This is a multicenter, Phase 1/2, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma.
EO2401 is an innovative cancer peptide therapeutic vaccine based on the homologies between Tumor Associated Antigens and microbiome-derived peptides that will be administered in combination with nivolumab to generate preliminary safety and efficacy data in patients with Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
MD Anderson Cancer Center
Houston, Texas, United States
Rigshospitalet
Copenhagen, Denmark
Chu Lille
Lille, France
Treatment-Emergent Serious Adverse Events Assessment
Incidences of treatment-emergent serious adverse events using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Time frame: 46 months maximum (from baseline up to study end)
Treatment-Emergent Non-Serious Adverse Events
Incidences of treatment-emergent non-serious adverse events using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Time frame: 46 months maximum (from baseline up to study end)
All Cause Mortalities Assessment
Incidence of death
Time frame: 46 months maximum (from baseline up to study end)
Evaluation of Progression Free Survival
Progression Free Survival according to iRECIST criteria at 6 months
Time frame: 6 months after treatment start
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
Time frame: 46 months maximum (from baseline up to study end)
Percentage of Patients With Immunogenicity Against EO2401
Expansion of specific T cells comparing samples taken at baseline versus on treatment in an individual patient determining if the patient has a positive response to peptides that compose EO2401, or not. EO2401 immunogenicity is assessed by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) (IVS and ex vivo).
Time frame: 7 weeks after treatment start
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre Léon Bérard
Lyon, France
Assistance Publique - Hôpitaux de Marseille - Hôpital Nord
Marseille, France
Institut Gustave Roussy
Villejuif, France
Lmu Klinikum
München, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Azienda Ospedaliera Spedali Civili
Brescia, Italy
Amsterdam UMC, location VUmc
Amsterdam, Netherlands
...and 2 more locations