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A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma (SIDNEY)

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ClinicalTrials.gov Identifier: NCT04669171
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Enterome

Brief Summary:
The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent NHL

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Marginal Zone Lymphoma Biological: EO2463 Drug: lenalidomide Biological: rituximab Phase 1 Phase 2

Detailed Description:
EO2463 Is an innovative cancer peptide therapeutic vaccine based on the homologies between tumor associated antigens and microbiome-derived peptides that will be administered alone and in combination with lenalidomide, rituximab, and lenalidomide/rituximab to generate safety and preliminary efficacy data in patients with indolent NHL

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Global Multicenter Phase 1/2 Trial of EO2463, a Novel Microbial-Derived Peptide Therapeutic Vaccine, as Monotherapy, and in Combination With Lenalidomide and Rituximab, for Treatment of Patients With Indolent Non-Hodgkin's Lymphoma
Actual Study Start Date : July 5, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2029


Arm Intervention/treatment
Experimental: Cohort 1
Safety Lead-In, Dose-Finding, Cohort, with a 3-by-3 design of EO2463 for 6 weeks followed by addition of lenalidomide week 7 and rituximab week 19 (depending on response). Four to 18 evaluable (previously treated) patients with Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) will be Included based on safety findings
Biological: EO2463
Multiple dose of EO2463

Drug: lenalidomide
D1-21 of 4-weekly cycles
Other Name: Revlimid

Biological: rituximab
Multiple doses of rituximab
Other Name: MabThera

Experimental: Cohort 2
15 Previously untreated patients with FL Or MZL. Evaluation of EO2463 monotherapy at the established dose in Cohort 1
Biological: EO2463
Multiple dose of EO2463

Experimental: Cohort 3
15 Previously untreated patients with FL or MZL. Evaluation of EO2463 at the established dose in cohort 1 as monotherapy for 6 weeks and in combination with rituximab from week 7
Biological: EO2463
Multiple dose of EO2463

Biological: rituximab
Multiple doses of rituximab
Other Name: MabThera

Experimental: Cohort 4
15 Previously treated patients with FL Or MZL. Evaluation of EO2463 at the established dose in Cohort 1 in combination with lenalidomide and with addition of rituximab from week 19 onwards (depending on response)
Biological: EO2463
Multiple dose of EO2463

Drug: lenalidomide
D1-21 of 4-weekly cycles
Other Name: Revlimid

Biological: rituximab
Multiple doses of rituximab
Other Name: MabThera




Primary Outcome Measures :
  1. Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment | [ Time Frame: Up to 24 months ]
    Incidences of adverse events, Treatment-Emergent Adverse events, Serious Adverse Events, Deaths, and Laboratory Abnormalities Using the National Cancer Institute-Common Terminology Criteria for Adverse events (NCI-CTCAE) V5.0.

  2. Phase 2: Overall Response Rate [ Time Frame: Up to 24 months ]
    Overall Response Rate According to the Lugano Classification 2014 during EO2463 Monotherapy


Secondary Outcome Measures :
  1. Safety and Tolerability for EO2463 Administered as Monotherapy and in Combination with Lenalidomide, Rituximab and Lenalidomide/Rituximab [ Time Frame: Up to 24 months ]
    Incidences Of Adverse Events, Treatment-Emergent Adverse events, Serious Adverse events, Deaths, Treatment Discontinuations/Delays, And Laboratory Abnormalities Using The NCI-CTCAE V5.0 Grading System

  2. Assessment of the Immunogenicity in Relation to OMP72, OMP64, OMP65, OMP66, and UCP2 that Compose EO2463 [ Time Frame: Up to 24 months ]
    Immunogenicity will be assessed by interferon-Gamma (IFN-Γ) enzyme-Linked immunospot , and by intracellular cytokines staining, and multimers staining assays

  3. Overall Response Rate [ Time Frame: Up to 24 months ]
    Overall Response Rate as described by the Lugano Classification 2014, and by the Lymphoma Response to Immunomodulatory Therapy Criteria (Lyric) 2016 by trial cohort

  4. Duration of response [ Time Frame: Up to 7 years after last patient enrolled ]
    Duration of Response as described by the Lugano Classification 2014, and by the Lymphoma Response to Immunomodulatory Therapy Criteria (Lyric) 2016 by trial cohort

