A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma (Spencer)

  • End date
    Dec 30, 2024
  • participants needed
  • sponsor
Updated on 3 September 2023
metastatic disease
measurable disease
stage iv adrenocortical cancer
therapeutic vaccine
pheochromocytoma, malignant
adrenal pheochromocytoma
malignant pheochromocytoma


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.

Condition Adrenocortical Carcinoma, Pheochromocytoma, Paraganglioma
Treatment Nivolumab, EO2401
Clinical Study IdentifierNCT04187404
Last Modified on3 September 2023


Yes No Not Sure

Inclusion Criteria

For inclusion in Cohort 1 patients should have adrenocortical carcinoma(ACC), or malignant pheochromocytoma/paraganglioma (MPP), as defined below for Cohorts 2A and 3A
For inclusion in Cohorts 2A and 2B patients should have histologically confirmed (at primary diagnosis) unresectable locally advanced or metastatic adrenocortical carcinoma
For inclusion in Cohorts 3A and 3B patients should have histologically confirmed (at primary diagnosis) unresectable malignant (defined as metastatic disease, i.e. presence of chromaffin tissue in non-chromaffin organs) pheochromocytoma/paraganglioma, and RECIST defined progression should have been documented during a maximum of an 18-months period
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 ≤ 1
Patients with a life expectancy > 4 months as judged by their treating physician
Patients with at least one measurable lesion according to RECIST 1.1
Males or non-pregnant, non-lactating, females
Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol
Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures

Exclusion Criteria

Patients treated with dexamethasone > 2 mg/day or equivalent (i.e. 13 mg/day of prednisone, or 53 mg/day of hydrocortisone) within 14 days before the first EO2401 administration, unless required to treat an adverse event
Patients with prior treatment with immune check-point inhibitors
Patients with prior exposure to EO2401
Patients treated with immunotherapy (meaning immunostimulatory or immunosuppressive therapy; beside excluded, or allowed, compounds per other inclusion/exclusion criteria specifications), radionuclide therapy, radiotherapy, cytoreductive therapy, or received treatment with any other investigational agent within 28 days before the first EO2401 administration
Patients with an initial diagnosis of ACC less than 9 months from start of screening part 2
Patients with ACC with more than three organs involved by disease, combined with unresectable primary tumor
Patients with ACC and any individual lesion according to RECIST 1.1 having a maximum diameter of more than 125 mm; irrespective if the lesion is proposed as a target lesion, or not, according to RECIST 1.1
Patients with ACC and uncontrolled hormonal secretion (according to the judgement of the treating physician)
Patients with MPP and uncontrolled blood pressure (according to the judgement of the treating physician)
Patients with abnormal laboratory values
Patients with persistent Grade 3 or 4 toxicities
Uncontrolled central nervous system (CNS) metastasis
Other malignancy or prior malignancy with a disease-free interval of less than 3 years
Patients with clinically significant disease
Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome)
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 infection
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 forms of the study treatments
Patients treated with herbal remedies with immunostimulating properties or known to potentially interfere with major organ function
Patients with known ongoing 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 deprived of their liberty, under protective custody, or guardship
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