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Een klinische studie van Zilovertamab vedotine (MK-2140) plus rituximab plus cyclofosfamide, doxorubicine en prednison (r-CHP) versus polatuzumab vedotine plus r-chp bij mensen met diffuse grote b-cell lymphoma (dLBL) (mk-2140-011/weveline-011)

12 november 2026 bijgewerkt door: Merck Sharp & Dohme LLC

Een gerandomiseerde, open-label, multicenter, fase 2-studie die de werkzaamheid en veiligheid van zilovertamab vedotine (MK-2140) plus R-CHP versus polatuzumab vedotine plus R-CHP evalueert in behandeling-naïeve deelnemers met GCB-subtype van diffuus groot B-cell lymphoma (DLBCL) (DLBCL) (DLBCL) (DLBCL) (DLBCL) (DLBCL) (DLBCL) (DLBCL) (DLBCL) (DLBCL)

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing.

The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

594

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • België
    • Antwerpen
      • Mechelen, Antwerpen, België, 2800
        • Werving
        • AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3215891669
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, België, 1200
        • Werving
        • Cliniques Universitaires Saint-Luc ( Site 0302)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3227641810
    • Hainaut
      • Haine-Saint-Paul, Hainaut, België, 7100
        • Werving
        • Hopital de Jolimont ( Site 0304)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3264231726
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, België, 9100
        • Werving
        • VITAZ ( Site 0307)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 3237602327
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, België, 3000
        • Werving
        • UZ Leuven ( Site 0301)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3216340938
    • West-Vlaanderen
      • Bruges, West-Vlaanderen, België, 8000
        • Werving
        • AZ Sint Jan Brugge-Oostende ( Site 0308)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3250452328
      • Roeselare, West-Vlaanderen, België, 8800
        • Werving
        • AZ Delta ( Site 0303)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +32(0)51237447
  • Duitsland
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Duitsland, 70174
        • Werving
        • Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltransplantation ( Site 0419)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4971127830410
      • Tübingen, Baden-Wurttemberg, Duitsland, 72076
        • Werving
        • UniversitaetsklInikum Tuebingen ( Site 0410)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4970712986018
      • Ulm, Baden-Wurttemberg, Duitsland, 89081
        • Werving
        • Universitaetsklinikum Ulm. ( Site 0404)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +49 731500 45 953
    • Bavaria
      • Erlangen, Bavaria, Duitsland, 91054
        • Werving
        • Uniklinik Erlangen ( Site 0412)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4991318535954
      • Munich, Bavaria, Duitsland, 81377
        • Werving
        • LMU Klinikum ( Site 0428)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 089440075212
      • Würzburg, Bavaria, Duitsland, 97080
        • Werving
        • Universitaetsklinikum Wuerzburg ( Site 0401)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4993120140013
    • Hesse
      • Frankfurt am Main, Hesse, Duitsland, 60389
        • Werving
        • Centrum für Hämatologie und Onkologie Bethanien ( Site 0417)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4969451080
      • Kassel, Hesse, Duitsland, 34125
        • Werving
        • Klinikum Kassel GmbH ( Site 0434)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +495619803046
    • Lower Saxony
      • Hanover, Lower Saxony, Duitsland, 30459
        • Werving
        • KRH Klinikum Siloah ( Site 0441)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4905119270
    • Mecklenburg-Vorpommern
      • Neubrandenburg, Mecklenburg-Vorpommern, Duitsland, 17036
        • Werving
        • Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +493957750
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Duitsland, 52074
        • Werving
        • Universitätsklinikum Aachen ( Site 0418)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0241 800
      • Bonn, North Rhine-Westphalia, Duitsland, 53113
        • Werving
        • Johanniter Krankenhaus Bonn ( Site 0440)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +492285433691
      • Wuppertal, North Rhine-Westphalia, Duitsland, 42283
        • Werving
        • HELIOS Klinikum Wuppertal ( Site 0435)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +492028960
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Duitsland, 56073
        • Werving
        • Gemeinschaftsklinikum Mittelrhein gGmbH Innere Medizin - Hamatologie/Onkologie.Palliativmedizin ( Site 0413)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 06772 8040
    • Saxony
      • Chemnitz, Saxony, Duitsland, 09113
        • Werving
        • Klinikum Chemnitz gGmbH ( Site 0405)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 01732988725
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Duitsland, 39120
        • Werving
        • Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 01732988725
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Duitsland, 23562
        • Werving
        • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4945150044777
    • Thuringia
      • Jena, Thuringia, Duitsland, 07747
        • Werving
        • Universitätsklinikum Jena ( Site 0438)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +493641 9327113
  • Ierland
      • Dublin, Ierland, D07 R2WY
        • Werving
        • Mater Misercordiae University Hospital ( Site 0501)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +353 1 8034831
      • Dublin, Ierland, D08 E9P6
        • Werving
        • St. James's Hospital ( Site 0505)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 014284934
      • Dublin, Ierland, D09 V2N0
        • Werving
        • Beaumont Hospital ( Site 0506)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 018092010
      • Limerick, Ierland, V94 F858
        • Werving
        • University Hospital Limerick ( Site 0503)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4461301111
      • Waterford, Ierland, X91 ER8E
        • Werving
        • University Hospital Waterford ( Site 0504)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +35351848000
    • Dublin
      • Dublin, Dublin, Ierland, D04 T6F4
        • Werving
        • St Vincent's University Hospital ( Site 0502)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +35312214000
  • Israël
      • Beersheba, Israël, 8410101
        • Werving
        • Soroka Medical Center ( Site 0606)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +97286400111
      • Haifa, Israël, 3109601
        • Werving
        • Rambam Health Care Campus ( Site 0604)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +972-47771514
      • Holon, Israël, 5810001
        • Werving
        • Edith Wolfson Medical Center ( Site 0602)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +972-508805538
      • Jerusalem, Israël, 9112001
        • Werving
        • Haddasah Medical Center ( Site 0601)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +97239377377
      • Petah Tikva, Israël, 4941492
        • Werving
        • Rabin Medical Center ( Site 0607)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +97239377377
      • Ramat Gan, Israël, 5265601
        • Werving
        • Sheba Medical Center ( Site 0603)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +972-35302127
      • Safed, Israël, 13100
        • Werving
        • ZIV Medical Center ( Site 0605)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +972-46828132
      • Tel Aviv, Israël, 6423906
        • Werving
        • Sourasky Medical Center ( Site 0608)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 972-3-6973576
  • Italië
      • Alessandria, Italië, 15121
        • Werving
        • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390131206262
      • Milan, Italië, 20141
        • Werving
        • Istituto Europeo di Oncologia ( Site 0701)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0390257489403
      • Naples, Italië, 80131
        • Werving
        • Universita degli Studi di Napoli Federico II ( Site 0705)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390817462037
      • Reggio Emilia, Italië, 42123
        • Werving
        • Arcispedale Santa Maria Nuova ( Site 0706)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +39 0522295654
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italië, 47014
        • Werving
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390543739266
    • Milano
      • Rozzano, Milano, Italië, 20089
        • Werving
        • Istituto Clinico Humanitas ( Site 0704)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390282244540
    • Sicily
      • Palermo, Sicily, Italië, 90146
        • Werving
        • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390917802047
  • Japan
      • Nagasaki, Japan, 852-8501
        • Werving
        • Nagasaki University Hospital ( Site 1008)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-95-819-7256
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Werving
        • Aichi Cancer Center ( Site 1007)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-52-762-6111
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Werving
        • Fujita Health University Hospital ( Site 1003)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-562-93-2111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Werving
        • Hokkaido University Hospital ( Site 1004)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-11-716-1161
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
        • Werving
        • National Hospital Organization Sendai Medical Center ( Site 1005)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-22-293-1111
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Werving
        • Kansai Medical University Hospital ( Site 1006)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-72-804-2808
    • Shimane
      • Izumo, Shimane, Japan, 693-8501
        • Werving
        • Shimane University Hospital ( Site 1002)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-853-20-2492
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8603
        • Werving
        • Nippon Medical School Hospital ( Site 1001)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-3-3822-2131
      • Chūō, Tokyo, Japan, 104-0045
        • Werving
        • National Cancer Center Hospital ( Site 1009)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-3-3542-2511
  • Polen
    • Greater Poland Voivodeship
      • Skórzewo, Greater Poland Voivodeship, Polen, 60-185
        • Werving
        • AIDPORT Sp. z o.o. ( Site 0808)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48570783100
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 30-727
        • Werving
        • Pratia MCM Krakow ( Site 0804)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48 12 295 81 60
      • Nowy Sącz, Lesser Poland Voivodeship, Polen, 33-300
        • Werving
        • Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48 18 443 88 77
    • Lower Silesian Voivodeship
      • Wałbrzych, Lower Silesian Voivodeship, Polen, 58-309
        • Werving
        • Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0807)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48746489742
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-781
        • Werving
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 225462223
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80-214
        • Werving
        • Uniwersyteckie Centrum Kliniczne ( Site 0802)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48 58 584 43 57
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polen, 40-519
        • Werving
        • Pratia Onkologia Katowice ( Site 0801)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48 501 714 019
  • Verenigd Koninkrijk
      • Birmingham, Verenigd Koninkrijk, B15 2TH
        • Werving
        • Queen Elizabeth Hospital Birmingham ( Site 0912)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441213717842
      • Liverpool, Verenigd Koninkrijk, L7 8YA
        • Werving
        • Clatterbridge Cancer Centre - Liverpool ( Site 0911)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441515565000
      • Manchester, Verenigd Koninkrijk, M20 4BX
        • Werving
        • Christie Hospital NHS Trust ( Site 0901)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441619187222
    • Bristol, City of
      • Bristol, Bristol, City of, Verenigd Koninkrijk, BS2 8ED
        • Werving
        • Bristol Haematology and Oncology Centre ( Site 0908)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441179230000
    • Buckinghamshire
      • Aylesbury, Buckinghamshire, Verenigd Koninkrijk, HP21 8AL
        • Werving
        • Stoke Mandeville Hospital ( Site 0917)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441296315000
    • Devon
      • Exeter, Devon, Verenigd Koninkrijk, EX2 5DW
        • Werving
        • Royal Devon & Exeter Hospital ( Site 0910)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 01392402850
      • Plymouth, Devon, Verenigd Koninkrijk, PL68DH
        • Werving
        • University Hospitals Plymouth NHS Trust ( Site 0905)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441752431043
    • England
      • Middlesbrough, England, Verenigd Koninkrijk, TS4 3BW
        • Werving
        • The James Cook University Hospital ( Site 0909)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441642850850
    • Lincolnshire
      • Lincoln, Lincolnshire, Verenigd Koninkrijk, LN2 5QY
        • Werving
        • Lincoln County Hospital ( Site 0906)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441522573557
    • London, City of
      • London, London, City of, Verenigd Koninkrijk, W12 0 HS
        • Werving
        • Hammersmith Hospital ( Site 0915)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +442033134594
      • London, London, City of, Verenigd Koninkrijk, SE1 9RT
        • Werving
        • Guy s & St Thomas NHS Foundation Trust ( Site 0904)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +442071887188
    • Oxfordshire
      • Oxford, Oxfordshire, Verenigd Koninkrijk, OX3 7LJ
        • Werving
        • Churchill Hospital ( Site 0903)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441865227063
  • Verenigde Staten
    • Alabama
      • Mobile, Alabama, Verenigde Staten, 36607
        • Werving
        • Infirmary Cancer Care ( Site 0157)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 251-435-2273
    • Arizona
      • Chandler, Arizona, Verenigde Staten, 85224
        • Werving
        • Ironwood Cancer & Research Centers ( Site 0204)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 480-314-6670
      • Glendale, Arizona, Verenigde Staten, 85304
        • Werving
        • Palo Verde Cancer Specialists ( Site 0105)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 602-978-6255
      • Goodyear, Arizona, Verenigde Staten, 85338
        • Werving
        • City of Hope - Phoenix ( Site 0202)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 602-883-1537
    • Arkansas
      • Hot Springs, Arkansas, Verenigde Staten, 71913
        • Werving
        • Genesis Cancer and Blood Institute ( Site 0193)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 501-624-7700
    • California
      • Burbank, California, Verenigde Staten, 91505
        • Werving
        • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 818-840-0921
      • Duarte, California, Verenigde Staten, 91010
        • Werving
        • City of Hope Comprehensive Cancer Center ( Site 0191)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 626-218-2405
      • La Jolla, California, Verenigde Staten, 92093
        • Werving
        • Moores Cancer Center ( Site 0187)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 858-822-6100
      • Walnut Creek, California, Verenigde Staten, 94598
        • Werving
        • Bass Medical Group ( Site 0123)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 925-433-8786
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80012
        • Werving
        • Rocky Mountain Cancer Centers (RMCC) ( Site 8001)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 303-925-0700
      • Grand Junction, Colorado, Verenigde Staten, 81505
        • Werving
        • Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 970-644-4460
    • Delaware
      • Newark, Delaware, Verenigde Staten, 19713
        • Werving
        • Medical Oncology Hematology Consultants (MOHC) ( Site 8007)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 302-366-1200
    • District of Columbia
      • Washington D.C., District of Columbia, Verenigde Staten, 20007
        • Werving
        • Georgetown University Medical Center ( Site 0117)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 202-444-2223
