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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06149286




Registration number
NCT06149286
Ethics application status
Date submitted
20/11/2023
Date registered
28/11/2023

Titles & IDs
Public title
A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone 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, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide Therapy in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)
Secondary ID [1] 0 0
2022-503092-28-00
Secondary ID [2] 0 0
R1979-ONC-22102
Universal Trial Number (UTN)
Trial acronym
OLYMPIA-5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Follicular Lymphoma 0 0
Marginal Zone Lymphoma (MZL) 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 - Lenalidomide
Treatment: Drugs - Rituximab

Experimental: Odronextamab+Lenalidomide - In part 1 (safety run-in), participants with R/R indolent lymphoma (FL and MZL), will receive odronextamab in combination with lenalidomide.

In part 2, 1:1 randomized participants with indolent lymphoma (FL/MZL), will receive odronextamab in combination with lenalidomide.

Experimental: Rituximab+Lenalidomide - In part 2 only, 1:1 randomized participants with R/R lymphoma (FL and ML), will receive rituximab in combination with lenalidomide (R2) followed by lenalidomide monotherapy.


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

Treatment: Drugs: Lenalidomide
Administered orally (PO)

Treatment: Drugs: Rituximab
Administered by IV infusion, or subcutaneously (SC)
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 in combination with lenalidomide
Timepoint [1] 0 0
Up to 35 days
Primary outcome [2] 0 0
Incidence of treatment emergent adverse events (TEAEs) for odronextamab in combination with lenalidomide
Timepoint [2] 0 0
Up to 2 years
Primary outcome [3] 0 0
Severity of TEAEs for odronextamab in combination with lenalidomide
Timepoint [3] 0 0
Up to 2 years
Primary outcome [4] 0 0
Progression-free survival (PFS) as assessed by independent central review (ICR) in participants with R/R FL and participants with indolent lymphoma
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Odronextamab concentrations in serum
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Incidence of anti-drug antibodies (ADA) 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
Best overall response (BOR) as assessed by investigator review
Timepoint [5] 0 0
Up to 30 months
Secondary outcome [6] 0 0
Duration of response (DOR) as assessed by investigator review
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
PFS as assessed by investigator review
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Complete response (CR) as assessed by ICR
Timepoint [8] 0 0
Up to 30 months
Secondary outcome [9] 0 0
BOR as assessed by ICR
Timepoint [9] 0 0
Up to 30 months
Secondary outcome [10] 0 0
Overall survival (OS)
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Event free survival (EFS) as assessed by ICR
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
EFS as assessed by local investigator review
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
DOR as assessed by ICR
Timepoint [13] 0 0
Up to 5 years
Secondary outcome [14] 0 0
Time to next anti-lymphoma treatment (TTNT)
Timepoint [14] 0 0
Up to 5 years
Secondary outcome [15] 0 0
Incidence of TEAEs for odronextamab in combination with lenalidomide versus R2
Timepoint [15] 0 0
Up to 2 years
Secondary outcome [16] 0 0
Severity of TEAEs for odronextamab in combination with lenalidomide versus R2
Timepoint [16] 0 0
Up to 2 years
Secondary outcome [17] 0 0
Overall change in patient reported outcomes (PROs) as measured by scores of European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQC30)
Timepoint [17] 0 0
Up to 5 years
Secondary outcome [18] 0 0
Overall change in PROs as measured by scores of Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)
Timepoint [18] 0 0
Up to 5 years
Secondary outcome [19] 0 0
Overall change in PROs as measured by scores of Patient Global Impression on Severity (PGIS)
Timepoint [19] 0 0
Up to 5 years
Secondary outcome [20] 0 0
Overall change in PROs as measured by scores of Patient Global Impression on Change (PGIC)
Timepoint [20] 0 0
Up to 5 years
Secondary outcome [21] 0 0
Overall change in PROs as measured by scores of EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L)
Timepoint [21] 0 0
Up to 5 years
Secondary outcome [22] 0 0
Overall change in score of the global population item 5 (GP5) items of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire
Timepoint [22] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
Key

1. Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.
2. Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody and participant should meet indication for treatment, as described in the protocol.
3. Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Adequate hematologic and organ function, as described in the protocol.
6. All study participants must:

1. Have an understanding that lenalidomide could have a potential teratogenic risk.
2. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide.
3. Agree not to share study medication with another person.
4. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL, as described in the protocol.
2. Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.
3. History of or current relevant CNS pathology, as described in the protocol.
4. A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated.
5. Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.
6. Allergy/hypersensitivity to study drugs or excipients. as described in the protocol.
7. Active infection as defined in the protocol.

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
28/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/01/2029
Actual
Sample size
Target
470
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [3] 0 0
Epworth Freemasons Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
3121 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Wisconsin
Country [5] 0 0
Austria
State/province [5] 0 0
Upper Austria
Country [6] 0 0
Austria
State/province [6] 0 0
Wels
Country [7] 0 0
Belgium
State/province [7] 0 0
Oost-Vlaanderen
Country [8] 0 0
Belgium
State/province [8] 0 0
West Flanders
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussels
Country [10] 0 0
Belgium
State/province [10] 0 0
Yvoir
Country [11] 0 0
Czechia
State/province [11] 0 0
Hradec Kralove 5
Country [12] 0 0
Czechia
State/province [12] 0 0
Prague
Country [13] 0 0
Czechia
State/province [13] 0 0
Praha
Country [14] 0 0
France
State/province [14] 0 0
Cedex 10
Country [15] 0 0
France
State/province [15] 0 0
Centre-Val De Loire
Country [16] 0 0
France
State/province [16] 0 0
Gironde
Country [17] 0 0
France
State/province [17] 0 0
Ile De France
Country [18] 0 0
France
State/province [18] 0 0
Nord
Country [19] 0 0
France
State/province [19] 0 0
Normandie
Country [20] 0 0
France
State/province [20] 0 0
Savoie
Country [21] 0 0
France
State/province [21] 0 0
Nantes
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Rennes
Country [24] 0 0
France
State/province [24] 0 0
Île De France
Country [25] 0 0
France
State/province [25] 0 0
Île-de-France
Country [26] 0 0
Italy
State/province [26] 0 0
Forli-Cesena
Country [27] 0 0
Italy
State/province [27] 0 0
Monza E Brianza
Country [28] 0 0
Italy
State/province [28] 0 0
Province Of Pordenone
Country [29] 0 0
Italy
State/province [29] 0 0
Torino
Country [30] 0 0
Italy
State/province [30] 0 0
Bologna
Country [31] 0 0
Italy
State/province [31] 0 0
Brescia
Country [32] 0 0
Italy
State/province [32] 0 0
Genova
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Napoli
Country [35] 0 0
Italy
State/province [35] 0 0
Novara
Country [36] 0 0
Italy
State/province [36] 0 0
Ravenna
Country [37] 0 0
Italy
State/province [37] 0 0
Udine
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Gyeonggi-do
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Seoul Teugbyeolsi
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Busan
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Daegu
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Suwon
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Ulsan
Country [45] 0 0
Malaysia
State/province [45] 0 0
Johor
Country [46] 0 0
Malaysia
State/province [46] 0 0
Negeri/Wilayah Persekutuan
Country [47] 0 0
Malaysia
State/province [47] 0 0
Sabah
Country [48] 0 0
Malaysia
State/province [48] 0 0
Selangor
Country [49] 0 0
Poland
State/province [49] 0 0
Malopolska
Country [50] 0 0
Poland
State/province [50] 0 0
Wielkopolska
Country [51] 0 0
Poland
State/province [51] 0 0
Katowice
Country [52] 0 0
Spain
State/province [52] 0 0
A Coruña
Country [53] 0 0
Spain
State/province [53] 0 0
Balearic Islands
Country [54] 0 0
Spain
State/province [54] 0 0
Cantabria
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Granada
Country [58] 0 0
Spain
State/province [58] 0 0
Salamanca
Country [59] 0 0
Spain
State/province [59] 0 0
Seville
Country [60] 0 0
Spain
State/province [60] 0 0
Valencia
Country [61] 0 0
Taiwan
State/province [61] 0 0
Changhua city
Country [62] 0 0
Taiwan
State/province [62] 0 0
Chiayi City
Country [63] 0 0
Taiwan
State/province [63] 0 0
New Taipei City
Country [64] 0 0
Taiwan
State/province [64] 0 0
Tainan City
Country [65] 0 0
Taiwan
State/province [65] 0 0
Taipei City
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taipei
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taoyuan City
Country [68] 0 0
Thailand
State/province [68] 0 0
Krung Thep Maha Nakhon [Bangko]
Country [69] 0 0
Thailand
State/province [69] 0 0
Bangkok
Country [70] 0 0
Thailand
State/province [70] 0 0
Chiang Mai
Country [71] 0 0
Turkey
State/province [71] 0 0
Ankara
Country [72] 0 0
Turkey
State/province [72] 0 0
Suleymanpasa
Country [73] 0 0
Turkey
State/province [73] 0 0
Izmir
Country [74] 0 0
Turkey
State/province [74] 0 0
Sakarya
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Cornwall
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Devon
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Dorset
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Essex
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Middx

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
[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?
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/NCT06149286