccine (Td pre-conditioning)
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 trial the inaugural example of its type?
"As of now, 213 active clinical trials for Human CMV pp65-LAMP mRNA-pulsed autologous DCs are taking place in 36 nations and 940 cities. The original study began almost two decades ago when Schering-Plough sponsored a Phase 2 evaluation with 60 patients; since then, 301 studies have been completed."
Answered by AI
What maladies are typically addressed with Human CMV pp65-LAMP mRNA-pulsed autologous DCs treatments?
"Patients with nitrosourea treatment often receive Human CMV pp65-LAMP mRNA-pulsed autologous DCs. This same approach is also employed to address other complex medical conditions such as advanced directives, refractory mycosis fungoides and neuroblastoma that have been unresponsive to more conventional treatments."
Answered by AI
Could you provide information regarding prior experiments with Human CMV pp65-LAMP mRNA-pulsed autologous DCs?
"At present, 213 clinical studies are investigating Human CMV pp65-LAMP mRNA-pulsed autologous DCs with 24 of those in Phase 3. Of the 4823 locations conducting trials for this protocol, most are situated in Seoul, Songpa."
Answered by AI
How many individuals are actively participating in this research endeavor?
"Affirmative. According to the information displayed on clinicaltrials.gov, this research study is actively searching for 80 participants at a single medical facility. The trial was first listed on August 26th 2020 and has recently been updated in May of 2022."
Answered by AI
Are any openings available to volunteers for this experiment?
"Current information posted on clinicaltrials.gov attests to the fact that this trial is presently recruiting participants, having started on August 26th 2020 and most recently edited on May 26th 2022."
Answered by AI
Has the FDA sanctioned Human CMV pp65-LAMP mRNA-pulsed autologous DCs for clinical use?
"The safety profile of Human CMV pp65-LAMP mRNA-pulsed autologous DCs was rated a 2, as there is evidence to support its protections but no data attesting to its efficacy."
Answered by AI
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