Experimental vaccine combo for rare adrenal cancers shows early promise but trial halted
NCT ID NCT04187404
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adrenocortical carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a nudge in your chart unlock Life-Saving genetic clues?
- Can a radioactive 'Smart Bomb' take down resistant childhood cancers?
- Can a new drug shrink Hard-to-Treat adrenal tumors?
- Can a radioated molecule shrink untreatable neuroblastoma?
- Liver tumors targeted directly: old pump, new drug
- New drug aims to shrink rare adrenal tumors