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Cancer Vaccine
Therapeutic Vaccine for Glioblastoma (ROSALIE Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Enterome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who are human leukocyte antigen (HLA)-A2 positive
Temozolomide stopped and wash-out period of 28 days before first study treatment (6 weeks for nitrosoureas and 5 half lives for experimental therapies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
ROSALIE Trial Summary
This trial is testing a new drug for brain cancer. It is assessing how safe and tolerable the drug is, as well as its ability to fight the cancer.
Who is the study for?
This trial is for adults over 18 with progressive or first recurrent glioblastoma, who have completed standard therapy including surgery and chemotherapy. They must be HLA-A2 positive, have a good performance status (ECOG ≤ 2 or Karnofsky ≥ 70), and not be on high doses of steroids. Pregnant women and those with certain medical conditions or recent other treatments are excluded.Check my eligibility
What is being tested?
The trial tests EO2401, a multipeptide therapeutic vaccine for safety, tolerability, immune response stimulation, and initial effectiveness in treating glioblastoma that has progressed after standard treatment.See study design
What are the potential side effects?
While specific side effects of EO2401 aren't listed here, vaccines like this could potentially cause reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, headache or muscle pain.
ROSALIE Trial 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 stopped taking Temozolomide 28 days ago, or other cancer drugs as specified before starting the study.
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I am HLA-A2 positive.
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My brain tumor has grown or returned, confirmed by an MRI.
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I am 18 years old or older.
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My glioblastoma has been confirmed to have progressed for the first time.
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I am mostly able to care for myself and remain up and about more than 50% of my waking hours.
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I have undergone surgery, radiation, and temozolomide treatment.
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I am mostly able to care for myself and carry out daily activities.
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I am 18 years old or older.
ROSALIE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of EO2401: National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0
Secondary outcome measures
Assessment of the immunogenicity of EO2316, EO2317, EO2318 (Three components of the therapeutic vaccine), and Universal Cancer Peptide that compose EO2401
Evaluation of survival
ROSALIE Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Multiple dose of EO2041 in combination with nivolumab and bevacizumab
Group II: Cohort 2Experimental Treatment1 Intervention
Multiple dose of EO2041 in combination with nivolumab
Group III: Cohort 1Experimental Treatment1 Intervention
Multiple dose of EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
Find a Location
Who is running the clinical trial?
EnteromeLead Sponsor
8 Previous Clinical Trials
453 Total Patients Enrolled
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,716 Total Patients Enrolled
Jean-Michel PaillarseStudy DirectorEnterome
1 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Cohort 2b is for people who do not have any visible signs of disease that can be measured through imaging.I am HLA-A2 positive.You are pregnant or breastfeeding.I stopped taking Temozolomide 28 days ago, or other cancer drugs as specified before starting the study.I am currently taking medication or herbal remedies that affect my immune system.I haven't had radiotherapy or specific cancer treatments in the last 28 days.I have had an organ or stem cell transplant.You have a history of drug or alcohol abuse.I have been cancer-free from any other cancer for less than 3 years.My glioblastoma has come back and I am a candidate for surgery.I have recent bleeding or seizures that are not under control.My tumor is located in the lower part of my brain.I have or might have an autoimmune disorder, including those affecting the nervous system.I have not received a live vaccine within the last 4 weeks.You have had an allergic reaction to any of the ingredients in the study medication.I am HLA-A2 positive.I have had tuberculosis in the past or currently have it.My brain tumor has grown or returned, confirmed by an MRI.I have undergone the standard initial treatment for my condition, including surgery, radiation, and temozolomide if it was needed.My cancer has an unmethylated MGMT promoter and I haven't taken temozolomide.I am 18 years old or older.I completed radiation therapy at least 28 days before starting this study.I haven't taken more than 2 mg/day of dexamethasone in the last 14 days, unless it was to treat a side effect.I stopped my temozolomide treatment 28 days ago, or longer for other specific drugs.I have or had HIV, hepatitis B, or hepatitis C.My glioblastoma has been confirmed to have progressed for the first time.I am mostly able to care for myself and remain up and about more than 50% of my waking hours.I have undergone surgery, radiation, and temozolomide treatment.My cancer has spread outside of my brain.I do not have any serious infections, heart problems, or significant health or mental conditions.I am mostly able to care for myself and carry out daily activities.My cancer has spread to the lining of my brain and spinal cord.I am 18 years old or older.You must have at least one visible and measurable lesion for the study.My glioblastoma has recurred and I am a candidate for surgery.I finished radiation therapy at least 28 days ago.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently being accepted into this experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this trial is actively recruiting and has been since July 13th 2020 . Approximately 52 participants need to be enrolled from one site in order for it to succeed."
Answered by AI
Is this trial still accepting participants?
"Indeed, the data available on clinicaltrials.gov corroborates that this medical trial is recruiting participants. This experiment was published on July 13th 2020 and has been recently updated on December 7th 2021. The study requires 52 volunteers from a single center to be enrolled in order to proceed."
Answered by AI
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