    • Florida
      • Boca Raton, Florida, Verenigde Staten, 33486
        • Werving
        • Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 561-955-4800
      • Jacksonville, Florida, Verenigde Staten, 32207
        • Werving
        • Baptist MD Anderson Cancer Center ( Site 0176)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 904-202-7300
      • Miami Beach, Florida, Verenigde Staten, 33140
        • Werving
        • Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 305-674-2625
      • Orange City, Florida, Verenigde Staten, 32763
        • Werving
        • Mid Florida Hematology and Oncology Center ( Site 0152)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 386-774-1223
    • Idaho
      • Post Falls, Idaho, Verenigde Staten, 83854
        • Werving
        • Beacon Cancer Care ( Site 0142)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 208-755-2804
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
        • Werving
        • University of Chicago Medical Center ( Site 0126)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 773-702-5550
      • Peoria, Illinois, Verenigde Staten, 61615
        • Werving
        • Illinois Cancer Care ( Site 7005)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 309-240-6040
    • Iowa
      • Iowa City, Iowa, Verenigde Staten, 52242
        • Werving
        • University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 319-356-4200
      • Waukee, Iowa, Verenigde Staten, 50263
        • Werving
        • Mission Blood & Cancer Care ( Site 0114)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 515-282-2921
    • Kentucky
      • Edgewood, Kentucky, Verenigde Staten, 41017
        • Werving
        • Saint Elizabeth Medical Center Edgewood ( Site 0141)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 859-301-2000
      • Elizabethtown, Kentucky, Verenigde Staten, 42701
        • Werving
        • Baptist Health Hardin ( Site 0154)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 270-706-5065
      • Lexington, Kentucky, Verenigde Staten, 40503
        • Werving
        • Baptist Health Lexington ( Site 0127)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 859-260-6100
      • Louisville, Kentucky, Verenigde Staten, 40207
        • Werving
        • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 502-899-3366
    • Louisiana
      • Baton Rouge, Louisiana, Verenigde Staten, 70808
        • Werving
        • Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 225-374-0320
      • Monroe, Louisiana, Verenigde Staten, 71202
        • Werving
        • Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 318-330-0000
      • New Orleans, Louisiana, Verenigde Staten, 70121
        • Werving
        • Ochsner Clinic Foundation ( Site 0189)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 504-703-1340
      • Shreveport, Louisiana, Verenigde Staten, 71103
        • Werving
        • Louisiana State University Health Sciences Shreveport ( Site 0195)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 318-813-1057
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Werving
        • Dana Farber Cancer Institute ( Site 0111)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 877-442-3324
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Werving
        • Beth Israel Deaconess Medical Center ( Site 0161)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 617-667-2100
    • Minnesota
      • Burnsville, Minnesota, Verenigde Staten, 55337
        • Actief, niet wervend
        • Minnesota Oncology Hematology (MNO) ( Site 8004)
    • Montana
      • Bozeman, Montana, Verenigde Staten, 59715
        • Werving
        • Bozeman Health Deaconess Hospital ( Site 0183)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 406-414-3749
    • Nebraska
      • Lincoln, Nebraska, Verenigde Staten, 68506
        • Werving
        • NHO Revive Research Institute, LLC ( Site 0121)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 402-484-4900
      • Omaha, Nebraska, Verenigde Staten, 68198
        • Werving
        • University Of Nebraska Medical Center ( Site 0110)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 402-559-5600
    • New Jersey
      • Morristown, New Jersey, Verenigde Staten, 07960
        • Werving
        • Atlantic Health Morristown Medical Center ( Site 0163)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 973-971-6608
      • Paramus, New Jersey, Verenigde Staten, 07652
        • Werving
        • Valley Health Systems - Ridgewood Campus ( Site 0125)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 201-447-8000
    • New York
      • Buffalo, New York, Verenigde Staten, 14263
        • Werving
        • Roswell Park Cancer Institute ( Site 0192)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 716-845-2300
      • Buffalo, New York, Verenigde Staten, 14215
        • Voltooid
        • Erie County Medical Center ( Site 0175)
      • Mineola, New York, Verenigde Staten, 11501
        • Werving
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 516-663-2988
      • New York, New York, Verenigde Staten, 10016
        • Werving
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 212-731-6000
      • Syracuse, New York, Verenigde Staten, 13210
        • Werving
        • SUNY Upstate Cancer Center ( Site 0178)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 315-464-8200
      • Westbury, New York, Verenigde Staten, 11590
        • Werving
        • Optum Medical Care, PC ( Site 0122)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 646-872-8630
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27514
        • Werving