  5. Evaluation of Overall Survival [ Time Frame: Up to 7 years after last patient enrolled ]
    The time interval from the date of first study treatment administration to the date of death due to any cause



Information from the National Library of Medicine

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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. For inclusion in Cohorts 1 and 4 patients should have relapsed/refractory, biopsy-proven grade 1, 2 or 3A, FL or MZL, ECOG performance status 0 to 2, and have received at least one prior line of treatment.
  2. For inclusion in Cohort 2 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, and not be in need of standard of care therapy according to the assessment of the treating physician.
  3. Patients with only one prior treatment and a high-risk profile as defined by first progression of disease within 24 months of diagnosis (the exclusion is not applicable for patients with more than one prior line treatment).
  4. For inclusion in Cohort 3 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, low tumor burden by Groupe d'Etude des Lymphomes Folliculaires criteria and be in need of therapy according to the assessment of the treating physician.
  5. Patients with an age ≥ 18 years old.
  6. Patients who are human leukocyte antigen (HLA)-A2 positive.
  7. Patients should have radiologically measurable disease with a lymph node or tumor mass greater than or equal to 1.5 cm in at least one dimension.
  8. Males or non-pregnant, non-lactating, females.
  9. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
  10. Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures.

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 EO2463 administration, unless required to treat an adverse event.
  2. Patients with grade 3B FL or transformation to an aggressive lymphoma subtype.
  3. Patients with only one prior treatment and a high-risk profile as defined by first progression of disease within 24 months of diagnosis (the exclusion is not applicable for patients with more than one prior line treatment).
  4. Patients with prior exposure to EO2463.
  5. 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 EO2463 administration.
  6. Patients to be included in Cohorts 1 and 4, and who have received rituximab or other B cell ablation therapy within 8 weeks of start of study treatment.
  7. Patients with abnormal laboratory values.
  8. Patients with persistent Grade 3 or 4 toxicities.
  9. Uncontrolled central nervous system (CNS) metastasis.
  10. Other malignancy or prior malignancy with a disease-free interval of less than 3 years.
  11. Patients with clinically significant disease.
  12. Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome).
  13. Patients with history of solid organ transplantation or hematopoietic stem cell transplantation.
  14. Pregnant and breastfeeding patients.
  15. Patients with history or presence of human immunodeficiency virus and/or potentially active hepatitis B virus/hepatitis C virus infection.

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): NCT04669171


Contacts
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Contact: Jan Fagerberg, MD, PhD +32 3 205 55 55 medicalmonitoring-hem@enterome.com
Contact: Karlijn Kroon, MD +33 611300589 kkroon-ext@enterome.com

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Reid Merryman, Dr         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jose Caetano Villasboas Bisneto, Dr         
United States, New York
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) Recruiting
Rochester, New York, United States, 14642
Contact: Jonathan Friedberg, Dr         
United States, Washington
University of Washington-Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Stephen Smith, Dr         
Italy
University of Bologna Active, not recruiting
Bologna, Italy
IRCCS Policlinico San Matteo Foundation - University of Pavia Recruiting
Naples, Italy
Contact: Antonio Pinto, Dr         
IRCCS Policlinico San Matteo Foundation - University of Pavia Recruiting
Pavia, Italy
Contact: Luca Arcaini, Dr         
Spain
University Hospital Vall d'Hebron, Institute of Oncology Recruiting
Barcelona, Spain
Contact: Francisco Bosch Albareda, Dr         
Clinica Universidad de Navarra Recruiting
Madrid, Spain
Contact: Carlos Grande, Dr         
Hospital Clinico Universitario de Salamanca Recruiting
Salamanca, Spain
Contact: Ramon Garcia Sanz, Dr         
Sponsors and Collaborators
Enterome
Investigators
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Study Director: Jan Fagerberg, MD Enterome
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Responsible Party: Enterome
ClinicalTrials.gov Identifier: NCT04669171    
Other Study ID Numbers: EONHL1-20
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Enterome:
Follicular Lymphoma
Marginal Zone Lymphoma
Rituximab
Lenalidomide
Vaccine
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Rituximab
Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors