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NCT Number: NCT06097364

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

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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study.

This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled).

The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study.

The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of 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 the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality-of-life and ability to complete routine daily activities

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Follicular Lymphoma (FL) Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Liverpool Hospital, Liverpool, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
  • For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
  • For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
  • For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
  • Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate bone marrow and hepatic function.

Key Exclusion Criteria:

  • Participants with central nervous system lymphoma or leptomeningeal lymphoma
  • Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
  • Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
  • Recent major surgery and history or organ transplantation
  • 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

Treatment and study plan

Odronextamab

Drug

Administered by intravenous (IV) infusion

Other names: REGN1979

Rituximab

Drug

Administered by IV infusion, or subcutaneous (SC)

Other names: Rituxan

Cyclophosphamide

Drug

Administered by IV infusion

Other names: Cytoxan

Doxorubicin

Drug

Administered by IV infusion

Other names: Adriamycin

Vincristine

Drug

Administered by IV infusion

Other names: Oncovin

Prednisone/Prenisolone

Drug

Administered orally (PO)

Other names: Deltasone/Omnipred

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy

    Time frame: Up to 35 days

    Part 1, DLT period

  2. Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy

    Time frame: Up to 2 years

    Part 1, Treatment period

  3. Severity of TEAEs of odronextamab in combination with chemotherapy

    Time frame: Up to 2 years

    Part 1, Treatment period

  4. Complete Response rate at 30 months (CR30) assessed by independent central review (ICR)

    Time frame: Up to 30 months

    Part 2

Secondary outcomes

  1. Odronextamab concentrations in serum when administered with chemotherapy

    Time frame: Up to 30 months

    Part 1, Maintenance period and Part 2, Induction period

  2. Odronextamab concentrations in serum when administered as monotherapy

    Time frame: Up to 30 months

    Part 1 and Part 2, Maintenance period

  3. Incidence of anti-odronextamab antibodies (ADAs)

    Time frame: Up to 30 months

    Part 1 and Part 2

  4. Titers of ADAs to odronextamab

    Time frame: Up to 30 months

    Part 1 and Part 2

  5. Incidence of neutralizing antibodies (NAb) to odronextamab

    Time frame: Up to 30 months

    Part 1 and Part 2

  6. Best overall response (BOR) as assessed by the investigator

    Time frame: Up to 30 months

    Part 1, end of Induction period and end of Maintenance period

  7. Progression free survival (PFS) as assessed by ICR

    Time frame: Up to 5 years

    Part 2

  8. CR30 as assessed by local investigator

    Time frame: Up to 30 months

    Part 2

  9. 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)

    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.

  10. PFS as assessed by local investigator

    Time frame: Up to 5 years

    Part 2

  11. Event-free survival (EFS) as assessed by ICR

    Time frame: Up to 5 years

    Part 2

  12. EFS as assessed by local investigator

    Time frame: Up to 5 years

    Part 2

  13. Overall Survival (OS)

    Time frame: Up to 5 years

    Part 2

  14. BOR as assessed by local investigator

    Time frame: Up to 30 months

    Part 2

  15. BOR as assessed by ICR

    Time frame: Up to 30 months

    Part 2

  16. Duration of response (DOR) assessed by ICR

    Time frame: Up to 5 years

    Part 2

  17. DOR as assessed by local investigator

    Time frame: Up to 5 years

    Part 2

  18. Time to next anti-lymphoma treatment (TTNT)

    Time frame: Up to 5 years

    Part 2

  19. Incidence of TEAEs

    Time frame: Up to 2 years

    Part 2

  20. Severity of TEAEs

    Time frame: Up to 2 years

    Part 2

  21. Change in patient reported health related quality of life (HRQoL) as measured by 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 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.

  22. Change in cancer disease as measured by 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 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.

  23. Change in treatment related symptoms as measured by 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 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.

  24. Change in patient-reported lymphoma disease as measured by the Lymphoma Subscale of the Functional Assessment of Cancer Treatment-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.

  25. Change in treatment-related symptoms as measured by the FACT-LymS

    Time frame: Up to 5 years

    Part 2 The FACT-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.

  26. Change in patient-reported general health status per EuroQol-5 Dimensions-5 Levels (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".

  27. Change in patient-reported treatment side effects burden per Functional Assessment of Cancer Therapy-General Global Population Item 5 (FACT-G GP5)

    Time frame: Up to 5 years

    Part 2 A single item 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).

  28. Change in 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).

  29. Change in 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.

  30. Change in score of the FACT-G GP5 item in the patient population

    Time frame: Up to 5 years

    Part 2 A single item 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).

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: OLYMPIA-2

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Oct 24, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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