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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06230224




Registration number
NCT06230224
Ethics application status
Date submitted
29/12/2023
Date registered
30/01/2024

Titles & IDs
Public title
A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma
Scientific title
A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)
Secondary ID [1] 0 0
2022-502783-21-00
Secondary ID [2] 0 0
R1979-HM-2299
Universal Trial Number (UTN)
Trial acronym
OLYMPIA-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-Cell Non-Hodgkin Lymphoma (B-NHL) 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
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Odronextamab
Treatment: Drugs - Ifosfamide
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Rituximab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Cisplatin
Treatment: Drugs - Cytarabine
Treatment: Drugs - Gemcitabine

Experimental: Odronextamab - Participants will receive odronextamab monotherapy.

Active comparator: Standard Of Care - Participants will receive salvage therapy (ifosfamide, carboplatin, etoposide ± rituximab \[ICE ± R\], or dexamethasone, cisplatin, cytarabine ± rituximab \[DHAP ± R\], or gemcitabine, dexamethasone, cisplatin ± rituximab \[GDP ± R\]) and continue with autologous stem cell transplant (ASCT) following a complete response (CR)/partial response (PR).


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

Treatment: Drugs: Ifosfamide
Administered by IV infusion, as part of the ICE ± R salvage therapy

Treatment: Drugs: Carboplatin
Administered by IV infusion, as part of the ICE ± R salvage therapy

Treatment: Drugs: Etoposide
Administered by IV infusion, as part of the ICE ± R salvage therapy

Treatment: Drugs: Rituximab
Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.

Treatment: Drugs: Dexamethasone
Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.

Treatment: Drugs: Cisplatin
Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.

Treatment: Drugs: Cytarabine
Administered by IV infusion, as part of the DHAP ± R salvage therapy.

Treatment: Drugs: Gemcitabine
Administered by IV infusion, as part of the GDP ± R salvage therapy.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free survival (EFS) as assessed by independent central review
Timepoint [1] 0 0
Assessed up to 3 years
Secondary outcome [1] 0 0
Progression free survival (PFS) as assessed by independent central review
Timepoint [1] 0 0
Assessed up to 3 years
Secondary outcome [2] 0 0
Best overall response (BOR) as assessed by independent central review
Timepoint [2] 0 0
Assessed up to 6 months
Secondary outcome [3] 0 0
Overall change in physical functioning as measured by scores of the physical function scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30)
Timepoint [3] 0 0
Assessed up to 3 years
Secondary outcome [4] 0 0
EFS as assessed by local investigator
Timepoint [4] 0 0
Assessed up to 3 years
Secondary outcome [5] 0 0
PFS as assessed by local investigator
Timepoint [5] 0 0
Assessed up to 3 years
Secondary outcome [6] 0 0
BOR as assessed by local investigator
Timepoint [6] 0 0
Assessed up to 6 months
Secondary outcome [7] 0 0
Complete response (CR) as assessed by independent central review
Timepoint [7] 0 0
Assessed up to 6 months
Secondary outcome [8] 0 0
CR as assessed by local investigator
Timepoint [8] 0 0
Assessed up to 6 months
Secondary outcome [9] 0 0
Duration of response (DOR) assessed by independent central review
Timepoint [9] 0 0
Assessed up to 3 years
Secondary outcome [10] 0 0
DOR assessed by local investigator
Timepoint [10] 0 0
Assessed up to 3 years
Secondary outcome [11] 0 0
Overall survival (OS)
Timepoint [11] 0 0
Assessed up to 3 years
Secondary outcome [12] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [12] 0 0
Assessed up to 1 year
Secondary outcome [13] 0 0
Severity of TEAEs
Timepoint [13] 0 0
Assessed up to 1 year
Secondary outcome [14] 0 0
Odronextamab concentrations in serum
Timepoint [14] 0 0
Assessed up to 6 months
Secondary outcome [15] 0 0
Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration
Timepoint [15] 0 0
Assessed up to 6 months
Secondary outcome [16] 0 0
Titers of ADAs to odronextamab over the study duration
Timepoint [16] 0 0
Assessed up to 6 months
Secondary outcome [17] 0 0
Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration
Timepoint [17] 0 0
Assessed up to 6 months
Secondary outcome [18] 0 0
Measurable residual disease (MRD) status
Timepoint [18] 0 0
Assessed up to 6 months
Secondary outcome [19] 0 0
Duration of MRD-negativity, as determined by circulating tumor DNA (ctDNA)
Timepoint [19] 0 0
Assessed up to 3 years
Secondary outcome [20] 0 0
Overall change in patient-reported outcomes, as measured by scores of the EORTCQLQ- C30
Timepoint [20] 0 0
Assessed up to 3 years
Secondary outcome [21] 0 0
Overall change in patient-reported outcomes, as measured by scores of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)
Timepoint [21] 0 0
Assessed up to 3 years
Secondary outcome [22] 0 0
Overall change in patient-reported outcomes, as measured by scores of the EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)
Timepoint [22] 0 0
Assessed up to 3 years
Secondary outcome [23] 0 0
Overall change in score of the Global Population item 5 (GP5) of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire
Timepoint [23] 0 0
Assessed up to 3 years

Eligibility
Key inclusion criteria
Key

1. Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
2. Have primary refractory or relapse 12 months or less (=) from initiation of frontline therapy Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment
3. Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
4. Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
6. Adequate hematologic and organ function.

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 by non-primary CNS NHL, as described in the protocol
2. History of or current relevant CNS pathology, as described in the protocol
3. 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, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated
4. 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
5. Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
6. Allergy/hypersensitivity to study drug, or excipients.

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
15/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/05/2027
Actual
Sample size
Target
216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Olivia Newton John Cancer Wellness & Research Centre - Heidelberg
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
VIC 3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Forli Cesena
Country [2] 0 0
Italy
State/province [2] 0 0
Province Of Pordenone
Country [3] 0 0
Italy
State/province [3] 0 0
Brescia
Country [4] 0 0
Italy
State/province [4] 0 0
Novara
Country [5] 0 0
Italy
State/province [5] 0 0
Varese
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Gyeonggi-do
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Namdong-Gu
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul Teugbyeolsi
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Busan
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Daegu
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Ulsan
Country [13] 0 0
Malaysia
State/province [13] 0 0
Johor
Country [14] 0 0
Malaysia
State/province [14] 0 0
Sabah
Country [15] 0 0
Malaysia
State/province [15] 0 0
Selangor
Country [16] 0 0
Malaysia
State/province [16] 0 0
Wilayah Persekutuan Kuala Lumpur
Country [17] 0 0
Netherlands
State/province [17] 0 0
Rotterdam
Country [18] 0 0
Singapore
State/province [18] 0 0
Singapore
Country [19] 0 0
Spain
State/province [19] 0 0
Balearic Islands
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Navarra
Country [23] 0 0
Spain
State/province [23] 0 0
Granada
Country [24] 0 0
Spain
State/province [24] 0 0
Pamplona
Country [25] 0 0
Spain
State/province [25] 0 0
Sevilla
Country [26] 0 0
Spain
State/province [26] 0 0
Valencia
Country [27] 0 0
Taiwan
State/province [27] 0 0
Chianan Plain
Country [28] 0 0
Taiwan
State/province [28] 0 0
Changhua City
Country [29] 0 0
Taiwan
State/province [29] 0 0
Kaohsiung City
Country [30] 0 0
Taiwan
State/province [30] 0 0
Kaohsiung
Country [31] 0 0
Taiwan
State/province [31] 0 0
New Taipei City
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taichung
Country [33] 0 0
Taiwan
State/province [33] 0 0
Tainan
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taipei City
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taoyuan
Country [36] 0 0
Thailand
State/province [36] 0 0
Bangkok
Country [37] 0 0
Thailand
State/province [37] 0 0
Chiang Mai
Country [38] 0 0
Thailand
State/province [38] 0 0
Khon Kaen
Country [39] 0 0
Turkey
State/province [39] 0 0
Central Anatolia
Country [40] 0 0
Turkey
State/province [40] 0 0
Mersin
Country [41] 0 0
Turkey
State/province [41] 0 0
Suleymanpasa
Country [42] 0 0
Turkey
State/province [42] 0 0
Ankara
Country [43] 0 0
Turkey
State/province [43] 0 0
Izmir
Country [44] 0 0
Turkey
State/province [44] 0 0
Sakarya
Country [45] 0 0
Turkey
State/province [45] 0 0
Samsun

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/NCT06230224