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

NCT04116658 | Completed Phase 1 Results FDA Drug

• 1 other identifier: EOGBM1-18
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 10

Brief 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.

Conditions

Glioblastoma, Adult

Keywords

Glioblastoma; Vaccine; Nivolumab; Bevacizumab; Safety; Tolerability

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

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

  Incidences of deaths

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

Secondary Outcomes (2)

• Evaluation of Survival

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

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

  6 weeks after treatment start

Study Arms (3)

Cohort 1

EXPERIMENTAL

Multiple dose of EO2041 monotherapy followed by continued EO2401 in combination with nivolumab

Biological: Multiple dose of EO2401

Cohort 2

EXPERIMENTAL

Multiple dose of EO2041 in combination with nivolumab

Biological: Multiple dose of EO2401

Cohort 3

EXPERIMENTAL

Multiple dose of EO2041 in combination with nivolumab and bevacizumab

Biological: Multiple dose of EO2401

Interventions

Multiple dose of EO2401 BIOLOGICAL

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

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• 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:
• a. 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.
• b. 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.

You may not qualify if:

• 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.
• \. 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
• 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

Sponsors & Collaborators

• Enterome: lead
• Covance: collaborator

Study Sites (10)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Centre Georges François Leclerc

Dijon, 21000, France

Location

Hôpital Pitié-Salpétrière

Paris, 75013, France

Location

Klinik und Poliklinik für Neurologie Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Universitätsklinikum Frankfurt Goethe-Universität Dr. Senckenbergisches Institut für Neuroonkologie

Frankfurt am Main, 60528, Germany

Location

Neurologische Klinik & Nationales Zentrum für Tumorenerkrankungen Heidelberg Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Medizinische Fakultät Mannheim der Universität Heidelberg

Mannheim, 68167, Germany

Location

Zentrum für Neuroonkologie Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Institit Catala D'Oncologia - Hospital Duran i Reynals

L'Hospitalet de Llobregat, 8908, Spain

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Jan Fagerberg
• Organization: Enterome

info@enterome.com

+33175772785

Study Officials

• Jean-Michel Paillarse

  Enterome

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 4, 2019
• Study Start: July 13, 2020
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Sep 2025
• Access Criteria: Primary and key secondary outcome measures

Locations

US (1); DE (5); FR (2); ES (2)