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RecruitingNCT05730036LINKER-MM3Updated Sep 30, 2026

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

A Phase 3 interventional study of Linvoseltamab and Elotuzumab in Relapsed Refractory Multiple Myeloma (RRMM), sponsored by Regeneron Pharmaceuticals. Recruiting at 159 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is researching an experimental drug called linvoseltamab, also called REGN5458.

Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies).

This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd.

This study is looking at several other research questions, including:

  • How long participants benefit from receiving linvoseltamab compared with EPd
  • How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much
  • What side effects happen from taking linvoseltamab compared to EPd
  • How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd
  • If there is any improvement in pain after treatment with linvoseltamab compared to EPd
02

Conditions studied

  • Relapsed Refractory Multiple Myeloma (RRMM)

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Keywords

  • BCMA X CD3 Bispecific Monoclonal Antibody
  • CD38 antibody
  • Proteasome inhibitor
  • Lenalidomide
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.

  3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.

    Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.

  4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
  5. Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
  6. Life expectancy of at least 6 months

Key Exclusion Criteria:

  1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  2. Prior treatment with elotuzumab and/or pomalidomide
  3. Participants with known MM brain lesions or meningeal involvement
  4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
  5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
  6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
  7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).
  8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
  9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction \<40%.

NOTE: Other protocol defined inclusion/exclusion criteria apply

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
410 participants (estimated)

Study arms

  • Experimental
    Linvoseltamab

    Randomization 1:1

    Drug: Linvoseltamab

  • Active comparator
    Elotuzumab/Pomalidomide/Dexamethasone (EPd)

    Randomization 1:1

    Drug: Elotuzumab · Drug: Pomalidomide · Drug: Dexamethasone

Interventions

  • DrugLinvoseltamab

    REGN5458 will be administered by intravenous (IV) infusion

    Also known as: REGN5458, Lynozyfic™

  • DrugElotuzumab

    Elotuzumab will be administered by IV infusion

    Also known as: Empliciti

  • DrugPomalidomide

    Pomalidomide capsules will be administered by mouth (PO)

    Also known as: Pomalyst

  • DrugDexamethasone

    Dexamethasone tablets/capsules will be administered PO and/or by IV infusion

    Also known as: Decadron

05

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants

    Time frame: Up to approximatively 5 years

Secondary outcomes

  1. PFS per IMWG response criteria determined by IRC in all participants

    Time frame: Up to approximatively 5 years

  2. Objective Response (OR) of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants

    Time frame: Up to approximatively 5 years

  3. OR of CR or better per IMWG response criteria as determined by IRC in all participants

    Time frame: Up to approximatively 5 years

  4. Overall Survival (OS) in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  5. OS in all participants

    Time frame: Up to approximatively 5 years

  6. Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  7. Incidence of MRD negative status in all participants

    Time frame: Up to approximatively 5 years

  8. Mean change in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 in participants previously exposed to CD38 antibodies

    The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.

    Time frame: Baseline to week 12

  9. Mean change in the worst pain score measured by BPI-SF Item 3 in all participants

    The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.

    Time frame: Baseline to week 12

  10. Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  11. Incidence TEAEs in all participants

    Time frame: Up to approximatively 5 years

  12. Severity of TEAEs in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  13. Severity of TEAEs in all participants

    Time frame: Up to approximatively 5 years

  14. Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  15. Incidence of AESI in all participants

    Time frame: Up to approximatively 5 years

  16. Severity of AESI in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  17. Severity AESI in all participants

    Time frame: Up to approximatively 5 years

  18. Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  19. Incidence of SAE in all participants

    Time frame: Up to approximatively 5 years

  20. Severity of SAE in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  21. Severity of SAE in all participants

    Time frame: Up to approximatively 5 years

  22. PFS per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  23. PFS per IMWG response criteria as determined by the investigator in all participants

    Time frame: Up to approximatively 5 years

  24. OR of Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants

    Time frame: Up to approximatively 5 years

  25. OR of PR or better per IMWG response criteria as determined by the IRC in all participants

    Time frame: Up to approximatively 5 years

  26. OR of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants

    Time frame: Up to approximatively 5 years

  27. OR of VGPR or better per IMWG response criteria as determined by IRC in all participants

    Time frame: Up to approximatively 5 years

  28. OR of PR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  29. OR of PR or better per IMWG response criteria as determined by the investigator in all participants

    Time frame: Up to approximatively 5 years

  30. OR of VGPR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  31. OR of VGPR or better per IMWG response criteria as determined by the investigator in all participants

    Time frame: Up to approximatively 5 years

  32. OR of CR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  33. OR of CR or better per IMWG response criteria as determined by the investigator in all participants

    Time frame: Up to approximatively 5 years

  34. Duration of Response (DoR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  35. DoR as per IMWG response criteria as determined by the investigator in all participants

    Time frame: Up to approximatively 5 years

  36. DoR as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  37. DoR as per IMWG response criteria as determined by the IRC in all participants

    Time frame: Up to approximatively 5 years

  38. Duration of MRD negative status in the bone marrow in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  39. Duration of MRD negative status in the bone marrow in all participants

    Time frame: Up to approximatively 5 years

  40. Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  41. Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in all participants

    Time frame: Up to approximatively 5 years

  42. Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  43. Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in all participants

    Time frame: Up to approximatively 5 years

  44. Concentration of linvoseltamab in the serum over time in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  45. Concentration of linvoseltamab in the serum over time in all participants

    Time frame: Up to approximatively 5 years

  46. Incidence of antidrug antibodies (ADAs) in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  47. Incidence of ADAs in all participants

    Time frame: Up to approximatively 5 years

  48. Titer of ADAs in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  49. Titer of ADAs in all participants

    Time frame: Up to approximatively 5 years

  50. Incidence of neutralizing antibodies (Nabs) to linvoseltamab over time in participants previously exposed to CD38 antibodies

    Time frame: Up to approximatively 5 years

  51. Incidence of Nabs to linvoseltamab over time in all participants

    Time frame: Up to approximatively 5 years

  52. Proportion of Pain Responders in participants previously exposed to CD38 antibodies

    Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).

    Time frame: At week 12

  53. Proportion of Pain Responders in all participants

    Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).

    Time frame: At week 12

  54. Change in patient-reported global health status/quality of life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in participants previously exposed to CD38 antibodies

    The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."

    Time frame: Baseline to week 12

  55. Change in patient-reported QoL, per EORTC QLQ-C30 in all participants

    The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."

    Time frame: Baseline to week 12

  56. Change in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) in participants previously exposed to CD38 antibodies

    The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.

    Time frame: Baseline to week 12

  57. Change in patient reported disease symptoms per EORTC QLQ-MY20 in all participants

    The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.

    Time frame: Baseline to week 12

  58. Patient-Reported Outcomes in Patient Global Impression of Symptom Severity (PGIS) in participants previously exposed to CD38 antibodies

    The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe". The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.

    Time frame: Baseline to week 12

  59. Patient-Reported Outcomes in PGIS in all participants

    The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe". The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.

    Time frame: Baseline to week 12

  60. Patient-Reported Outcomes in Patient Global Impression of Change (PGIC) in participants previously exposed to CD38 antibodies

    The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change". The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.

    Time frame: Baseline to week 12

  61. Patient-Reported Outcomes in PGIC in all participants

    The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change". The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.

    Time frame: Baseline to week 12

  62. Change in patient-reported general health status per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) in participants previously exposed to CD38 antibodies

    The EQ-5D-5L consists of EQ-5D descriptive system comprises five 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.

    Time frame: Baseline to week 12

  63. Change in patient-reported general health status per EQ-5D-5L in all participants

    The EQ-5D-5L consists of EQ-5D descriptive system comprises five 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.

    Time frame: Baseline to week 12

06

Study locations

19 of 159 sites recruiting
  • University of California Los Angeles (UCLA)
    Los Angeles, California 90095, United States
    Active, not recruiting
  • University of Florida Division of Sponsored Programs
    Gainesville, Florida 32611, United States
    Withdrawn
  • University of Kentucky, Markey Cancer Center Clinical Research Organization
    Lexington, Kentucky 40536, United States
    Active, not recruiting
  • Norton Cancer Institute
    Louisville, Kentucky 40207, United States
    Active, not recruiting
  • Stony Brook University
    Stony Brook, New York 11794, United States
    Active, not recruiting
  • Levine Cancer Center
    Charlotte, North Carolina 28204, United States
    Active, not recruiting
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
    Withdrawn
  • Kaiser Permanente Northwest
    Portland, Oregon 97227, United States
    Active, not recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Active, not recruiting
  • University of Washington
    Seattle, Washington 98195, United States
    Active, not recruiting
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales 2050, Australia
    Active, not recruiting
  • Royal North Shore Hospital
    St Leonards, New South Wales 2065, Australia
    Active, not recruiting
  • Icon Cancer Centre - Wesley
    Auchenflower, Queensland 4066, Australia
    Active, not recruiting
  • Royal Brisbane and Women's Hospital
    Herston, Queensland 4029, Australia
    Active, not recruiting
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
    Active, not recruiting
  • Royal Hobart Hospital
    Hobart, Tasmania 7000, Australia
    Active, not recruiting
  • Launceston General Hospital
    Launceston, Tasmania 7250, Australia
    Active, not recruiting
  • St Vincent's Hospital
    Fitzroy, Victoria 3065, Australia
    Active, not recruiting
  • University Hospital Geelong
    Geelong, Victoria 3220, Australia
    Active, not recruiting
  • Austin Hospital
    Heidelberg, Victoria 3084, Australia
    Active, not recruiting
  • One Clinical Research at Hollywood Private Hospital
    Nedlands, Western Australia 6009, Australia
    Active, not recruiting
  • Clinique Universitaire de Mont Godinne
    Yvoir, Namur 5530, Belgium
    Completed
  • AZ Delta Algemeen Ziekenhuis Delta
    Roeselare, West-Vlaanderen 8800, Belgium
    Active, not recruiting
  • Ziekenhuis Netwerk Antwerpen Stuivenberg
    Antwerp, 2060, Belgium
    Active, not recruiting
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
    Withdrawn
  • IDOR - Sao Rafael Salvador Bahia
    Salvador, Estado de Bahia 41253-190, Brazil
    Active, not recruiting
  • Hospital Erasto Gaertner
    Curitiba, Paraná 81520-060, Brazil
    Active, not recruiting
  • Associacao Dr Bartholomeu Tacchini
    Bento Gonçalves, Rio Grande do Sul 95700-084, Brazil
    Active, not recruiting
  • Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    Active, not recruiting
  • Centro Gaucho Integrado
    Porto Alegre, Rio Grande do Sul 90110-270, Brazil
    Active, not recruiting
  • Animi Unidade de Tratamento Oncologico
    Lages, Santa Catarina 88501-001, Brazil
    Active, not recruiting
  • Instituto Americas de Ensino e Pesquisa
    Rio de Janeiro, 22793-080, Brazil
    Active, not recruiting
  • A Beneficencia Portuguesa de Sao Paulo, Oncology House
    São Paulo, 01321000, Brazil
    Active, not recruiting
  • Instituto DOr de Pesquisa e Ensino
    São Paulo, 01401-002, Brazil
    Active, not recruiting
  • AC Camargo Cancer Center
    São Paulo, 01509-010, Brazil
    Active, not recruiting
  • Clinica Medica Sao Germano
    São Paulo, 04537-080, Brazil
    Active, not recruiting
  • The Ottawa Hospital Cancer Centre
    Ottawa, Ontario K1H 8L6, Canada
    Active, not recruiting
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
    Active, not recruiting
  • University Health Network-Princess Margaret Cancer Center
    Toronto, Ontario M5G 2M9, Canada
    Active, not recruiting
  • Hospital Clinico Universidad de Los Andes
    Santiago, Las Condes 7620157, Chile
    Active, not recruiting
  • Clinica Alemana de Santiago
    Santiago, Santiago Metropolitan 6681920, Chile
    Active, not recruiting
  • Fundacion Arturo Lopez Perez
    Santiago, Santiago Metropolitan 7500921, Chile
    Active, not recruiting
  • Clinica UC San Carlos de Apoquindo
    Santiago, Santiago Metropolitan 7550000, Chile
    Active, not recruiting
  • Centro Oncologia de Precision Universidad Mayor
    Santiago, Santiago Metropolitan 7560907, Chile
    Active, not recruiting
  • Centro de Investigaciones Clinicas Vina del Mar
    Viña del Mar, Valparaiso 2540488, Chile
    Active, not recruiting
  • Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
    Lyon, Auvergne-Rhone 69008, France
    Active, not recruiting
  • Centre Francois Magendie
    Pessac, Gironde 33600, France
    Active, not recruiting
  • Centre Hospitalier Universitaire de Lille
    Lille, Hauts-de-France 59037, France
    Withdrawn
  • Hopital Saint Louis, APHP
    Paris, 75010, France
    Completed
  • Saint Antoine Hospital
    Paris, 75571, France
    Completed
  • Institut Curie
    Saint-Cloud, 92210, France
    Completed
  • Hopital Necker
    Paris, Île-de-France Region 75015, France
    Active, not recruiting
  • Gustave Roussy
    Villejuif, Île-de-France Region 94800, France
    Active, not recruiting
  • Medical Clinic II
    Tübingen, Baden-Wurttemberg 72076, Germany
    Active, not recruiting
  • Universitat zu Lubeck Neuromuskulares Zentrum
    Lübeck, Ratzeburger 23538, Germany
    Active, not recruiting
  • University Hospital Hamburg Eppendorf
    Hamburg, 20246, Germany
    Active, not recruiting
  • University Hospital Leipzig - Hematology and Cellular Therapy
    Leipzig, 4103, Germany
    Withdrawn
  • Rambam Health Care Campus
    Haifa, North 3109601, Israel
    Active, not recruiting
  • Lady Davis Carmel Medical Center
    Haifa, 3436212, Israel
    Active, not recruiting
  • Shaare Zedek Medical Center
    Jerusalem, 9103102, Israel
    Active, not recruiting
  • Hadassah Medical Center
    Jerusalem, 91120, Israel
    Active, not recruiting
  • Sheba Medical Center
    Ramat Gan, 52621, Israel
    Active, not recruiting
  • The Tel Aviv Sourasky Medical Center
    Tel Aviv, 64239, Israel
    Active, not recruiting
  • IRCCS Casa Sollievo della Sofferenza
    San Giovanni Rotondo, Foggia 71013, Italy
    Active, not recruiting
  • Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
    Meldola, Forli-Cesena 47014, Italy
    Active, not recruiting
  • Ospedale Policlinico San Martino IRCCS
    Genoa, Genova 16132, Italy
    Active, not recruiting
  • Azienda Ospedaliera Nazionale SS - Antonio e Biagio e Cesare Arrigo
    Alessandria, Piedmont 15121, Italy
    Active, not recruiting
  • A.O.U. Citta della Salute e della Scienza di Torino
    Turin, Piedmont 10126, Italy
    Active, not recruiting
  • IRCCS Fondazione Piemontese Oncologica Candiolo
    Candiolo, Torino 10060, Italy
    Active, not recruiting
  • AOU Ospedali Riuniti di Ancona
    Ancona, 60126, Italy
    Active, not recruiting
  • Policlinico S. Orsola- Malpighi
    Bologna, 40138, Italy
    Withdrawn
  • Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
    Catania, 95123, Italy
    Active, not recruiting
  • Universita degli Studi di Pavia - Fondazione IRCCS Policlini
    Pavia, 27100, Italy
    Active, not recruiting
  • Ospedale Santa Maria delle Croci
    Ravenna, 48121, Italy
    Active, not recruiting
  • AUSL IRCCS OF Reggio Emilia - Clinical Study Location -
    Reggio Emilia, 42123, Italy
    Active, not recruiting
  • Ospedale di Circolo e Fondazione Macchi Varese
    Varese, 21100, Italy
    Active, not recruiting
  • Aichi Medial University Hospital
    Nagakute, Aichi-ken 480-1195, Japan
    Recruiting
  • Chiba Cancer Center
    Chiba, Chiba 260-8717, Japan
    Recruiting
  • Kameda General Hospital
    Kamogawa, Chiba 296-8602, Japan
    Recruiting
  • National Cancer Center Hospital East
    Kashiwa-shi, Chiba 277-8577, Japan
    Recruiting
  • Kurume University Hospital
    Kurume, Fukuoka 830-0011, Japan
    Recruiting
  • Ogaki Municipal Hospital
    Ōgaki, Gifu 503-8502, Japan
    Recruiting
  • Gunma University Hospital
    Maebashi, Gunma 371-8511, Japan
    Recruiting
  • NHO Shibukawa Medical Center
    Shibukawa, Gunma 377-0280, Japan
    Recruiting
  • Sapporo Hokuyu Hospital
    Sapporo, Hokkaido 003-0006, Japan
    Recruiting
  • Iwate Medical University Hospital
    Shiwa-gun, Iwate 028-3694, Japan
    Recruiting
  • National Hospital Organization Kumamoto Medical Center
    Kumamoto, Kumamoto 860-0008, Japan
    Recruiting
  • National Hospital Organization Okayama Medical Center
    Kita-ku, Okayama-ken 701-1192, Japan
    Recruiting
  • Osaka University Hospital
    Suita-shi, Osaka 565-0871, Japan
    Recruiting
  • Saitama Medical University Hospital
    Iruma-gun, Saitama 350-0495, Japan
    Recruiting
  • Tokushima Prefectural Central Hospital
    Tokushima, Tokushima 770-8539, Japan
    Recruiting
  • Japanese Red Cross Medical Center
    Shibuya-ku, Tokyo 150-8935, Japan
    Recruiting
  • Yamanashi Prefectural Central Hospital
    Kofu, Yamanashi 400-8506, Japan
    Recruiting
  • Fukushima Medical University
    Fukushima, 960-1295, Japan
    Recruiting
  • National Hospital Organization Sendai Medical Center
    Sendai, 983-8520, Japan
    Recruiting
  • Radboudumc
    Nijmegen, Gelderland 6500HB, Netherlands
    Active, not recruiting
  • Albert Schweitzer Hospital
    Dordrecht, South Holland 3318 AT, Netherlands
    Active, not recruiting
  • University Clinical Center / Medical University of Gdansk
    Gdansk, Pomeranian Voivodeship 80-219, Poland
    Active, not recruiting
  • Szpital Uniwersytecki Nr2 Bydgoszcz
    Bydgoszcz, 85-168, Poland
    Completed
  • Pratia Onkologia Katowice
    Katowice, 40-519, Poland
    Active, not recruiting

Showing the first 100 of 159 sites across 18 countries.

07

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT05730036
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Feb 15, 2023
Start date
Sep 18, 2023
Primary completion
Apr 19, 2033 (estimated)
Completion
Apr 19, 2033 (estimated)
Last update
Sep 30, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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