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Experimental vaccine combo for rare adrenal cancers shows early promise but trial halted

NCT ID NCT04187404

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested a new therapeutic vaccine (EO2401) combined with the immunotherapy drug nivolumab in 70 people with advanced adrenocortical carcinoma or malignant pheochromocytoma/paraganglioma. The goal was to see if the combination is safe and can shrink tumors or slow cancer growth. However, the study was terminated early, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EO2401 (therapeutic vaccine) and nivolumab (immunotherapy)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced adrenal cancers that are hard to treat.
What could go wrong
The trial was terminated early, so results are limited. It is a small, early-phase study, and the vaccine may not work or may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

70 people

The number who actually took part.

Started

Jul 2020

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: 1. For inclusion in Cohort 1 patients should have adrenocortical carcinoma(ACC), or malignant pheochromocytoma/paraganglioma (MPP), as defined below for Cohorts 2A and 3A. 2. For inclusion in Cohorts 2A and 2B patients should have histologically confirmed (at primary diagnosis) unresectable locally advanced or metastatic adrenocortical carcinoma. 3. 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. 4. Patients with an age ≥ 18 years old. 5. Patients who are human leukocyte antigen (HLA)-A2 positive. 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 7. Patients with a life expectancy \> 4 months as judged by their treating physician. 8. Patients with at least one measurable lesion according to RECIST 1.1. 9. Males or non-pregnant, non-lactating, females. 10. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol. 11. Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures. Main Exclusion Criteria: 1. 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. 2. Patients with prior treatment with immune check-point inhibitors 3. Patients with prior exposure to EO2401. 4. 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. 5. Patients with an initial diagnosis of ACC less than 9 months from start of screening part 2. 6. 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. 7. Patients with ACC with more than three organs involved by disease, combined with unresectable primary tumor. 8. Patients with ACC and uncontrolled hormonal secretion (according to the judgement of the treating physician). 9. Patients with MPP and uncontrolled blood pressure (according to the judgement of the treating physician). 10. Patients with abnormal laboratory values. 11. Patients with persistent Grade 3 or 4 toxicities. 12. Uncontrolled central nervous system (CNS) metastasis. 13. Other malignancy or prior malignancy with a disease-free interval of less than 3 years 14. Patients with clinically significant disease. 15. Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome). 16. Patients with history of solid organ transplantation or hematopoietic stem cell transplantation. 17. Patients with history or known presence of tuberculosis. 18. Pregnant and breastfeeding patients. 19. Patients with history or presence of human immunodeficiency virus and/or potentially active hepatitis B virus/hepatitis C virus infection. 20. 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. 21. Patients with a history of hypersensitivity to any excipient present in the pharmaceutical forms of the study treatments. 22. Patients treated with herbal remedies with immunostimulating properties or known to potentially interfere with major organ function. 23. Patients with known ongoing drug and alcohol abuse. 24. 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. 25. Patients deprived of their liberty, under protective custody, or guardship.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Amsterdam UMC, location VUmc

    Amsterdam, 1081, Netherlands

  • Assistance Publique - Hôpitaux de Marseille - Hôpital Nord

    Marseille, 13915, France

  • Azienda Ospedaliera Spedali Civili

    Brescia, 25121, Italy

  • Centre Léon Bérard

    Lyon, 69008, France

  • Chu Lille

    Lille, 59037, France

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Karolinska University Hospital

    Stockholm, 17176, Sweden

  • Lmu Klinikum

    München, Germany

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

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