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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06091254




Registration number
NCT06091254
Ethics application status
Date submitted
13/10/2023
Date registered
19/10/2023

Titles & IDs
Public title
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma
Scientific title
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
Secondary ID [1] 0 0
2022-502660-20-00
Secondary ID [2] 0 0
R1979-HM-2298
Universal Trial Number (UTN)
Trial acronym
OLYMPIA-1
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 - Odronextamab
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone/prednisolone
Treatment: Drugs - Bendamustine

Experimental: Odronextamab - Part 1 is a safety run-in. All participants will receive odronextamab.

In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.

Active comparator: Rituximab + Investigator's Choice Chemotherapy - Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.


Treatment: Drugs: Odronextamab
Administered by intravenous infusion (IV)

Treatment: Drugs: Rituximab
Rituximab will be administered by IV, or subcutaneously (SC)

Treatment: Drugs: Cyclophosphamide
Administered by IV as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy

Treatment: Drugs: Doxorubicin
Administered by IV as part of CHOP chemotherapy

Treatment: Drugs: Vincristine
Administered by IV as part of CHOP, and CVP chemotherapy

Treatment: Drugs: Prednisone/prednisolone
Administered orally (PO) as part of CVP chemotherapy

Treatment: Drugs: Bendamustine
Administered by IV as part of chemotherapy (Rituximab-Bendamustine)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities (DLTs) for odronextamab
Timepoint [1] 0 0
Up to 35 days
Primary outcome [2] 0 0
Incidence of treatment-emergent adverse events (TEAEs) of odronextamab
Timepoint [2] 0 0
Up to 2 years
Primary outcome [3] 0 0
Severity of TEAEs of odronextamab
Timepoint [3] 0 0
Up to 2 years
Primary outcome [4] 0 0
Complete Response at 30 months (CR30) as assessed by independent central review
Timepoint [4] 0 0
Up to 30 months
Secondary outcome [1] 0 0
Concentrations of odronextamab in serum
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration
Timepoint [2] 0 0
Up to 30 months
Secondary outcome [3] 0 0
Titer of ADAs to odronextamab over the study duration
Timepoint [3] 0 0
Up to 30 months
Secondary outcome [4] 0 0
Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration
Timepoint [4] 0 0
Up to 30 months
Secondary outcome [5] 0 0
Objective response as assessed by the investigator
Timepoint [5] 0 0
Up to 30 months
Secondary outcome [6] 0 0
Progression-free survival (PFS) as assessed by independent central review
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Event-free survival (EFS) as assessed by independent central review
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
CR30 as assessed by local investigator
Timepoint [8] 0 0
Up to 30 months
Secondary outcome [9] 0 0
Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)]
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Overall survival (OS)
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
PFS as assessed by the local investigator
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
EFS as assessed by the local investigator
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
Objective response assessed by local investigator
Timepoint [13] 0 0
Up to 30 months
Secondary outcome [14] 0 0
Objective response assessed by independent central review
Timepoint [14] 0 0
Up to 30 months
Secondary outcome [15] 0 0
Duration of response (DOR) assessed by independent central review
Timepoint [15] 0 0
Up to 5 years
Secondary outcome [16] 0 0
DOR assessed by local investigator
Timepoint [16] 0 0
Up to 5 years
Secondary outcome [17] 0 0
Time to next anti-lymphoma treatment (TTNT)
Timepoint [17] 0 0
Up to 5 years
Secondary outcome [18] 0 0
Incidence of TEAEs
Timepoint [18] 0 0
Up to 2 years
Secondary outcome [19] 0 0
Severity of TEAEs
Timepoint [19] 0 0
Up to 2 years
Secondary outcome [20] 0 0
Odronextamab concentrations in serum during the induction period
Timepoint [20] 0 0
Up to 30 months
Secondary outcome [21] 0 0
Odronextamab concentrations in serum during the maintenance period
Timepoint [21] 0 0
Up to 30 months
Secondary outcome [22] 0 0
Incidence of ADAs to odronextamab over the study duration
Timepoint [22] 0 0
Up to 30 months
Secondary outcome [23] 0 0
Titer of ADAs to odronextamab over the study duration
Timepoint [23] 0 0
Up to 30 months
Secondary outcome [24] 0 0
Incidence of NAbs to odronextamab over the study duration
Timepoint [24] 0 0
Up to 30 months
Secondary outcome [25] 0 0
Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30
Timepoint [25] 0 0
Up to 5 years
Secondary outcome [26] 0 0
Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)
Timepoint [26] 0 0
Up to 5 years
Secondary outcome [27] 0 0
Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Severity (PGIS)
Timepoint [27] 0 0
Up to 5 years
Secondary outcome [28] 0 0
Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Change (PGIC)
Timepoint [28] 0 0
Up to 5 years
Secondary outcome [29] 0 0
Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)
Timepoint [29] 0 0
Up to 5 years
Secondary outcome [30] 0 0
Overall mean changes in scores PROs, as measured by the validated Functional Assessment of Cancer - General (FACT-G) global population 5 (GP5) question
Timepoint [30] 0 0
Up to 5 years
Secondary outcome [31] 0 0
Change in score of the GP5 item in the participant population
Timepoint [31] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
Key

1. Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
2. Need for treatment as described in the protocol
3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5. Adequate bone marrow function and hepatic function

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
4. Treatment with any systemic anti-lymphoma therapy
5. Infections and allergy/hypersensitivity to study drug or excipient

NOTE: Other protocol defined inclusion/exclusion criteria apply

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
12/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/04/2029
Actual
Sample size
Target
478
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Ingham Institute - Liverpool
Recruitment hospital [2] 0 0
Icon Cancer Centre - Wesley - Auchenflower
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment hospital [5] 0 0
Epworth Freemasons - East Melbourne
Recruitment hospital [6] 0 0
St Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [7] 0 0
Alfred Hospital and Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3121 - East Melbourne
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Austria
State/province [12] 0 0
Osterreich
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Salzburg
Country [15] 0 0
Austria
State/province [15] 0 0
Vienna
Country [16] 0 0
Canada
State/province [16] 0 0
New Brunswick
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Chile
State/province [18] 0 0
Region Metropolitana
Country [19] 0 0
Czechia
State/province [19] 0 0
Hradec Kralove
Country [20] 0 0
Czechia
State/province [20] 0 0
Prague
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha
Country [22] 0 0
France
State/province [22] 0 0
Bretagne
Country [23] 0 0
France
State/province [23] 0 0
Centre Val De Loire
Country [24] 0 0
France
State/province [24] 0 0
Ile De France
Country [25] 0 0
France
State/province [25] 0 0
Pays De La Loire
Country [26] 0 0
France
State/province [26] 0 0
Provence-Alpes-Cote d'Azur
Country [27] 0 0
France
State/province [27] 0 0
Val De Marne / Ile De France
Country [28] 0 0
France
State/province [28] 0 0
Angers
Country [29] 0 0
France
State/province [29] 0 0
Marseille
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Poitiers
Country [32] 0 0
France
State/province [32] 0 0
Strasbourg
Country [33] 0 0
Germany
State/province [33] 0 0
Hesse
Country [34] 0 0
Germany
State/province [34] 0 0
Rheinland-Pfalz
Country [35] 0 0
Germany
State/province [35] 0 0
Sachsen
Country [36] 0 0
Germany
State/province [36] 0 0
Kiel
Country [37] 0 0
Israel
State/province [37] 0 0
Ashdod
Country [38] 0 0
Israel
State/province [38] 0 0
Haifa
Country [39] 0 0
Israel
State/province [39] 0 0
Jerusalem
Country [40] 0 0
Israel
State/province [40] 0 0
Nahariya
Country [41] 0 0
Israel
State/province [41] 0 0
Petah-Tikva
Country [42] 0 0
Israel
State/province [42] 0 0
Ramat-Gan
Country [43] 0 0
Israel
State/province [43] 0 0
Tel Aviv
Country [44] 0 0
Italy
State/province [44] 0 0
Forli Cesena
Country [45] 0 0
Italy
State/province [45] 0 0
Italia
Country [46] 0 0
Italy
State/province [46] 0 0
Liguria
Country [47] 0 0
Italy
State/province [47] 0 0
Torino
Country [48] 0 0
Italy
State/province [48] 0 0
Ascoli Piceno
Country [49] 0 0
Italy
State/province [49] 0 0
Brescia
Country [50] 0 0
Italy
State/province [50] 0 0
Milano
Country [51] 0 0
Italy
State/province [51] 0 0
Napoli
Country [52] 0 0
Italy
State/province [52] 0 0
Novara
Country [53] 0 0
Italy
State/province [53] 0 0
Ravenna
Country [54] 0 0
Italy
State/province [54] 0 0
Udine
Country [55] 0 0
Italy
State/province [55] 0 0
Varese
Country [56] 0 0