        • University of North Carolina Medical Center ( Site 0136)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 984-974-1000
      • Charlotte, North Carolina, Verenigde Staten, 28204
        • Werving
        • Novant Health Presbyterian Medical Center ( Site 0177)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 704-384-4000
      • Winston-Salem, North Carolina, Verenigde Staten, 27103
        • Werving
        • Novant Health Forsyth Medical Center ( Site 0206)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 336-718-5000
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45219
        • Werving
        • University of Cincinnati Medical Center ( Site 0156)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 513-584-1000
      • Cleveland, Ohio, Verenigde Staten, 44195
        • Werving
        • Cleveland Clinic Main ( Site 0101)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 216-444-6833
      • Cleveland, Ohio, Verenigde Staten, 44111
        • Werving
        • Fairview Hospital-Moll Cancer Center ( Site 0198)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 216-444-6833
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Werving
        • University Hospitals of Cleveland ( Site 0155)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 216-286-3867
      • Mayfield Heights, Ohio, Verenigde Staten, 44124
        • Werving
        • Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 216-444-6833
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97213
        • Werving
        • Providence Portland Medical Center ( Site 0120)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 503-216-6300
      • Portland, Oregon, Verenigde Staten, 97225
        • Werving
        • Providence Oncology and Hematology Clinic Westside ( Site 0179)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 503-216-6300
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19140
        • Werving
        • Temple University Hospital ( Site 0133)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 215-707-8712
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Werving
        • Abramson Cancer Center and Perelman Center for Advanced Medicine ( Site 0131)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 215-662-2867
      • Sellersville, Pennsylvania, Verenigde Staten, 18960
        • Werving
        • Alliance Cancer Specialists (ACS) ( Site 8010)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 215-706-2034
      • York, Pennsylvania, Verenigde Staten, 17403
        • Werving
        • Cancer Care Associates Of York ( Site 0174)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 484-371-5102
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Werving
        • Medical University of South Carolina ( Site 0153)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 843-792-2529
    • Tennessee
      • Knoxville, Tennessee, Verenigde Staten, 37909
        • Werving
        • Tennessee Cancer Specialists ( Site 7004)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 865-862-0998
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Werving
        • SCRI Oncology Partners ( Site 7002)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 615-329-7274
    • Texas
      • Amarillo, Texas, Verenigde Staten, 79124
        • Werving
        • Texas Oncology - West Texas ( Site 8008)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 806-358-8654
      • Austin, Texas, Verenigde Staten, 78705
        • Werving
        • Texas Oncology - Central/South Texas ( Site 8006)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 512-427-9400
      • Dallas, Texas, Verenigde Staten, 75390
        • Werving
        • UT Southwestern Medical Center ( Site 0190)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 214-648-3111
      • Palestine, Texas, Verenigde Staten, 75801
        • Werving
        • Texas Oncology - Northeast Texas ( Site 8002)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 903-727-2200
      • San Antonio, Texas, Verenigde Staten, 78240
        • Werving
        • Texas Oncology - San Antonio ( Site 8009)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 210-595-5300
      • Tyler, Texas, Verenigde Staten, 75701
        • Voltooid
        • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)
    • Utah
      • Murray, Utah, Verenigde Staten, 84107
        • Werving
        • Intermountain Medical Center ( Site 0182)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 801-507-3630
      • St. George, Utah, Verenigde Staten, 84790
        • Werving
        • Intermountain Healthcare - St. George ( Site 0203)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 801-507-3630
    • Virginia
      • Manassas, Virginia, Verenigde Staten, 20110
        • Werving
        • Virginia Cancer Specialists, PC ( Site 8003)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 703-554-6800
      • Richmond, Virginia, Verenigde Staten, 23219
        • Werving
        • VCU Health Adult Outpatient Pavillion ( Site 0138)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 315-383-8748
    • Washington
      • Vancouver, Washington, Verenigde Staten, 98684
        • Werving
        • Northwest Cancer Specialists (Compass Oncology) ( Site 8000)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 360-944-9889
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten, 53715
        • Werving
        • SSM Health Dean Medical Group ( Site 0106)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 608-252-8000
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Werving
        • Medical College of Wisconsin ( Site 0103)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 414-805-6700

