This study is to find out about the Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

28 Oct 2022 → ongoing

Decision date (initial)

2024-04-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2023-505628-67-00

EudraCT number

2021-000169-34

ClinicalTrials.gov

NCT05409066

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of epcoritamab in combination with lenalidomide and rituximab (R2) compared to R2 alone in participants with relapsed or refractory (R/R) follicular lymphoma (FL).

Secondary objectives 1

1. The secondary objective of this study is to evaluate whether epcoritamab in combination with R2 compared to R2 alone can improve clinical outcomes as measured by key secondary endpoints (including complete response [CR], overall survival [OS], and minimal residual disease [MRD] negativity) in participants with R/R FL.

Conditions and MedDRA coding

Relapsed and Refractory Follicular Lymphoma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
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.
3. 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.
4. 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.)
5. Eligible to receive R2 per investigator determination.

Exclusion criteria 2

1. Documented refractoriness to lenalidomide.
2. Have lenalidomide exposure within 12 months prior to randomization.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Progression-Free Survival (PFS)
2. Best overall response (BOR) of CR or PR, determined by Lugano criteria (Appendix F), as assessed by an Independent Review Committee (IRC)

Secondary endpoints 9

1. Percentage of Participants Achieving Complete Response (CR)
2. Overall Survival (OS)
3. Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity
4. Changes from baseline in Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym).
5. PFS, BOR, and CR during the study, determined per Lugano criteria as assessed by investigator.
6. Duration of response (DOR), duration of complete response (DOCR), time to progression (TTP), and CR at the end of treatment (12 cycles), time to response (TTR), time to complete response (TTCR), per Lugano criteria as assessed by an IRC and by the investigator, respectively.
7. Event-Free Survival (EFS), defined as the duration from randomization to the date of any of the following (whichever occurs first): • Disease progression determined by Lugano criteria as assessed by the investigator • Initiation of any non-protocol-specified new anti lymphoma therapy for any reason • Death
8. Time to next anti-lymphoma treatment (TTNLT).
9. Changes from baseline in Patient-Reported Outcome Instruments (PROs; including Patient Global Impression of Severity [PGIS], Patient Global Impression of Change [PGIC], and EuroQol 5 dimension questionnaire, 5 level [EQ 5D 5L]).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinial Trial Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinial Trial Helpdesk

Third parties 8

Locations

14 EU/EEA countries · 113 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 107 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications