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

STATUS

Recruiting
End date

Dec 30, 2024
participants needed

120
sponsor

Enterome

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Updated on 3 September 2023

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metastatic disease

measurable disease

carcinoma

metastasis

nivolumab

paraganglioma

pheochromocytoma

stage iv adrenocortical cancer

therapeutic vaccine

pheochromocytoma, malignant

adrenal pheochromocytoma

malignant pheochromocytoma

Summary

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.

Description

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.

Details

Condition	Adrenocortical Carcinoma, Pheochromocytoma, Paraganglioma
Treatment	Nivolumab, EO2401
Clinical Study Identifier	NCT04187404
Sponsor	Enterome
Last Modified on	3 September 2023

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