Poland
State/province [56] 0 0
Dolnoslaskie
Country [57] 0 0
Poland
State/province [57] 0 0
Lower Silesian
Country [58] 0 0
Poland
State/province [58] 0 0
Malopolska
Country [59] 0 0
Poland
State/province [59] 0 0
Pomorskie
Country [60] 0 0
Poland
State/province [60] 0 0
Wielkopolska
Country [61] 0 0
Poland
State/province [61] 0 0
Katowice
Country [62] 0 0
Spain
State/province [62] 0 0
A Coruna
Country [63] 0 0
Spain
State/province [63] 0 0
Andalucia
Country [64] 0 0
Spain
State/province [64] 0 0
Asturias
Country [65] 0 0
Spain
State/province [65] 0 0
Balearic Islands
Country [66] 0 0
Spain
State/province [66] 0 0
Bizkaia
Country [67] 0 0
Spain
State/province [67] 0 0
Cantabria
Country [68] 0 0
Spain
State/province [68] 0 0
Galicia
Country [69] 0 0
Spain
State/province [69] 0 0
Madrid
Country [70] 0 0
Spain
State/province [70] 0 0
Navarra
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona
Country [72] 0 0
Spain
State/province [72] 0 0
Granada
Country [73] 0 0
Spain
State/province [73] 0 0
Murcia
Country [74] 0 0
Spain
State/province [74] 0 0
Salamanca
Country [75] 0 0
Spain
State/province [75] 0 0
Sevilla
Country [76] 0 0
Spain
State/province [76] 0 0
Seville
Country [77] 0 0
Spain
State/province [77] 0 0
Toledo
Country [78] 0 0
Spain
State/province [78] 0 0
Valencia
Country [79] 0 0
Switzerland
State/province [79] 0 0
Aargau
Country [80] 0 0
Switzerland
State/province [80] 0 0
Saint Gallen
Country [81] 0 0
Switzerland
State/province [81] 0 0
Schweiz
Country [82] 0 0
Switzerland
State/province [82] 0 0
Basel
Country [83] 0 0
Switzerland
State/province [83] 0 0
Bern
Country [84] 0 0
Taiwan
State/province [84] 0 0
Guishan District
Country [85] 0 0
Taiwan
State/province [85] 0 0
Changhua City
Country [86] 0 0
Taiwan
State/province [86] 0 0
Chiayi City
Country [87] 0 0
Taiwan
State/province [87] 0 0
Kaohsiung
Country [88] 0 0
Taiwan
State/province [88] 0 0
New Taipei City
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taichung
Country [90] 0 0
Taiwan
State/province [90] 0 0
Tainan
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taipei City
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taipei
Country [93] 0 0
Turkey
State/province [93] 0 0
Ankara
Country [94] 0 0
Turkey
State/province [94] 0 0
Central Anatolia
Country [95] 0 0
Turkey
State/province [95] 0 0
Mersin
Country [96] 0 0
Turkey
State/province [96] 0 0
Suleymanpasa
Country [97] 0 0
Turkey
State/province [97] 0 0
Istanbul
Country [98] 0 0
Turkey
State/province [98] 0 0
Izmir
Country [99] 0 0
Turkey
State/province [99] 0 0
Kayseri
Country [100] 0 0
Turkey
State/province [100] 0 0
Sakarya
Country [101] 0 0
Turkey
State/province [101] 0 0
Samsun
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Cornwall
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Devon
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Dorset
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Lanarkshire
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Norfolk
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Romford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
clinicaltrials@regeneron.com
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?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
When Regeneron has :

* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
* made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
* has the legal authority to share the data, and
* has ensured the ability to protect participant privacy
Available to whom?
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT06091254