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Recruiting nowPhase 1/2Ages 6 Months to 25 Years

Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)

Sponsor: Merck Sharp & Dohme LLC · NCT06395103 on ClinicalTrials.gov ↗

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Conditions studied

B-cell Acute Lymphoblastic LeukemiaDiffuse Large B-cell LymphomaBurkitt LymphomaNeuroblastomaEwing Sarcoma

What it tests

  • Zilovertamab vedotinbiological

Where it's running70 sites

  • Children's Hospital Los Angeles ( Site 1006)

    Los Angeles, California 90027

    Recruiting now

  • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)

    Aurora, Colorado 80045

    Recruiting now

  • Yale New Haven Hospital ( Site 1012)

    New Haven, Connecticut 06510

    Recruiting now

  • Johns Hopkins All Children's Hospital ( Site 1025)

    St. Petersburg, Florida 33701

    Recruiting now

  • University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)

    Iowa City, Iowa 52242

    Recruiting now

  • Dana-Farber Cancer Institute ( Site 1013)

    Boston, Massachusetts 02215

    Recruiting now

  • Corewell Health ( Site 1001)

    Grand Rapids, Michigan 49503

    Recruiting now

  • Children's Mercy Hospital ( Site 1024)

    Kansas City, Missouri 64108

    Recruiting now

  • Rutgers Cancer Institute of New Jersey ( Site 1008)

    New Brunswick, New Jersey 08903

    Recruiting now

  • Memorial Sloan Kettering Cancer Center ( Site 1010)

    New York, New York 10065

    Recruiting now

  • New York Medical College ( Site 1023)

    Valhalla, New York 10595

    Recruiting now

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)

    Fargo, North Dakota 58102

    Recruiting now

  • Oregon Health and Science University ( Site 1004)

    Portland, Oregon 97239

    Recruiting now

  • Children's Hospital of Philadelphia (CHOP) ( Site 1021)

    Philadelphia, Pennsylvania 19104

    Recruiting now

  • Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)

    Sioux Falls, South Dakota 57105

    Recruiting now

  • University of Texas MD Anderson Cancer Center ( Site 1007)

    Houston, Texas 77030

    Recruiting now

  • Intermountain - Primary Children's Hospital ( Site 1014)

    Salt Lake City, Utah 84113

    Recruiting now
53 international sites

  • Sydney Children's Hospital ( Site 1997)

    Randwick, New South Wales, Australia 2031

    Recruiting now

  • Queensland Children's Hospital-Oncology & Haematology ( Site 1996)

    Brisbane, Queensland, Australia 4101

    Recruiting now

  • Royal Children's Hospital-Children's Cancer Centre ( Site 1994)

    Melbourne, Victoria, Australia 3052

    Recruiting now

  • UZ Gent ( Site 1428)

    Ghent, Oost-Vlaanderen, Belgium 9000

    Recruiting now

  • Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268)

    Curitiba, Paraná, Brazil 81520-060

    Completed

  • Hospital de Clinicas de Porto Alegre ( Site 1265)

    Porto Alegre, Rio Grande do Sul, Brazil 90035-903

    Recruiting now

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264)

    Barretos, São Paulo, Brazil 14784400

    Recruiting now

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1267)

    São José do Rio Preto, São Paulo, Brazil 15090000

    Recruiting now

  • The Hospital for Sick Children ( Site 1225)

    Toronto, Ontario, Canada M5G 1X8

    Recruiting now

  • McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)

    Montreal, Quebec, Canada H4A 3J1

    Recruiting now

  • Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881)

    Concepción, Biobio, Chile 4070038

    Recruiting now

  • Hospital Luis Calvo Mackenna ( Site 1879)

    Santiago, Region M. de Santiago, Chile 7500539

    Recruiting now

  • Hospital Carlos Van Buren ( Site 1880)

    Valparaíso, Valparaiso, Chile 2341131

    Recruiting now

  • Hospital Pablo Tobon Uribe ( Site 1923)

    Medellín, Antioquia, Colombia 050034

    Recruiting now

  • Clinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924)

    Barranquilla, Atlántico, Colombia 080020

    Recruiting now

  • IMAT S.A.S ( Site 1921)

    Montería, Departamento de Córdoba, Colombia 230002

    Recruiting now

  • Detska nemocnice FN Brno ( Site 1388)

    Brno, Brno-mesto, Czechia 613 00

    Recruiting now

  • Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 1387)

    Prague, Praha 5, Czechia 150 00

    Recruiting now

  • Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 1467)

    Copenhagen, Capital Region, Denmark DK-2100

    Recruiting now

  • CHU de Bordeaux. Hopital Pellegrin ( Site 1105)

    Bordeaux, Aquitaine, France 33076

    Recruiting now

  • CENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100)

    Lyon, Auvergne-Rhône-Alpes, France 69373

    Recruiting now

  • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1104)

    Nantes, Loire-Atlantique, France 44093

    Recruiting now

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1102)

