First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progress… (NCT04116658) | Clinical Trial Compass
CompletedPhase 1/2
First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma
United States, France, Germany100 participantsStarted 2020-07-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 :
✓. 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)
Exclusion criteria
✕. 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.
What they're measuring
1
Safety and Tolerability of EO2401 Monotherapy, EO2401 in Combination With Nivolumab , EO2401 in Combination With Nivolumab and Bevacizumab
Timeframe: 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
Timeframe: 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
Timeframe: From treatment start up to study end, assessed up to 44 months
✕. 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: