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

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ClinicalTrials.gov Identifier: NCT04187404
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : August 25, 2023
Sponsor:
Information provided by (Responsible Party):
Enterome

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adrenocortical Carcinoma Pheochromocytoma Paraganglioma Biological: EO2401 Biological: Nivolumab Phase 1 Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Trial of a Novel Therapeutic Vaccine (EO2401) in Combination With Immune Check Point Blockade, for Treatment of Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pheochromocytoma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Biological: EO2401
Multiple dose of EO2401

Biological: Nivolumab
Multiple dose of nivolumab
Experimental: 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.
 Biological: EO2401
Multiple dose of EO2401

Biological: Nivolumab
Multiple dose of nivolumab
Experimental: randomized extension of Cohort 2A (3 arms): C2A-II
11 patients belonging to this extension of Cohort 2A will be treated by EO2401 alone.
 Biological: EO2401
Multiple dose of EO2401
Active Comparator: 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.
 Biological: Nivolumab
Multiple dose of nivolumab


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events assessment [ Time Frame: Up to 24 months ]
    Incidences of adverse events(AEs), treatment-emergent AEs (TEAEs), Serious Adverse Events ( SAEs), deaths, and laboratory abnormalities using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.


Secondary Outcome Measures :
  1. Evaluation of Progression Free Survival at 6 months [ Time Frame: 6 months after first treatment date from the last patient enrolled ]
    Progression Free Survival according to iRECIST criteria defined as the time interval from the date of first study treatment administration to 6 months after

  2. Evaluation of survival [ Time Frame: From end of treatment to at least 24 months after last patient enrollment ]
    Overall survival, defined as the time interval from the date of first study treatment administration to the date of death due to any cause

  3. Assessment of the immunogenicity [ Time Frame: Up to 24 months ]
    Assessment of the immunogenicity of the 4 components that compose EO2401 Immunogenicity will be assessed by Interferon-γ ELISpot


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187404


Contacts
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Contact: Jean-Michel Paillarse +32 3 205 55 55 medicalmonitoring@enterome.com

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Vivek Subbiah, MD       VSubbiah@mdanderson.org   
Principal Investigator: Vivek Subbiah         
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Kirsten Gedske Daugaard, MD       kirsten.gedske.daugaard@regionh.dk   
Principal Investigator: Kirsten Gedske Daugaard         
France
Chu Lille Recruiting
Lille, France, 59037
Contact: Christine Do Cao, MD       christine.docao@chu-lille.fr   
Centre Léon Bérard Recruiting
Lyon, France, 69008
Contact: Christelle de la Fouchardière, MD       christelle.delafouchardiere@lyon.unicancer.fr   
Principal Investigator: Christelle de la Fouchardière         
Assistance Publique - Hôpitaux de Marseille - Hôpital Nord Recruiting
Marseille, France, 13915
Contact: Marie-Eve Garcia, MD       marie-eve.garcia@ap-hm.fr   
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Principal Investigator: Eric Baudin, MD         
Germany
Lmu Klinikum Recruiting
München, Germany
Contact: Matthias Kroiß, MD       Matthias.Kroiss@med.uni-muenchen.de   
Principal Investigator: Matthias Kroiß         
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany, 97080
Principal Investigator: Martin Fassnacht, MD         
Italy
Azienda Ospedaliera Spedali Civili Recruiting
Brescia, Italy, 25121
Contact: Salvatore Grisanti, MD         
Contact       salvatore.grisanti@tin.it   
Principal Investigator: Salvatore Grisanti         
Netherlands
Amsterdam UMC, location VUmc Recruiting
Amsterdam, Netherlands, 1081
Contact: Catharina Willemien Menke - van der Houven van Oordt, MD       c.menke@amsterdamumc.nl   
Principal Investigator: Catharina Willemien Menke - van der Houven van Oordt         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Jaume Capdevilla, MD       jcapdevila@vhio.net   
Principal Investigator: Jaume Capdevila         
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Dan Granberg, MD       dan.granberg1954@icloud.com   
Principal Investigator: Dan Granberg         
Sponsors and Collaborators
Enterome
Investigators
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Study Director: Jean-Michel Paillarse Enterome
More Information
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Responsible Party: Enterome
ClinicalTrials.gov Identifier: NCT04187404    
Other Study ID Numbers: EOADR1-19
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: August 25, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enterome:
adrenocortical carcinoma
pheochromocytoma
paraganglioma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma
Pheochromocytoma
Paraganglioma
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adenocarcinoma
 Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action