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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06191744




Registration number
NCT06191744
Ethics application status
Date submitted
20/12/2023
Date registered
5/01/2024

Titles & IDs
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 Previously Untreated Follicular Lymphoma
Scientific title
A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
Secondary ID [1] 0 0
2023-506906-38-00
Secondary ID [2] 0 0
M22-003
Universal Trial Number (UTN)
Trial acronym
EPCORE™FL-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma (FL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Epcoritamab
Treatment: Drugs - Prednisone
Treatment: Drugs - Rituximab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Bendamustine

Experimental: Arm A: Epcoritamab + Lenalidomide and Rituximab (R2) - Participants will receive epcoritamab in combination with R2 during the 120 week treatment duration.

Experimental: Arm B: Chemoimmunotherapy (CIT) Option A - Participants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.

Experimental: Arm B: Chemoimmunotherapy (CIT) Option B - Participants will receive CIT Option B (G and bendamustine (Benda) \[G-Benda\]/R-Benda during the 120 week treatment duration.

Experimental: Arm C: Lenalidomide and Rituximab (R2) - Participants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.


Treatment: Drugs: Epcoritamab
Subcutaneous (SC) Injection

Treatment: Drugs: Prednisone
Oral Tablet

Treatment: Drugs: Rituximab
Intravenous (IV) Infusion

Treatment: Drugs: Lenalidomide
Oral Capsule

Treatment: Drugs: Doxorubicin
IV Injection

Treatment: Drugs: Vincristine
IV Injection

Treatment: Drugs: Cyclophosphamide
IV Injection

Treatment: Drugs: Obinutuzumab
IV Infusion

Treatment: Drugs: Bendamustine
IV Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Arm A vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
Timepoint [1] 0 0
Up to 30 Months
Primary outcome [2] 0 0
Arm A vs Arm B: Number of Participants with Progression-free survival (PFS)
Timepoint [2] 0 0
Up to 10 Years
Secondary outcome [1] 0 0
Arm A vs Arm B: Overall Survival (OS)
Timepoint [1] 0 0
Up to 10 Years
Secondary outcome [2] 0 0
Arm A vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate
Timepoint [2] 0 0
Up to 10 Years
Secondary outcome [3] 0 0
Arm A vs Arm B: Percentage of Participants who Maintain Physical Functioning (PF) According to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30)
Timepoint [3] 0 0
25 Weeks
Secondary outcome [4] 0 0
Arm A vs Arm C: Percentage of Participants who Achieve CR30
Timepoint [4] 0 0
Up to 30 Months
Secondary outcome [5] 0 0
Arm A vs Arm C: Number of Participants with PFS
Timepoint [5] 0 0
Up to 10 Years
Secondary outcome [6] 0 0
Arm A vs Arm C: OS
Timepoint [6] 0 0
Up to 10 Years
Secondary outcome [7] 0 0
Arm A vs Arm C: Rate of MRD Negativity
Timepoint [7] 0 0
Up to 10 Years
