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 (OLYMPIA-1)
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| ClinicalTrials.gov Identifier: NCT06091254 |
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Recruitment Status :
Recruiting
First Posted : October 19, 2023
Last Update Posted : May 1, 2024
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Sponsor:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
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Brief Summary:
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).
This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is. The aim of Part 2 of the study is to see how the study drug works compared to rituximab and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in your blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
- The impact from the study drug on your quality of life and ability to complete routine daily activities.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Follicular Lymphoma (FL) | Drug: Odronextamab Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone/prednisolone Drug: Bendamustine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 478 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official 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) |
| Actual Study Start Date : | December 12, 2023 |
| Estimated Primary Completion Date : | April 3, 2029 |
| Estimated Study Completion Date : | April 3, 2029 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information
available for:
Rituximab
| Arm | Intervention/treatment |
|---|---|
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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. |
Drug: Odronextamab
Administered by intravenous infusion (IV)
Other Name: REGN1979 |
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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.
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Drug: Rituximab
Rituximab will be administered by IV, or subcutaneously (SC)
Other Name: Rituxan Drug: Cyclophosphamide Administered by IV as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
Other Name: Cytoxan Drug: Doxorubicin Administered by IV as part of CHOP chemotherapy
Other Name: Adriamycin Drug: Vincristine Administered by IV as part of CHOP, and CVP chemotherapy
Other Name: Oncovin Drug: Prednisone/prednisolone Administered orally (PO) as part of CVP chemotherapy
Other Name: Deltasone/Omnipred Drug: Bendamustine Administered by IV as part of chemotherapy (Rituximab-Bendamustine)
Other Name: Treanda |
Primary Outcome Measures :
- Incidence of dose-limiting toxicities (DLTs) for odronextamab [ Time Frame: Up to 35 days ]Part 1
- Incidence of treatment-emergent adverse events (TEAEs) of odronextamab [ Time Frame: Up to 2 years ]Part 1
- Severity of TEAEs of odronextamab [ Time Frame: Up to 2 years ]Part 1
- Complete Response at 30 months (CR30) as assessed by independent central review [ Time Frame: Up to 30 months ]Part 2
Secondary Outcome Measures :
- Concentrations of odronextamab in serum [ Time Frame: Up to 30 months ]Part 1
- Incidence of anti-odronextamab antibodies (ADAs) [ Time Frame: Up to 30 months ]Part 1
- Titer of ADAs [ Time Frame: Up to 30 months ]Part 1
- Incidence of neutralizing antibodies (NAbs) to odronextamab [ Time Frame: Up to 30 months ]Part 1
- Objective response as assessed by the investigator [ Time Frame: Up to 30 months ]Part 1
- Progression-free survival (PFS) as assessed by independent central review [ Time Frame: Up to 5 years ]Part 2
- Event-free survival (EFS) as assessed by independent central review [ Time Frame: Up to 5 years ]Part 2
- CR30 as assessed by local investigator [ Time Frame: Up to 30 months ]Part 2
- Overall mean change from baseline in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)] [ Time Frame: Up to 5 years ]Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.
- Overall survival (OS) [ Time Frame: Up to 5 years ]Part 2
- PFS as assessed by the local investigator [ Time Frame: Up to 5 years ]Part 2
- EFS as assessed by the local investigator [ Time Frame: Up to 5 years ]Part 2
- Objective response assessed by local investigator [ Time Frame: Up to 30 months ]Part 2
- Objective response assessed by independent central review [ Time Frame: Up to 30 months ]Part 2
- Duration of response (DOR) assessed by independent central review [ Time Frame: Up to 5 years ]Part 2
- DOR assessed by local investigator [ Time Frame: Up to 5 years ]Part 2
- Time to next anti-lymphoma treatment (TTNT) [ Time Frame: Up to 5 years ]Part 2
- Incidence of TEAEs [ Time Frame: Up to 2 years ]Part 2
- Severity of TEAEs [ Time Frame: Up to 2 years ]Part 2
- Odronextamab concentrations in serum during the induction period [ Time Frame: Up to 30 months ]Part 2
- Odronextamab concentrations in serum during the maintenance period [ Time Frame: Up to 30 months ]Part 2
- Incidence of ADAs to odronextamab over time [ Time Frame: Up to 30 months ]Part 2
- Titer of ADAs to odronextamab over time [ Time Frame: Up to 30 months ]Part 2
- Incidence of NAbs to odronextamab over time [ Time Frame: Up to 30 months ]Part 2
- Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30 [ Time Frame: Up to 5 years ]Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.
- Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS) [ Time Frame: Up to 5 years ]Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.
- Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Severity (PGIS) [ Time Frame: Up to 5 years ]Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe).
- Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Change (PGIC) [ Time Frame: Up to 5 years ]Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse.
- Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L) [ Time Frame: Up to 5 years ]Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".
- Overall mean changes in scores PROs, as measured by the validated Functional Assessment of Cancer - General (FACT-G) global population 5 (GP5) question [ Time Frame: Up to 5 years ]Part 2 A single item Global Population item 5 (GP5) of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).
- Change in score of the GP5 item in the participant population [ Time Frame: Up to 5 years ]Part 2 A single item Global Population item 5 (GP5) of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Diagnosis of cluster of differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
- Need for treatment as described in the protocol
- Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed tomography (CT) or Magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow function and hepatic function
Key Exclusion Criteria:
- Central nervous system (CNS) lymphoma or leptomeningeal lymphoma
- Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
- Treatment with any systemic anti-lymphoma therapy
- Infections and allergy/hypersensitivity to study drug or excipient
NOTE: Other protocol defined inclusion / exclusion criteria apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06091254
Contacts
| Contact: Clinical Trials Administrator | 844-734-6643 | clinicaltrials@regeneron.com |
Locations
Show 66 study locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT06091254 |
| Other Study ID Numbers: |
R1979-HM-2298 2022-502660-20-00 ( Other Identifier: EUCT Number ) |
| First Posted: | October 19, 2023 Key Record Dates |
| Last Update Posted: | May 1, 2024 |
| Last Verified: | December 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | 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 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. |
| Access Criteria: | 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 |
| URL: | https://vivli.org/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Regeneron Pharmaceuticals:
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Non-Hodgkin lymphomas (NHLs) Indolent NHL B-cells NHL (B-NHL) Follicular lymphoma Odronextamab |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Prednisone Prednisolone Cyclophosphamide Bendamustine Hydrochloride Rituximab Doxorubicin |
Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |