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Glioblastoma, AdultPhase 1/2ROSALIENCT04116658

First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma

A Phase 1/2 study testing Multiple dose of EO2401 in people with Glioblastoma, Adult, run by Enterome at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in patients with unequivocal evidence of progressive or first recurrent glioblastoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Adult
What is being tested?
Multiple dose of EO2401
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
10 sitesin 4 countries
Study dates
13 Jul 2020to 4 Mar 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with unequivocal documented (including histological confirmation of Glioblastoma-GB- at the primary diagnosis) evidence of first progression/recurrence of GB on MRI, as defined by RANO criteria
  • Patients with :
  • for Cohorts 1, 2a, and 3: at least 1 measurable lesion
  • for Cohort 2b: no measurable enhancing disease
  • for Cohort 2c: documented recurrence of GB deemed to be candidate for surgery
  • Patients with an age ≥ 18 years old
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  • Patients who are human leukocyte antigen (HLA)-A2 positive
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky performance status ≥ 70
  • Patients should have received standard primary therapy, including surgery (biopsy, incomplete or complete resection), radiation, temozolomide, if applicable
  • Radiation therapy must have been finished 28 days before first study treatment administration
  • Patients who received temozolomide as adjuvant therapy must have stopped the treatment and have a wash-out period of 28 days before first study treatment administration (6 weeks for nitrosoureas and 5 half lives for experimental therapies)
  • Patients with unmethylated methylguanine-DNA-methyltransferase (MGMT) promoter can be included even if they have not received temozolomide prior to the inclusion in this clinical study)
  • Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to dosing
  • Considering the embryofetal toxicity of the nivolumab shown on animals' models, the following recommendations for contraception must be followed:
  • If not surgically sterile, female patients of childbearing potential age must use highly effective contraception from signing the Informed Consent Form (ICF) through 6 months after the last treatment dose administered. Highly effective contraception included: i. Combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: Oral Intravaginal Transdermal ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: Oral Injectable Implantable iii. Intrauterine device iv. Intrauterine hormone-releasing system v. Bilateral tubal occlusion vi. Sexual abstinence. In each case of delayed menstrual period (over 1 month between menstruations), confirmation of absence of pregnancy is strongly recommended. This recommendation also applies to women of childbearing potential with infrequent or irregular menstrual cycles.
  • If not surgically sterile, male with female partner of childbearing potential must use condom from signing the ICF through 8 months after the last treatment dose administered. Males must ensure that their partners of childbearing potential use highly effective contraception also.
  • Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures
  • Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

Who cannot join

  • Patients treated with dexamethasone > 2 mg/day or equivalent (i.e., 13 mg/day of prednisone) within 14 days before the first EO2401 administration, unless required to treat an adverse event (AE) Note: The criterion implios the patient should not receive treatment with dexamethasone > 2 mg/day or equivalent at the actual time of a screening visit (single time point assessment), and within 14 days before the first EO2401 administration (unless required to treat AE); the latter part of the criterion should be checked at the time of treatment start.
  • 2. Patients treated with radiotherapy, and cytoreductive therapy within 28 days (6 weeks for nitrosoureas) before the first EO2401 administration. In addition, patients should not have received any prior treatment with compounds targeting PD-1, PD-L1, CTLA-4, or similar compounds where general resistance against therapeutic vaccination approaches might have developed; also, patients should not have received systemic anti-tumor treatment or radiotherapy for their progressive or first recurrent GB.
  • Patients with tumors primarily located in the infra-tentorial segment
  • Patients with known radiological evidence of extracranial metastases
  • Patients with presence of new hemorrhage (excluding, stable Grade 1) or uncontrolled seizure
  • Patients with significant leptomeningeal disease
Show all 46Show fewer
  • Patients with abnormal (≥ Grade 2 National Cancer Institute-Common Terminology Criteria for AEs [NCI-CTCAE] version 5.0) laboratory values for hematology, liver, and renal function (serum creatinine). In detail, the following values apply as exclusion criteria:
  • Hemoglobin < 10 g/dL (6.2 mmol/L)
  • White blood cell count decrease (< 3.0 × 109/L) or increase (> 10.0 × 109/L)
  • Absolute neutrophil count decrease (< 1.5 × 109/L)
  • Platelet count decrease (< 75 × 109/L)
  • Bilirubin > 1.5 × upper limit of normal per local laboratory levels; note, patients with hypothyroidism only requiring hormone replacement therapy are permitted to enroll, also patients with abnormal laboratory values judged by the treating physician as clinically non-relevant.
  • Alanine aminotransferase > 3 × ULN
  • Aspartate aminotransferase > 3 × ULN
  • Serum creatinine increase (> 1.5 × ULN)
  • Abnormal thyroid function
  • For patients who are planned to receive bevacizumab:
  • Patients with nephrotic syndrome
  • Patients with proteinuria ≥ 2g/24 hours
  • Patients with history or active gastrointestinal perforation and fistula
  • Significant surgical procedure in the 4 weeks preceding the start of treatment or planned surgery
  • Unhealed wound
  • Patient with recent (4 weeks) history of hemoptysis of ½ teaspoon or more of red blood
  • Thrombotic episode within 6 months
  • Uncontrolled diabetes mellitus or hypertension
  • Posterior reversible encephalopathy syndrome
  • Patients with persistent Grade 3 or 4 toxicities (according to NCI-CTCAE v5.0). Toxicities must be resolved since at least 2 weeks to Grade 1 or less. However, alopecia or other persisting toxicities Grade ≤ 2 not constituting a safety risk based on Investigator's judgment is acceptable
  • Patients with contraindication to contrast-enhanced MRI
  • Other malignancy or prior malignancy with a disease-free interval of less than 3 years except those treated with surgical intervention and an expected low likelihood of recurrence such as basal cell or squamous cell skin cancer, or carcinoma in situ. Patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ are eligible
  • 12. Patients with clinically significant active infection, cardiac disease, significant medical or psychiatric disease/condition that, in the opinion of the Investigator, would interfere with the evaluation of EO2401 or interpretation of patient safety or study results or that would prohibit the understanding or rendering of informed consent (i.e. only consent able patients can be enrolled in the study) and compliance with the requirements of the protocol - including (but not limited to):
  • Bacterial sepsis or other similarly severe infections
  • New York Heart Association > Grade 2 congestive heart failure within 6 months prior to study entry
  • Uncontrolled or significant cardiovascular disease, including:
  • Myocardial infarction within 6 months prior to obtaining informed consent ii. Uncontrolled/unstable angina within 6 months prior to obtaining informed consent iii. Diagnosed or suspected congenital long QT syndrome iv. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) d. Stroke within 6 months prior obtaining informed consent e. Concurrent neurodegenerative disease f. Dementia or significantly altered mental status.
  • Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barré syndrome) Note, patients with vitiligo, type I diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Patients with history of solid organ transplantation or hematopoietic stem cell transplantation
  • Patients with history or known presence of tuberculosis
  • Pregnant and breastfeeding patients
  • Patients with history or presence of human immunodeficiency virus and/or potentially active hepatitis B virus/hepatitis C virus
  • Patients who have received live or attenuated vaccine therapy used for prevention of infectious diseases including seasonal (influenza) vaccinations within 4 weeks of the first dose of study drug
  • Patients with a history of hypersensitivity to any excipient present in the pharmaceutical form of investigational medicinal product
  • Patients under treatment with immunostimulatory or immunosuppressive medications, including herbal remedies, or herbal remedies known to potentially interfere with major organ function
  • Patients with known drug and alcohol abuse
  • Patients with known or underlying medical or psychiatric condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or AEs
  • Patients who have received treatment with any other investigational agent, or participation in another clinical trial (clinical trial including active interventions are prohibited; participation in clinical trials for data collection purposes only are permitted) within 28 days prior to first study treatment administration and during the treatment period. Note, for investigational agents there should be a wash-out period of at least 28 days, or 5 half-lives if longer, before first study treatment administration
  • Patients deprived of their liberty or under protective custody or guardianship.

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

Germany5 sites

  • Klinik und Poliklinik für Neurologie Universitätsklinikum Bonn

    Bonn, 53105

  • Universitätsklinikum Frankfurt Goethe-Universität Dr. Senckenbergisches Institut für Neuroonkologie

    Frankfurt am Main, 60528

  • Neurologische Klinik & Nationales Zentrum für Tumorenerkrankungen Heidelberg Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Medizinische Fakultät Mannheim der Universität Heidelberg

    Mannheim, 68167

  • Zentrum für Neuroonkologie Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

France2 sites

  • Centre Georges François Leclerc

    Dijon, 21000

  • Hôpital Pitié-Salpétrière

    Paris, 75013

Other trials in France

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Institit Catala D'Oncologia - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 8908

Other trials in Spain

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Multicenter, Open-Label, First-in-Human, Phase 1b/2a Trial of EO2401, a Novel Multipeptide Therapeutic Vaccine, With and Without Check Point Inhibitor, Following Standard Treatment in Patients With Progressive Glioblastoma

The purpose of this study is to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in patients with unequivocal evidence of progressive or first recurrent glioblastoma.

Read the detailed description

This is a multicenter, Phase 1b/2a, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in patients with unequivocal evidence of progressive or first recurrent glioblastoma.

EO2401 is an innovative cancer peptide therapeutic vaccine based on the homologies between Tumor Associated Antigens and microbiome-derived peptides that will be administered alone and in combination with nivolumab, and nivolumab/bevacizumab to generate preliminary safety and efficacy data in patients with progressive glioblastoma.

Being tested
Multiple dose of EO2401
Keywords
Glioblastoma, Vaccine, Nivolumab, Bevacizumab, Safety, Tolerability
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiple dose of EO2401Biological

    Multiple dose administration of EO2401 coadministered with or without nivolumab (and bevacizumab, US only) during the priming phase

Study groups in NCT04116658
Study groupRoleWhat they receive
Cohort 1ExperimentalMultiple dose of EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
Receives: Biological: Multiple dose of EO2401
Cohort 2ExperimentalMultiple dose of EO2041 in combination with nivolumab
Receives: Biological: Multiple dose of EO2401
Cohort 3ExperimentalMultiple dose of EO2041 in combination with nivolumab and bevacizumab
Receives: Biological: Multiple dose of EO2401

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of EO2401 Monotherapy, EO2401 in Combination With Nivolumab , EO2401 in Combination With Nivolumab and Bevacizumab

    Incidences of treatment-emergent Serious Adverse Events ( SAEs) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.

    Measured: From treatment start up to study end, assessed up to 27.5 months

  2. Safety and Tolerability of EO2401 Monotherapy, EO2401 in Combination With Nivolumab , EO2401 in Combination With Nivolumab and Bevacizumab

    Incidences of treatment-emergent AEs (TEAEs) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.

    Measured: From treatment start up to study end, assessed up to 27.5 months

  3. Safety and Tolerability of EO2401 Monotherapy, EO2401 in Combination With Nivolumab , EO2401 in Combination With Nivolumab and Bevacizumab

    Incidences of deaths

    Measured: From treatment start up to study end, assessed up to 44 months

Secondary outcomes (2)

  1. Evaluation of Survival

    Overall survival, defined as the time interval from the date of first study treatment administration to the date of death due to any cause

    Measured: From treatment start up to study end, assessed up to 44 months

  2. Assessment of the Immunogenicity of EO2316, EO2317, EO2318 (Three Components of the Therapeutic Vaccine), and Universal Cancer Peptide That Compose EO2401

    At least one positive response (proof of CD8 T cells specific for the EO2401 mimic peptides and/or for the tumor associated antigen (TAA) target peptides) in either of the used immunomonitoring assays (i.e. CD8 T cell expansion in peripheral blood measured by tetramers/flow cytometry, and Spot-Forming Cells by IFN-γ ELISPOT, both methods applied ex vivo, i.e. without prolonged in vitro stimulation and after in vitro stimulation)

    Measured: 6 weeks after treatment start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2019
  2. Study start13 Jul 2020
  3. Primary completion4 Mar 2024
  4. Study completion4 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04116658
Sponsor's protocol ID
EOGBM1-18
Acronym
ROSALIE
Status last verified
Nov 2025
First submitted
30 Sep 2019
Last updated
28 Nov 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Safety and survival data

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Multiple dose of EO2401 in people with Glioblastoma, Adult, run by Enterome at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, France, Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of EO2401 Monotherapy, EO2401 in Combination With Nivolumab , EO2401 in Combination With Nivolumab and Bevacizumab (time frame: From treatment start up to study end, assessed up to 27.5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04116658.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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