    Marseille, Provence-Alpes-Côte d'Azur Region, France 13005

    Recruiting now

  • Gustave Roussy ( Site 1103)

    Villejuif, Île-de-France Region, France 94805

    Recruiting now

  • Universitaetsklinikum Tuebingen ( Site 1142)

    Tübingen, Baden-Wurttemberg, Germany 72076

    Recruiting now

  • Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 1145)

    Cologne, North Rhine-Westphalia, Germany 50937

    Recruiting now

  • Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Site 1141)

    Münster, North Rhine-Westphalia, Germany 48149

    Recruiting now

  • Charité Campus Virchow-Klinikum-Klinik für Pädiatrie mit Schwerpunkt Hämatologie und Onkologie ( Site 1143)

    Berlin, Germany 13353

    Recruiting now

  • Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 1797)

    Athens, Attica, Greece 115 27

    Recruiting now

  • Semmelweis Egyetem ( Site 1838)

    Budapest, Hungary 1085

    Recruiting now

  • Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)

    Haifa, Israel 3109601

    Recruiting now

  • Sheba Medical Center ( Site 1675)

    Ramat Gan, Israel 5265601

    Recruiting now

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Pediatric Oncology ( Site 1552)

    Milan, Lombardy, Italy 20133

    Recruiting now

  • Ospedale Pediatrico Bambino Gesù IRCCS-Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica ( Site 1553)

    Rome, Roma, Italy 00165

    Recruiting now

  • Ospedale Infantile Regina Margherita-S.C. Oncoematologia Pediatrica ( Site 1551)

    Torino, Italy 10126

    Recruiting now

  • Prinses Maxima Centrum voor Kinderoncologie ( Site 1510)

    Utrecht, Netherlands 3584 CS

    Recruiting now

  • Narodny ustav detskych chorob ( Site 1592)

    Bratislava, Bratislava Region, Slovakia 831 01

    Recruiting now

  • Seoul National University Hospital-Pediatrics ( Site 1972)

    Seoul, South Korea 03080

    Recruiting now

  • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)

    Seoul, South Korea 05505

    Recruiting now

  • Hospital Sant Joan de Déu-Pediatric Oncology Department ( Site 1717)

    Esplugas de Llobregat, Barcelona, Spain 08950

    Recruiting now

  • Hospital Infantil Universitario Niño Jesús-Servicio de Onco-Hematología Pediátrica ( Site 1715)

    Madrid, Madrid, Comunidad de, Spain 28009

    Recruiting now

  • Hospital Universitario y Politecnico La Fe de Valencia ( Site 1718)

    Valencia, Valenciana, Comunitat, Spain 46026

    Recruiting now

  • Hospital Universitari Vall d'Hebron-Servei de Hematologia i Oncologia Pediatrica ( Site 1716)

    Barcelona, Spain 08035

    Recruiting now

  • Sahlgrenska Universitetssjukhuset ( Site 1634)

    Gothenburg, Västra Götaland County, Sweden 416 85

    Recruiting now

  • National Taiwan University Hospital ( Site 1983)

    Taipei, Taiwan 10002

    Recruiting now

  • Ege Universitesi Hastanesi ( Site 1963)

    Bornova, İzmir, Turkey (Türkiye) 35100

    Recruiting now

  • Hacettepe Universite Hastaneleri ( Site 1961)

    Ankara, Turkey (Türkiye) 06230

    Recruiting now

  • Ankara Bilkent Şehir Hastanesi ( Site 1962)

    Ankara, Turkey (Türkiye) 06800

    Recruiting now

  • Birmingham Children's Hospital-Oncology/Haematology ( Site 1349)

    Birmingham, England, United Kingdom B4 6NH

    Recruiting now

  • Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348)

    Newcastle upon Tyne, England, United Kingdom NE1 4PL

    Recruiting now

  • University College London Hospital ( Site 1350)

    London, London, City of, United Kingdom NW1 2PG

    Recruiting now

  • Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347)

    Sutton, Surrey, United Kingdom SM2 5PT

    Recruiting now

  • University Hospital of Wales ( Site 1346)

    Cardiff, United Kingdom CF14 4XW

    Recruiting now
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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

Inclusion Criteria:

* For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.
* For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.

Exclusion Criteria:

* History of solid organ transplant.
* Clinically significant (ie, active) cardiovascular disease.
* Known history of liver cirrhosis.
* Ongoing Grade \>1 peripheral neuropathy.
* Demyelinating form of Charcot-Marie-Tooth disease.
* Diagnosed with Down syndrome.
* Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.
* History of human immunodeficiency virus (HIV) infection.
* Contraindication or hypersensitivity to any of the study intervention components.
* Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.
* Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).
* Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Known additional malignancy that is progressing or has required active treatment within the past 1 year.
* Active infection requiring systemic therapy.
* Known history of Hepatitis B or known active Hepatitis C virus infection.
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Updated 2026-06-08 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.