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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06097364




Registration number
NCT06097364
Ethics application status
Date submitted
18/10/2023
Date registered
24/10/2023

Titles & IDs
Public title
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
Scientific title
A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)
Secondary ID [1] 0 0
2022-502113-28-00
Secondary ID [2] 0 0
R1979-ONC-2075
Universal Trial Number (UTN)
Trial acronym
OLYMPIA-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 - Odronextamab
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone/Prenisolone

Experimental: Odronextamab + Chemotherapy - Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.

Active comparator: Rituximab + Chemotherapy - In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.

Experimental: Odronextamab + Chemotherapy + Maintenance - In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy \[CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)\], followed by odronextamab monotherapy maintenance.

Experimental: Odronextamab + Chemotherapy + No maintenance - In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.


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

Treatment: Drugs: Rituximab
Administered by IV infusion, or subcutaneous (SC)

Treatment: Drugs: Cyclophosphamide
Administered by IV infusion

Treatment: Drugs: Doxorubicin
Administered by IV infusion

Treatment: Drugs: Vincristine
Administered by IV infusion

Treatment: Drugs: Prednisone/Prenisolone
Administered orally (PO)
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 chemotherapy
Timepoint [1] 0 0
Up to 35 days
Primary outcome [2] 0 0
Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy
Timepoint [2] 0 0
Up to 2 years
Primary outcome [3] 0 0
Severity of TEAEs of odronextamab in combination with chemotherapy
Timepoint [3] 0 0
Up to 2 years
Primary outcome [4] 0 0
Complete Response rate at 30 months (CR30) assessed by independent central review (ICR)
Timepoint [4] 0 0
Up to 30 months
Secondary outcome [1] 0 0
Odronextamab concentrations in serum when administered with chemotherapy
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Odronextamab concentrations in serum when administered as monotherapy
Timepoint [2] 0 0
Up to 30 months
Secondary outcome [3] 0 0
Incidence of anti-odronextamab antibodies (ADAs)
Timepoint [3] 0 0
Up to 30 months
Secondary outcome [4] 0 0
Titers of ADAs to odronextamab
Timepoint [4] 0 0
Up to 30 months
Secondary outcome [5] 0 0
Incidence of neutralizing antibodies (NAb) to odronextamab
Timepoint [5] 0 0
Up to 30 months
Secondary outcome [6] 0 0
Best overall response (BOR) as assessed by the investigator
Timepoint [6] 0 0
Up to 30 months
Secondary outcome [7] 0 0
Progression free survival (PFS) as assessed by ICR
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
Change in patient reported physical functioning scale scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
PFS as assessed by local investigator
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
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
Overall Survival (OS)
Timepoint [13] 0 0
Up to 5 years
Secondary outcome [14] 0 0
BOR as assessed by local investigator
Timepoint [14] 0 0
Up to 30 months
Secondary outcome [15] 0 0
BOR as assessed by ICR
Timepoint [15] 0 0
Up to 30 months
Secondary outcome [16] 0 0
Duration of response (DOR) assessed by ICR
Timepoint [16] 0 0
Up to 5 years
Secondary outcome [17] 0 0
DOR as assessed by local investigator
Timepoint [17] 0 0
Up to 5 years
Secondary outcome [18] 0 0
Time to next anti-lymphoma treatment (TTNT)
Timepoint [18] 0 0
Up to 5 years
Secondary outcome [19] 0 0
Incidence of TEAEs
Timepoint [19] 0 0
Up to 2 years
Secondary outcome [20] 0 0
Severity of TEAEs
Timepoint [20] 0 0
Up to 2 years
Secondary outcome [21] 0 0
Change in patient reported health related quality of life (HRQoL) as measured by EORTC-QLQ-C30
Timepoint [21] 0 0
Up to 5 years
Secondary outcome [22] 0 0
Change in cancer disease as measured by EORTC-QLQ-C30
Timepoint [22] 0 0
Up to 5 years
Secondary outcome [23] 0 0
Change in treatment related symptoms as measured by EORTC-QLQ-C30
Timepoint [23] 0 0
Up to 5 years
Secondary outcome [24] 0 0
Change in patient-reported lymphoma disease as measured by the Lymphoma Subscale of the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS)
Timepoint [24] 0 0
Up to 5 years
Secondary outcome [25] 0 0
Change in treatment-related symptoms as measured by the FACT-LymS
Timepoint [25] 0 0
Up to 5 years
Secondary outcome [26] 0 0
Change in patient-reported general health status per EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Timepoint [26] 0 0
Up to 5 years
Secondary outcome [27] 0 0
Change in patient-reported treatment side effects burden per Functional Assessment of Cancer Therapy-General Global Population Item 5 (FACT-G GP5)
Timepoint [27] 0 0
Up to 5 years
Secondary outcome [28] 0 0
Change in Patient Global Impression of Severity (PGIS)
Timepoint [28] 0 0
Up to 5 years
Secondary outcome [29] 0 0
Change in Patient Global Impression of Change (PGIC)
Timepoint [29] 0 0
Up to 5 years
Secondary outcome [30] 0 0
Change in score of the FACT-G GP5 item in the patient population
Timepoint [30] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
Key

1. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV

1. For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
2. Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Adequate bone marrow 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. Participants with central nervous system lymphoma or leptomeningeal lymphoma
2. Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
4. Recent major surgery and history or organ transplantation
5. A malignancy other than NHL unless the participant is adequately and definitively treated and 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.

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
14/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/07/2029
Actual
Sample size
Target
733
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Pindara Private Hospital - Benowa
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Belgium
State/province [8] 0 0
Oost Vlaanderen
Country [9] 0 0
Belgium
State/province [9] 0 0
Oost-Vlaanderen
Country [10] 0 0
Belgium
State/province [10] 0 0
West Flanders
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Liege
Country [13] 0 0
Chile
State/province [13] 0 0
Las Condes
Country [14] 0 0
Chile
State/province [14] 0 0
Region Metropolitana
Country [15] 0 0
Israel
State/province [15] 0 0
Jerusalem
Country [16] 0 0
Israel
State/province [16] 0 0
Petah Tikva
Country [17] 0 0
Israel
State/province [17] 0 0
Tel Aviv
Country [18] 0 0
Italy
State/province [18] 0 0
Emilia-Romagna
Country [19] 0 0
Italy
State/province [19] 0 0
Forli Cesena
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Modena
Country [22] 0 0
Italy
State/province [22] 0 0
Napoli
Country [23] 0 0
Italy
State/province [23] 0 0
Perugia
Country [24] 0 0
Italy
State/province [24] 0 0
Ravenna
Country [25] 0 0
Italy
State/province [25] 0 0
Reggio Emilia
Country [26] 0 0
Italy
State/province [26] 0 0
Udine
Country [27] 0 0
Poland
State/province [27] 0 0
Malopolskie
Country [28] 0 0
Poland
State/province [28] 0 0
Bydgoszcz
Country [29] 0 0
Poland
State/province [29] 0 0
Gdansk
Country [30] 0 0
Poland
State/province [30] 0 0
Katowice
Country [31] 0 0
Poland
State/province [31] 0 0
Walbrzych
Country [32] 0 0
Spain
State/province [32] 0 0
Asturas
Country [33] 0 0
Spain
State/province [33] 0 0
Asturias
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Pamplona
Country [37] 0 0
Spain
State/province [37] 0 0
Salamanca
Country [38] 0 0
Spain
State/province [38] 0 0
Sevilla
Country [39] 0 0
Spain
State/province [39] 0 0
Toledo
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Taiwan
State/province [41] 0 0
Kaohsiung City
Country [42] 0 0
Taiwan
State/province [42] 0 0
Kaohsiung
Country [43] 0 0
Taiwan
State/province [43] 0 0
New Taipei City
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei City
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taipei
Country [46] 0 0
Thailand
State/province [46] 0 0
Krung Thep Maha Nakhon [Bangko]
Country [47] 0 0
Thailand
State/province [47] 0 0
Khon Kaen
Country [48] 0 0
Turkey
State/province [48] 0 0
Ankara
Country [49] 0 0
Turkey
State/province [49] 0 0
Central Anatolia
Country [50] 0 0
Turkey
State/province [50] 0 0
Serdivan
Country [51] 0 0
Turkey
State/province [51] 0 0
Suleymanpasa
Country [52] 0 0
Turkey
State/province [52] 0 0
Istanbul
Country [53] 0 0
Turkey
State/province [53] 0 0
Kayseri
Country [54] 0 0
Turkey
State/province [54] 0 0
Samsun
Country [55] 0 0
Turkey
State/province [55] 0 0
Zonguldak
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Cornwall
Country [57] 0 0
United Kingdom
State/province [57] 0 0
West Midlands
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Aberdeen

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, has made the study 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/NCT06097364