A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma
NCT ID: NCT04187404
Last Updated: 2026-01-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2020-07-23
2024-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5-cohort study design
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.
EO2401
Multiple dose of EO2401
Nivolumab
Multiple dose of nivolumab
randomized extension of Cohort 2A (3 arms): C2A-I
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.
EO2401
Multiple dose of EO2401
Nivolumab
Multiple dose of nivolumab
randomized extension of Cohort 2A (3 arms): C2A-II
11 patients belonging to this extension of Cohort 2A will be treated by EO2401 alone.
EO2401
Multiple dose of EO2401
randomized extension of Cohort 2A (3 arms): C2A-III
11 patients belonging to this extension of Cohort 2A who will be treated by nivolumab alone.
Nivolumab
Multiple dose of nivolumab
Interventions
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EO2401
Multiple dose of EO2401
Nivolumab
Multiple dose of nivolumab
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
2. Patients with prior treatment with immune check-point inhibitors
3. Patients with prior exposure to EO2401.
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.
18 Years
ALL
No
Sponsors
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Enterome
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Michel Paillarse
Role: STUDY_DIRECTOR
Enterome
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Rigshospitalet
Copenhagen, , Denmark
Chu Lille
Lille, , France
Centre Léon Bérard
Lyon, , France
Assistance Publique - Hôpitaux de Marseille - Hôpital Nord
Marseille, , France
Institut Gustave Roussy
Villejuif, , France
Lmu Klinikum
München, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Azienda Ospedaliera Spedali Civili
Brescia, , Italy
Amsterdam UMC, location VUmc
Amsterdam, , Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Karolinska University Hospital
Stockholm, , Sweden
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EOADR1-19
Identifier Type: -
Identifier Source: org_study_id
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