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

NCT04187404 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: EOADR1-19
• Study Type: interventional
• Target: 70
• Locations: 8 countries
• Sites: 12

Brief 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.

Conditions

Adrenocortical Carcinoma; Pheochromocytoma; Paraganglioma

Keywords

adrenocortical carcinoma; pheochromocytoma; paraganglioma

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  46 months maximum (from baseline up to study end)

• All Cause Mortalities Assessment

  Incidence of death

  46 months maximum (from baseline up to study end)

Secondary Outcomes (3)

• Evaluation of Progression Free Survival

  6 months after treatment start

• Evaluation of Survival

  46 months maximum (from baseline up to study end)

• Percentage of Patients With Immunogenicity Against EO2401

  7 weeks after treatment start

Study Arms (4)

5-cohort study design

EXPERIMENTAL

Cohort 1:3-by-3 design of EO2401 in combination with nivolumab at standard dose. Three to 12 evaluable patients with adrenal carcinoma or progressive malignant pheochromocytoma/paraganglioma will be included depending on the safety profile of the administered treatments. Cohorts 2A (previously treated patients) and 2B (previously untreated patients): evaluation of EO2401in combination with nivolumab in 33 patients with adrenal carcinoma. Cohorts 3A (previously treated patients) and 3B (previously untreated patients) : evaluation of EO2401 combination with nivolumab in 20 patients (globally for both Cohorts 3A and 3B) with progressive malignant pheochromocytoma/ paraganglioma.

Biological: EO2401; Biological: Nivolumab

randomized extension of Cohort 2A (3 arms): C2A-I

EXPERIMENTAL

Randomized extension of Cohort 2A (65 patients using a 4:1:1 ratio): 43 patients belonging to this extension of Cohort 2A will be treated by EO2401 and nivolumab in combination.

Biological: EO2401; Biological: Nivolumab

randomized extension of Cohort 2A (3 arms): C2A-II

EXPERIMENTAL

11 patients belonging to this extension of Cohort 2A will be treated by EO2401 alone.

Biological: EO2401

randomized extension of Cohort 2A (3 arms): C2A-III

ACTIVE COMPARATOR

11 patients belonging to this extension of Cohort 2A who will be treated by nivolumab alone.

Biological: Nivolumab

Interventions

EO2401 BIOLOGICAL

Multiple dose of EO2401

5-cohort study design; randomized extension of Cohort 2A (3 arms): C2A-I; randomized extension of Cohort 2A (3 arms): C2A-II

Nivolumab BIOLOGICAL

Multiple dose of nivolumab

5-cohort study design; randomized extension of Cohort 2A (3 arms): C2A-I; randomized extension of Cohort 2A (3 arms): C2A-III

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 with an initial diagnosis of ACC less than 9 months from start of screening part 2.
• 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 with more than three organs involved by disease, combined with unresectable primary tumor.
• 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.

Sponsors & Collaborators

• Enterome: lead

Study Sites (12)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Chu Lille

Lille, 59037, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Assistance Publique - Hôpitaux de Marseille - Hôpital Nord

Marseille, 13915, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Lmu Klinikum

München, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Azienda Ospedaliera Spedali Civili

Brescia, 25121, Italy

Location

Amsterdam UMC, location VUmc

Amsterdam, 1081, Netherlands

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Adrenocortical Carcinoma; Pheochromocytoma; Paraganglioma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jan Fagerberg
• Organization: Enterome

info@enterome.com

+33175772785

Study Officials

• Jean-Michel Paillarse

  Enterome

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: July 23, 2020
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Oct 2025
• Access Criteria: Primary and key secondary outcomes

Locations

DE (2); IT (1); US (1); FR (4); NL (1); SE (1); DK (1); ES (1)