Secondary outcome [8] 0 0
Arm A vs Arm C: Percentage of Participants who Maintain PF According to EORTC QLQ-C30
Timepoint [8] 0 0
Up to 10 Years
Secondary outcome [9] 0 0
Arm A vs Arm B: Percentage of Participants who Achieve CR30
Timepoint [9] 0 0
Up to 30 Months
Secondary outcome [10] 0 0
Arm A vs Arm C: Percentage of Participants who Achieve CR30
Timepoint [10] 0 0
Up to 30 Months
Secondary outcome [11] 0 0
Arm A vs Arm C: Number of Participants with PFS
Timepoint [11] 0 0
Up to 10 Years
Secondary outcome [12] 0 0
Arm A vs Arm B: Percentage of Participants with Change in CR Rate per IRC
Timepoint [12] 0 0
Up to 10 Years
Secondary outcome [13] 0 0
Arm A vs Arm C: Percentage of Participants with Change in CR Rate per IRC
Timepoint [13] 0 0
Up to 10 Years
Secondary outcome [14] 0 0
Arm A vs Arm B: Percentage of Participants with Change in CR Rate per Investigator
Timepoint [14] 0 0
Up to 10 Years
Secondary outcome [15] 0 0
Arm A vs Arm C: Percentage of Participants with Change in CR Rate per Investigator
Timepoint [15] 0 0
Up to 10 Years
Secondary outcome [16] 0 0
Arm A vs Arm B: Number of Participants with Best Overall Response (BOR) per per Investigator
Timepoint [16] 0 0
Up to 10 Years
Secondary outcome [17] 0 0
Arm A vs Arm C: Number of Participants with BOR per Investigator
Timepoint [17] 0 0
Up to 10 Years
Secondary outcome [18] 0 0
Arm A vs Arm B: Number of Participants with BOR per IRC
Timepoint [18] 0 0
Up to 10 Years
Secondary outcome [19] 0 0
Arm A vs Arm C: Number of Participants with BOR per IRC
Timepoint [19] 0 0
Up to 10 Years
Secondary outcome [20] 0 0
Arm A vs Arm B: Number of Participants with Event-free Survival (EFS) per IRC
Timepoint [20] 0 0
Up to 10 Years
Secondary outcome [21] 0 0
Arm A vs Arm C: Number of Participants with EFS per IRC
Timepoint [21] 0 0
Up to 10 Years
Secondary outcome [22] 0 0
Arm A vs Arm B: Number of Participants with EFS per Investigator
Timepoint [22] 0 0
Up to 10 Years
Secondary outcome [23] 0 0
Arm A vs Arm C: Number of Participants with EFS per Investigator
Timepoint [23] 0 0
Up to 10 Years
Secondary outcome [24] 0 0
Arm A vs Arm B: Duration of Response (DOR) per IRC
Timepoint [24] 0 0
Up to 10 Years
Secondary outcome [25] 0 0
Arm A vs Arm C: DOR per IRC
Timepoint [25] 0 0
Up to 10 Years
Secondary outcome [26] 0 0
Arm A vs Arm B: DOR per Investigator
Timepoint [26] 0 0
Up to 10 Years
Secondary outcome [27] 0 0
Arm A vs Arm C: DOR per Investigator
Timepoint [27] 0 0
Up to 10 Years
Secondary outcome [28] 0 0
Arm A vs Arm B: Duration of Complete Response (DOCR) per IRC
Timepoint [28] 0 0
Up to 10 Years
Secondary outcome [29] 0 0
Arm A vs Arm C: DOCR per IRC
Timepoint [29] 0 0
Up to 10 Years
Secondary outcome [30] 0 0
Arm A vs Arm B: DOCR per Investigator
Timepoint [30] 0 0
Up to 10 Years
Secondary outcome [31] 0 0
Arm A vs Arm C: DOCR per Investigator
Timepoint [31] 0 0
Up to 10 Years
Secondary outcome [32] 0 0
Arm A vs Arm B: Time to Next Anti-lymphoma Therapy (TTNT)
Timepoint [32] 0 0
Up to 10 Years
Secondary outcome [33] 0 0
Arm A vs Arm C: TTNT
Timepoint [33] 0 0
Up to 10 Years
Secondary outcome [34] 0 0
Arm A vs Arm B: Time to Progression per IRC
Timepoint [34] 0 0
Up to 10 Years
Secondary outcome [35] 0 0
Arm A vs Arm C: Time to Progression per IRC
Timepoint [35] 0 0
Up to 10 Years
Secondary outcome [36] 0 0
Arm A vs Arm B: Time to Progression per Investigator
Timepoint [36] 0 0
Up to 10 Years
Secondary outcome [37] 0 0
Arm A vs Arm C: Time to Progression per Investigator
Timepoint [37] 0 0
Up to 10 Years
Secondary outcome [38] 0 0
Arm A vs Arm B: Number of Participants with Progression-free Survival After Subsequent Anti-Lymphoma Therapy (PFS2)
Timepoint [38] 0 0
Up to 10 Years
Secondary outcome [39] 0 0
Arm A vs Arm C: Number of Participants with PFS2
Timepoint [39] 0 0
Up to 10 Years
Secondary outcome [40] 0 0
Arm A vs Arm B: Change in Tolerability as Measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [40] 0 0
Up to 10 Years
Secondary outcome [41] 0 0
Arm A vs Arm C: Change in Tolerability as Measured by PRO-CTCAE
Timepoint [41] 0 0
Up to 10 Years
Secondary outcome [42] 0 0
Arm A vs Arm B: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy Singly Item - GP5 (FACT-GP5)
Timepoint [42] 0 0
Up to 10 Years
Secondary outcome [43] 0 0
Arm A vs Arm C: Change in Tolerability as Measured by FACT-GP5
Timepoint [43] 0 0
Up to 10 Years
Secondary outcome [44] 0 0
Arm A vs Arm B: Change in Symptoms as Measured by The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Timepoint [44] 0 0
Up to 10 Years
Secondary outcome [45] 0 0
Arm A vs Arm C: Change in Symptoms as Measured by FACT-Lym
Timepoint [45] 0 0
Up to 10 Years
Secondary outcome [46] 0 0
Arm A vs Arm B: Change in Quality of Life (QoL) as Measured by FACT-Lym
Timepoint [46] 0 0
Up to 10 Years
Secondary outcome [47] 0 0
Arm A vs Arm C: Change in QoL as Measured by FACT-Lym
Timepoint [47] 0 0
Up to 10 Years
Secondary outcome [48] 0 0
Arm A vs Arm B: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L]
Timepoint [48] 0 0
Up to 10 Years
Secondary outcome [49] 0 0
Arm A vs Arm C: Change in QoL as Measured by EQ-5D-5L
Timepoint [49] 0 0
Up to 10 Years
Secondary outcome [50] 0 0
Arm A vs Arm B: Change in Participant Belief in in Efficacy of Treatment as Measured by Patient Global Impression of Change (PGIC)
Timepoint [50] 0 0
Up to 10 Years
Secondary outcome [51] 0 0
Arm A vs Arm C: Change in Participant Belief in in Efficacy of Treatment as Measured by PGIC
Timepoint [51] 0 0
Up to 10 Years
Secondary outcome [52] 0 0
Arm A vs Arm B: Change in Participant Belief in in Efficacy of Treatment as Measured by Patient Global Impression of Severity (PGIS)
Timepoint [52] 0 0
Up to 10 Years
Secondary outcome [53] 0 0
Arm A vs Arm C: Change in Participant Belief in in Efficacy of Treatment as Measured by PGIS
Timepoint [53] 0 0
Up to 10 Years

