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

Completed · Phase 1/Phase 2

Conditions studied: Glioblastoma, Adult

In brief

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.

Key facts

Study ID

NCT04116658

Run by

Enterome

People needed

100

Starts

2020-07-13

Expected to finish

2024-03-04

Last updated by the study team

2025-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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:
• 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.
• 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.

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.
• 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
• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Centre Georges François Leclerc — Dijon, France
• Hôpital Pitié-Salpétrière — Paris, France
• Klinik und Poliklinik für Neurologie Universitätsklinikum Bonn — Bonn, Germany
• Universitätsklinikum Frankfurt Goethe-Universität Dr. Senckenbergisches Institut für Neuroonkologie — Frankfurt am Main, Germany
• Neurologische Klinik & Nationales Zentrum für Tumorenerkrankungen Heidelberg Universitätsklinikum Heidelberg — Heidelberg, Germany
• Medizinische Fakultät Mannheim der Universität Heidelberg — Mannheim, Germany
• Zentrum für Neuroonkologie Universitätsklinikum Tübingen — Tübingen, Germany
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Institit Catala D'Oncologia - Hospital Duran i Reynals — L'Hospitalet de Llobregat, Spain

Full record on ClinicalTrials.gov

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