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Cancer Vaccine
Varlilumab + IMA950 + Poly-ICLC for Brain Tumor
Phase 1
Waitlist Available
Led By Hideho Okada, MD, PhD
Research Sponsored by Nicholas Butowski
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be positive for HLA-A2 based on flow-cytometry or genotyping
Patients must have a Karnofsky performance status (KPS) of >= 70%.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing a new vaccine combination to see if it is safe and effective in treating patients with brain tumors.
Who is the study for?
Adults over 18 with low-grade glioma (WHO grade II) such as astrocytoma, oligoastrocytoma, or oligodendroglioma. They must have a certain immune system marker (HLA-A2+), be able to undergo surgery, and have good organ function. Previous treatments are allowed if enough time has passed. Pregnant women and those with serious health issues or high-grade tumors are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and immune response of a new cancer vaccine combination in patients before tumor removal surgery. It involves IMA950 peptides plus poly-ICLC given under the skin and Varlilumab through IV to see if it boosts T-cell responses against tumor cells.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, flu-like symptoms from immune activation, allergic reactions, fatigue, and possible autoimmune responses due to increased activity of the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HLA-A2 positive.
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I am mostly able to care for myself and carry out daily activities.
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My blood, liver, and kidney functions are within normal ranges.
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I am 18 years old or older.
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My MRI shows I have brain lesions that can be surgically removed, and enough tissue can be taken for study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Magnitude of CD4+ T-cell responses responses in pre- and post-vaccine PBMC
Magnitude of CD8+ T-cell responses responses in pre- and post-vaccine PBMC
Proportion of participants with Regimen Limiting Toxicity (RLT)
+2 moreOther outcome measures
Association of PBMC responses with overall survival
Association of PBMC responses with reactive T-cells in the tumor
Frequency of CXCL9/10 expression
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: IMA950/poly-ICLC subcutaneous (subQ) + Varlilumab IVExperimental Treatment3 Interventions
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously followed immediately by a Varlilumab 3mg/kg infusion (intravenously) -23±2 days (about 3 weeks) before the date of scheduled standard-of-care surgery to remove the WHO grade II glioma. Patients will continue receiving IMA950/poly-ICLC subcutaneous injections every week leading up to surgery (Days -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every 3 weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). After surgery, patients will continue receiving a Varlilumab infusion every 6 weeks immediately following the IMA950/poly-ICLC injection (Weeks A1, A7, A13, and A19).
Group II: IMA950/poly-ICLC subQ onlyExperimental Treatment2 Interventions
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously every week leading up to standard-of-care surgery to remove the WHO grade II glioma (Days -23±2, -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every three weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). Patients will not receive Varlilumab.
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Who is running the clinical trial?
Nicholas ButowskiLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
Celldex TherapeuticsIndustry Sponsor
60 Previous Clinical Trials
3,816 Total Patients Enrolled
Hideho Okada, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Astrocytoma
28 Patients Enrolled for Astrocytoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HLA-A2 positive.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am mostly able to care for myself and carry out daily activities.I have been on a low dose (4 mg or less) of corticosteroids or none at all for the last two weeks.I am not pregnant or breastfeeding.I am not currently using treatments like radiation, chemotherapy, or specific medications.You have a medical or psychological condition that may increase the risk of participating in the trial or make it difficult to understand the trial results as determined by the investigator.My tumor is a grade II astrocytoma, oligoastrocytoma, or oligodendroglioma confirmed by biopsy or surgery.I've had a break from certain cancer treatments for the required time.My blood, liver, and kidney functions are within normal ranges.I agree to use effective birth control during the study.I have a condition like AIDS, MS, diabetes, or kidney failure that could affect my immune system.I have had skin cancer, breast, or cervical cancer in situ without spread.I agree to use birth control or abstain from sex during the study and for one month after.My tumor was upgraded to a higher grade after surgery.I am currently taking immunosuppressive drugs or more than 4mg of dexamethasone.My MRI shows signs of a serious brain tumor.I have or had an immune system condition treated with drugs affecting my immune response.I am 18 years old or older.I do not have any ongoing infections and haven't taken antibiotics in the last 7 days.I completed my radiation therapy at least 6 months ago.You have a known addiction to drugs.My MRI shows I have brain lesions that can be surgically removed, and enough tissue can be taken for study.My cancer has spread to the brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: IMA950/poly-ICLC subQ only
- Group 2: IMA950/poly-ICLC subcutaneous (subQ) + Varlilumab IV
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 research a pioneering endeavor?
"Since its inception in 2017, poly-ICLC has been subject to a variety of clinical trials. Initially sponsored by Celldex Therapeutics, the first investigation included 14 patients and eventually culminated in Phase 1 drug approval. Currently, there are 7 active studies for this medication that span 2 countries and 50 cities."
Answered by AI
What potential hazards are associated with poly-ICLC?
"Clinical data regarding the safety of poly-ICLC is limited, resulting in it receiving a score of 1."
Answered by AI
How many subjects have been enlisted to participate in this investigation?
"The trial is not currently recruiting participants, as it was last updated on July 14th 2022. However, if you are seeking alternative clinical trials, 391 studies involving glioma and 7 studies concerning poly-ICLC have active recruitment programs."
Answered by AI
Are there still openings available for this clinical evaluation?
"Unfortunately, this trial is no longer accepting volunteers. It was initially posted on April 3rd 2017 and has since been amended for the last time on July 14th 2022. If you are looking to join other trials related to glioma, there are currently 391 studies actively enrolling patients while 7 clinical trials offer poly-ICLC treatments that have open recruitment."
Answered by AI
Has there been any other research done related to poly-ICLC?
"Presently, there are 7 studies involving poly-ICLC that have yet to be completed. None of them have progressed past Phase 3 at this time. Interestingly, the majority of these trials take place in California's San Francisco area and across 72 different sites globally."
Answered by AI
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