Eligibility
Key inclusion criteria
* Diagnosis of follicular lymphoma (FL).
* Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
* Are willing and able to comply with procedures required in the protocol.
* Must have stage, II, III or IV disease.
* Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
* Has one or more target lesions:

* A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
* >=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm) on CT scan or MRI
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: [Arm B] at the discretion of the Investigator, and rituximab and lenalidomide (R2) [Arm C].
* Have laboratory values meeting the criteria in the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Had major surgery within 4 weeks prior to randomization.
* Have active cytomegalovirus (CMV) disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/05/2037
Actual
Sample size
Target
1080
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center /ID# 260431 - Melbourne
Recruitment hospital [2] 0 0
Westmead Hospital /ID# 261465 - Westmead
Recruitment hospital [3] 0 0
Townsville University Hospital /ID# 259323 - Douglas
Recruitment hospital [4] 0 0
Princess Alexandra Hospital /ID# 259329 - Woolloongabba
Recruitment hospital [5] 0 0
Peninsula Private Hospital /ID# 259325 - Frankston
Recruitment hospital [6] 0 0
Royal Perth Hospital /ID# 259319 - Perth
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Idaho
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Belgium
State/province [16] 0 0
Limburg
Country [17] 0 0
Croatia
State/province [17] 0 0
Grad Zagreb
Country [18] 0 0
Croatia
State/province [18] 0 0
Primorsko-goranska Zupanija
Country [19] 0 0
Croatia
State/province [19] 0 0
Splitsko-dalmatinska Zupanija
Country [20] 0 0
Croatia
State/province [20] 0 0
Zadar
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 17
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha
Country [23] 0 0
France
State/province [23] 0 0
Haute-Corse
Country [24] 0 0
France
State/province [24] 0 0
Loire-Atlantique
Country [25] 0 0
France
State/province [25] 0 0
Rhone
Country [26] 0 0
France
State/province [26] 0 0
Sarthe
Country [27] 0 0
France
State/province [27] 0 0
Caen
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
Germany
State/province [29] 0 0
Baden-Wuerttemberg
Country [30] 0 0
Germany
State/province [30] 0 0
Hessen
Country [31] 0 0
Germany
State/province [31] 0 0
Rheinland-Pfalz
Country [32] 0 0
Germany
State/province [32] 0 0
Magdeburg
Country [33] 0 0
Hungary
State/province [33] 0 0
Vas
Country [34] 0 0
Israel
State/province [34] 0 0
H_efa
Country [35] 0 0
Israel
State/province [35] 0 0
HaDarom
Country [36] 0 0
Israel
State/province [36] 0 0
HaMerkaz
Country [37] 0 0
Israel
State/province [37] 0 0
Tel-Aviv
Country [38] 0 0
Israel
State/province [38] 0 0
Yerushalayim
Country [39] 0 0
Italy
State/province [39] 0 0
Torino
Country [40] 0 0
Italy
State/province [40] 0 0
Palermo
Country [41] 0 0
Japan
State/province [41] 0 0
Fukuoka
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Gyeonggido
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul Teugbyeolsi
Country [44] 0 0
Netherlands
State/province [44] 0 0
Noord-Brabant
Country [45] 0 0
Netherlands
State/province [45] 0 0
Zuid-Holland
Country [46] 0 0
Netherlands
State/province [46] 0 0
Groningen
Country [47] 0 0
New Zealand
State/province [47] 0 0
Auckland
Country [48] 0 0
Poland
State/province [48] 0 0
Malopolskie
Country [49] 0 0
Poland
State/province [49] 0 0
Mazowieckie
Country [50] 0 0
Portugal
State/province [50] 0 0
Lisboa
Country [51] 0 0
Portugal
State/province [51] 0 0
Porto
Country [52] 0 0
Portugal
State/province [52] 0 0
Regiao Autonoma Da Madeira
Country [53] 0 0
Puerto Rico
State/province [53] 0 0
Rio Piedras
Country [54] 0 0
Puerto Rico
State/province [54] 0 0
San Juan
Country [55] 0 0
Romania
State/province [55] 0 0
Bucuresti
Country [56] 0 0
Romania
State/province [56] 0 0
Iasi
Country [57] 0 0
Romania
State/province [57] 0 0
Olt
Country [58] 0 0
Romania
State/province [58] 0 0
Bucharest
Country [59] 0 0
Serbia
State/province [59] 0 0
Beograd
Country [60] 0 0
Serbia
State/province [60] 0 0
Pomoravski Okrug
Country [61] 0 0
Serbia
State/province [61] 0 0
Vojvodina
Country [62] 0 0
Serbia
State/province [62] 0 0
Novi Sad
Country [63] 0 0
Spain
State/province [63] 0 0
Cantabria
Country [64] 0 0
Spain
State/province [64] 0 0
Navarra
Country [65] 0 0
Spain
State/province [65] 0 0
Barcelona
Country [66] 0 0
Spain
State/province [66] 0 0
Caceres
Country [67] 0 0
Spain
State/province [67] 0 0
Madrid
Country [68] 0 0
Spain
State/province [68] 0 0
Salamanca
Country [69] 0 0
Taiwan
State/province [69] 0 0
Keelung
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genmab
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06191744