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues.
  • Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
  • Has received no prior treatment for their DLBCL.
  • Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization.
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has a history of transformation of indolent disease to DLBCL.
  • Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.
  • Has Ann Arbor Stage I DLBCL.
  • Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
  • Has clinically significant pericardial or pleural effusion.
  • Has ongoing Grade >1 peripheral neuropathy.
  • Has a demyelinating form of Charcot-Marie-Tooth disease.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Has ongoing corticosteroid therapy.
  • Known additional malignancy that is progressing or has required active treatment within the past 2 years.
  • Known active central nervous system (CNS) lymphoma.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has active infection requiring systemic therapy.
  • Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
  • Has history of stem cell/solid organ transplant.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)

Participants will receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 375 mg/m^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).
Biologisch: Rituximab

IV infusion

Andere namen:
  • RITUXAN®
Geneesmiddel: Cyclophosphamide

IV infusion

Andere namen:
  • CYTOXAN®
  • NEOSAR®
Biologisch: Zilovertamab vedotin

IV infusion

Andere namen:
  • MK-2140
  • VLS-101
Geneesmiddel: Doxorubicin

IV infusion

Andere namen:
  • ADRIAMYCIN®
Biologisch: Rituximab Biosimilar

IV infusion

Andere namen:
  • TRUXIMA®
  • RUXIENCE®
  • RIABNI®
Geneesmiddel: Prednisone

Oral administration or IV infusion

Geneesmiddel: Prednisolone

Oral administration or IV infusion

Geneesmiddel: Rescue Medication

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Actieve vergelijker: Polatuzumab vedotin + R-CHP

Participants will receive a dose of polatuzumab vedotin (1.8 mg/kg) plus 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 375 mg/m^2 rituximab or rituximab biosimilar administered by IV infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).
Biologisch: Rituximab

IV infusion

Andere namen:
  • RITUXAN®
Geneesmiddel: Cyclophosphamide

IV infusion

Andere namen:
  • CYTOXAN®
  • NEOSAR®
Geneesmiddel: Doxorubicin

IV infusion

Andere namen:
  • ADRIAMYCIN®
Biologisch: Rituximab Biosimilar

IV infusion

Andere namen:
  • TRUXIMA®
  • RUXIENCE®
  • RIABNI®
Geneesmiddel: Prednisone

Oral administration or IV infusion

Geneesmiddel: Prednisolone

Oral administration or IV infusion

Geneesmiddel: Rescue Medication

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Biologisch: Polatuzumab vedotin

IV infusion

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria
Tijdsspanne: Up to approximately 31 months

CRR at EOT is defined as the percentage of participants who experience complete response (CR) per Lugano response criteria as assessed by blinded independent central review (BICR) at end of treatment. CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Participants with missing data or who discontinue treatment or study prior to reaching EOT will be considered non-responders and included in the total number of participants.
Up to approximately 31 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free Survival (PFS) per Lugano Response Criteria
Tijdsspanne: Up to approximately 51 months

PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by BICR or death due to any cause, whichever occurs first.
Up to approximately 51 months
Overall Survival (OS)
Tijdsspanne: Up to approximately 87 months

OS is defined as the time from randomization to death due to any cause.
Up to approximately 87 months
Event-free Survival (EFS) per Lugano Response Criteria
Tijdsspanne: Up to approximately 51 months

EFS is defined as the time from randomization to any of the following events: progressive disease per Lugano response criteria by BICR, death due to any cause, initiation of a new anti-caner therapy, or a positive biopsy for residual disease. The EFS for all participants will be presented.
Up to approximately 51 months
Duration of CR
Tijdsspanne: Up to approximately 51 months

For participants who demonstrate CR at EOT per Lugano response criteria by BICR, duration of complete response is defined as the time from the first documented evidence of CR at or before EOT until disease progression or death due to any cause, whichever occurs first.
Up to approximately 51 months
Number of participants who experience one or more adverse events (AEs)
Tijdsspanne: Up to approximately 9 months

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
Up to approximately 9 months
Number of participants who discontinue study intervention due to an AE
Tijdsspanne: Up to approximately 6 months

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
Up to approximately 6 months
Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI)
Tijdsspanne: Baseline and up to Week 25

The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.
Baseline and up to Week 25
Change From Baseline in HRQoL on FACT-Lym Total Score
Tijdsspanne: Baseline and up to Week 25

The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.
Baseline and up to Week 25
Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 through GP7)
Tijdsspanne: Baseline and up to Week 25

The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.
Baseline and up to Week 25
Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
Tijdsspanne: Baseline and up to Week 25

The FACT/GOG-NTX provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. It is an 11-item questionnaire designed to measure the neurotoxicity subscale. The scoring of FACT/GOG-NTX is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. To produce a Neurotoxicity Subscale score (range 0-44), the sum of the item scores are multiplied by the number of items in the subscale, then divided by the number of items answered.
Baseline and up to Week 25

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 april 2025

Primaire voltooiing (Geschat)

13 december 2027

Studie voltooiing (Geschat)

16 december 2032

Studieregistratiedata

Eerst ingediend

20 maart 2025

Eerst ingediend dat voldeed aan de QC-criteria

20 maart 2025

Eerst geplaatst (Werkelijk)

24 maart 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

12 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2140-011
  • U1111-1309-2852 (Register-ID: UTN)
  • MK-2140-011 (Andere identificatie: MSD)
  • waveLINE-011 (Andere identificatie: MSD)
  • 2024-515526-89-00 (Register-ID: EU CT)
  • jRCT2021250001 (Register-ID: Japan Registry of Clinical Trials (jRCT))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren