Clincosm LogoSign in Get a demo

OLYMPIA-1: 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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06091254
Collaborator
(none)
478
Enrollment
1
Location
2
Arms
65
Anticipated Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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)
Anticipated Study Start Date :
Oct 13, 2023
Anticipated Primary Completion Date :
Mar 14, 2029
Anticipated Study Completion Date :
Mar 14, 2029

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • REGN1979

    		•
    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.

    Drug: Rituximab
    Rituximab will be administered by IV, or subcutaneously (SC)
    Other Names:
  • Rituxan

    • Drug: Cyclophosphamide
    Administered by IV as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
    Other Names:
  • Cytoxan

    • Drug: Doxorubicin
    Administered by IV as part of CHOP chemotherapy
    Other Names:
  • Adriamycin

    • Drug: Vincristine
    Administered by IV as part of CHOP, and CVP chemotherapy
    Other Names:
  • Oncovin

    • Drug: Prednisone/prednisolone
    Administered orally (PO) as part of CVP chemotherapy
    Other Names:
  • Deltasone/Omnipred

    • Drug: Bendamustine
    Administered by IV as part of chemotherapy (Rituximab-Bendamustine)
    Other Names:
  • Treanda

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of dose-limiting toxicities (DLTs) for odronextamab [Up to 35 days]

      Part 1

    2. Incidence of treatment-emergent adverse events (TEAEs) of odronextamab [Up to 2 years]

      Part 1

    3. Severity of TEAEs of odronextamab [Up to 2 years]

      Part 1

    4. Complete Response at 30 months (CR30) as assessed by independent central review [Up to 30 months]

      Part 2

    Secondary Outcome Measures

    1. Concentrations of odronextamab in serum [Up to 30 months]

      Part 1

    2. Incidence of anti-odronextamab antibodies (ADAs) [Up to 30 months]

      Part 1

    3. Titer of ADAs [Up to 30 months]

      Part 1

    4. Incidence of neutralizing antibodies (NAbs) to odronextamab [Up to 30 months]

      Part 1

    5. Objective response as assessed by the investigator [Up to 30 months]

      Part 1

    6. Progression-free survival (PFS) as assessed by independent central review [Up to 5 years]

      Part 2

    7. Event-free survival (EFS) as assessed by independent central review [Up to 5 years]

      Part 2

    8. CR30 as assessed by local investigator [Up to 30 months]

      Part 2

    9. 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)] [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.

    10. Overall survival (OS) [Up to 5 years]

      Part 2

    11. PFS as assessed by the local investigator [Up to 5 years]

      Part 2

    12. EFS as assessed by the local investigator [Up to 5 years]

      Part 2

    13. Objective response assessed by local investigator [Up to 30 months]

      Part 2

    14. Objective response assessed by independent central review [Up to 30 months]

      Part 2

    15. Duration of response (DOR) assessed by independent central review [Up to 5 years]

      Part 2

    16. DOR assessed by local investigator [Up to 5 years]

      Part 2

    17. Time to next anti-lymphoma treatment (TTNT) [Up to 5 years]

      Part 2

    18. Incidence of TEAEs [Up to 2 years]

      Part 2

    19. Severity of TEAEs [Up to 2 years]

      Part 2

    20. Odronextamab concentrations in serum during the induction period [Up to 30 months]

      Part 2

    21. Odronextamab concentrations in serum during the maintenance period [Up to 30 months]

      Part 2

    22. Incidence of ADAs to odronextamab over time [Up to 30 months]

      Part 2

    23. Titer of ADAs to odronextamab over time [Up to 30 months]

      Part 2

    24. Incidence of NAbs to odronextamab over time [Up to 30 months]

      Part 2

    25. Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30 [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.

    26. Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS) [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.

    27. Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Severity (PGIS) [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).

    28. Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Change (PGIC) [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.

    29. Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L) [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".

    30. Overall mean changes in scores PROs, as measured by the validated Functional Assessment of Cancer - General (FACT-G) global population 5 (GP5) question [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).

    31. Change in score of the GP5 item in the participant population [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Alliance Inc Westbury New York United States 11590

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT06091254
    Other Study ID Numbers:
    • R1979-HM-2298
    • 2022-502660-20-00
    First Posted:
    Oct 19, 2023
    Last Update Posted:
    Oct 19, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Regeneron Pharmaceuticals
    Non-Hodgkin lymphomas (NHLs)
    Indolent NHL
    B-cells NHL (B-NHL)
    Follicular lymphoma
    Odronextamab
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular
    Prednisone
    Prednisolone
    Cyclophosphamide
    Bendamustine Hydrochloride
    Rituximab
    Doxorubicin
    Vincristine

    Study Results

    No Results Posted as of Oct 19, 2023