Open Phase III study to assess the safety and efficacy of Epcoritamab in combination with Rituximab and Lenalidomide (R2) compared to R2 in participants with relapsed or refractory follicular lymphoma (EPCORE FL-1)
Summary description of the study
This study investigates how safe and effective Epcoritamab in combination with Lenalidomide and Rituximab (R2) is in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and changes in disease status are being investigated. Epcoritamab is an investigational drug being developed for the treatment of FL. Study participants will be randomly assigned to 1 of 3 groups known as treatment arms. Each group will receive a different treatment. Approximately 642 adult participants with R/R FL will be enrolled at around 300 study centers worldwide.
(BASEC)
Intervention under investigation
Study participants will receive R2 (intravenous infusion of Rituximab for up to 5 cycles and oral Lenalidomide capsules for up to 12 cycles) alone or in combination with subcutaneous injections of Epcoritamab for up to 12 cycles. Each cycle lasts 28 days.
(BASEC)
Disease under investigation
Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is not curable with conventional treatment, and nearly all patients experience a recurrence of the disease.
(BASEC)
- ECOG Performance Status of 0 to 2 - Histologically confirmed FL of grades 1 to 3a without evidence of histological transformation to aggressive lymphoma at the last representative tumor biopsy and CD20+ at a representative tumor biopsy according to the pathology report - Relapsed or refractory (R/R) disease to at least one prior systemic treatment that included a monoclonal anti-CD20 antibody in combination with (a) other anti-lymphoma agent(s) - Study participant has one or more measurable disease lesions: • FDG-PET with positive findings compatible with the anatomical tumor lesions defined on CT or MRI AND • ≥ 1 measurable nodal lesion (long axis ≥ 1.5 cm and short axis > 1.0 cm) or ≥ 1 measurable extra-nodal lesion (long axis ≥ 1.0 cm) on CT or MRI. - Study participant must be eligible for treatment with R2 as assessed by the investigator. (BASEC)
Exclusion criteria
- Documented refractoriness to Lenalidomide. - A Lenalidomide treatment within 12 months prior to randomization. (BASEC)
Trial sites
Aarau, Bellinzona, Chur, St. Gallen
(BASEC)
Sponsor
AbbVie AG Cham
(BASEC)
Contact
Contact Person Switzerland
AbbVie Medical Information
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie AG
(BASEC)
General Information
AbbVie
(ICTRP)
Scientific Information
AbbVie
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
15.09.2022
(BASEC)
ICTRP Trial ID
NCT05409066 (ICTRP)
Official title (approved by ethics committee)
A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1) (BASEC)
Academic title
A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1) (ICTRP)
Public title
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma (ICTRP)
Disease under investigation
Follicular Lymphoma (FL) (ICTRP)
Intervention under investigation
Drug: EpcoritamabDrug: RituximabDrug: Lenalidomide (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
- Participant has:
- Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating
positive lesion compatible with computed tomography (CT) or magnetic resonance
image (MRI)-defined anatomical tumor sites AND
- >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable
extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
- Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a
FL] stage II, III, or IV with no evidence of histologic transformation to an
aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy
based on the pathology report.
- Relapsed or refractory (R/R) disease to at least one prior systemic regimen that
contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy.
(Participant who received only prior anti-CD20 mAb monotherapy and/or radiation
therapy is not eligible.)
- Eligible to receive R2 per investigator determination.
- Estimated Creatinine Clearance (CrCl) >= 50 mL/min.
Exclusion Criteria:
- Documented refractoriness to lenalidomide.
- Have lenalidomide exposure within 12 months prior to randomization. (ICTRP)
not available
Primary and secondary end points
Percentage of Participants Achieving Best Overall Response (BOR);Progression-Free Survival (PFS) (ICTRP)
Time to next anti-lymphoma treatment (TTNLT);Change in Patient's Global Impression of Severity (PGIS);Change in Patient's Global Impression of Change (PGIC);Change in EuroQol 5-Dimension Questionnaire, 5-level (EQ-5D-5L);Percentage of Participants Achieving CR;Overall Survival (OS);Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity;Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym);PFS as Assessed by Investigator;Percentage of Participants Achieving BOR as Assessed by Investigator;Percentage of Participants Achieving CR as Assessed by Investigator;Duration of Response (DOR);Duration of Complete Response (DOCR);Time to Progression (TTP);Time to Next Anti-Lymphoma Treatment (TTNLT);Percentage of Participants Achieving CR at the End of Treatment;Time to Response (TTR);Time to Complete Response (TTCR);Event-Free Survival (EFS) (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
AbbVie (ICTRP)
Additional contacts
ABBVIE INC., AbbVie (ICTRP)
Secondary trial IDs
2023-505628-67, M20-638 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05409066 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available