Actively Recruiting
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-13
90
Participants Needed
67
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.
CONDITIONS
Official Title
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization classification for hematologic malignancies
- Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma for solid tumor malignancies
You will not qualify if you...
- History of solid organ transplant
- 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 or receiving systemic treatment or prophylaxis for it
- History of HIV infection
- Contraindication or allergy to any study intervention components
- Prior radiotherapy within 4 weeks before starting study treatment without full recovery
- Ongoing chronic corticosteroid therapy above 10 mg prednisone equivalent daily or unstable dosing
- Recent use or expected need of strong CYP3A4 inhibitors or inducers around study treatment period
- Prior systemic anticancer therapy including investigational agents within 4 weeks before first dose (except certain low-dose therapies)
- Live or live-attenuated vaccine within 30 days before first dose (killed vaccines allowed)
- Use of investigational agent or device within 4 weeks before study treatment
- Additional progressing malignancy or requiring active treatment within past year
- Active infection requiring systemic therapy
- Known hepatitis B or active hepatitis C infection
- Not recovered from major surgery or with ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 67 locations
1
Children's Hospital Los Angeles ( Site 1006)
Los Angeles, California, United States, 90027
Actively Recruiting
2
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Yale New Haven Hospital ( Site 1012)
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Johns Hopkins All Children's Hospital ( Site 1025)
St. Petersburg, Florida, United States, 33701
Actively Recruiting
5
University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Dana-Farber Cancer Institute ( Site 1013)
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Corewell Health ( Site 1001)
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
8
Children's Mercy Hospital ( Site 1024)
Kansas City, Missouri, United States, 64108
Actively Recruiting
9
Rutgers Cancer Institute of New Jersey ( Site 1008)
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center ( Site 1010)
New York, New York, United States, 10065
Actively Recruiting
11
New York Medical College ( Site 1023)
Valhalla, New York, United States, 10595
Actively Recruiting
12
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)
Fargo, North Dakota, United States, 58102
Actively Recruiting
13
Oregon Health and Science University ( Site 1004)
Portland, Oregon, United States, 97239
Actively Recruiting
14
Children's Hospital of Philadelphia (CHOP) ( Site 1021)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
16
University of Texas MD Anderson Cancer Center ( Site 1007)
Houston, Texas, United States, 77030
Actively Recruiting
17
Intermountain - Primary Children's Hospital ( Site 1014)
Salt Lake City, Utah, United States, 84113
Actively Recruiting
18
Sydney Children's Hospital ( Site 1997)
Randwick, New South Wales, Australia, 2031
Actively Recruiting
19
Queensland Children's Hospital-Oncology & Haematology ( Site 1996)
Brisbane, Queensland, Australia, 4101
Actively Recruiting
20
UZ Gent ( Site 1428)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
21
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268)
Curitiba, Paraná, Brazil, 81520-060
Completed
22
Hospital de Clinicas de Porto Alegre ( Site 1265)
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
23
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264)
Barretos, São Paulo, Brazil, 14784400
Actively Recruiting
24
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
Actively Recruiting
25
McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
26
Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881)
Concepción, Biobio, Chile, 4070038
Actively Recruiting
27
Hospital Luis Calvo Mackenna ( Site 1879)
Santiago, Region M. de Santiago, Chile, 7500539
Actively Recruiting
28
Hospital Carlos Van Buren ( Site 1880)
Valparaíso, Valparaiso, Chile, 2341131
Actively Recruiting
29
Hospital Pablo Tobon Uribe ( Site 1923)
Medellín, Antioquia, Colombia, 050034
Actively Recruiting
30
Clinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924)
Barranquilla, Atlántico, Colombia, 080020
Actively Recruiting
31
IMAT S.A.S ( Site 1921)
Montería, Departamento de Córdoba, Colombia, 230002
Actively Recruiting
32
Detska nemocnice FN Brno ( Site 1388)
Brno, Brno-mesto, Czechia, 613 00
Actively Recruiting
33
Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 1387)
Prague, Praha 5, Czechia, 150 00
Actively Recruiting
34
Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 1467)
Copenhagen, Capital Region, Denmark, DK-2100
Actively Recruiting
35
CHU de Bordeaux. Hopital Pellegrin ( Site 1105)
Bordeaux, Aquitaine, France, 33076
Actively Recruiting
36
CENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100)
Lyon, Auvergne-Rhône-Alpes, France, 69373
Actively Recruiting
37
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1104)
Nantes, Loire-Atlantique, France, 44093
Actively Recruiting
38
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1102)
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
Actively Recruiting
39
Gustave Roussy ( Site 1103)
Villejuif, Île-de-France Region, France, 94805
Actively Recruiting
40
Universitaetsklinikum Tuebingen ( Site 1142)
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
41
Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 1145)
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
42
Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Site 1141)
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
43
Charité Campus Virchow-Klinikum-Klinik für Pädiatrie mit Schwerpunkt Hämatologie und Onkologie ( Site 1143)
Berlin, Germany, 13353
Actively Recruiting
44
Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 1797)
Athens, Attica, Greece, 115 27
Actively Recruiting
45
Semmelweis Egyetem ( Site 1838)
Budapest, Hungary, 1085
Actively Recruiting
46
Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)
Haifa, Israel, 3109601
Actively Recruiting
47
Sheba Medical Center ( Site 1675)
Ramat Gan, Israel, 5265601
Actively Recruiting
48
Fondazione IRCCS Istituto Nazionale dei Tumori-Pediatric Oncology ( Site 1552)
Milan, Lombardy, Italy, 20133
Actively Recruiting
49
Ospedale Pediatrico Bambino Gesù IRCCS-Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica ( Site 1553)
Rome, Roma, Italy, 00165
Actively Recruiting
50
Ospedale Infantile Regina Margherita-S.C. Oncoematologia Pediatrica ( Site 1551)
Torino, Italy, 10126
Actively Recruiting
51
Prinses Maxima Centrum voor Kinderoncologie ( Site 1510)
Utrecht, Netherlands, 3584 CS
Actively Recruiting
52
Narodny ustav detskych chorob ( Site 1592)
Bratislava, Bratislava Region, Slovakia, 831 01
Actively Recruiting
53
Seoul National University Hospital-Pediatrics ( Site 1972)
Seoul, South Korea, 03080
Actively Recruiting
54
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)
Seoul, South Korea, 05505
Actively Recruiting
55
Hospital Sant Joan de Déu-Pediatric Oncology Department ( Site 1717)
Esplugas de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
56
Hospital Infantil Universitario Niño Jesús-Servicio de Onco-Hematología Pediátrica ( Site 1715)
Madrid, Madrid, Comunidad de, Spain, 28009
Actively Recruiting
57
Hospital Universitari Vall d'Hebron-Servei de Hematologia i Oncologia Pediatrica ( Site 1716)
Barcelona, Spain, 08035
Actively Recruiting
58
Sahlgrenska Universitetssjukhuset ( Site 1634)
Gothenburg, Västra Götaland County, Sweden, 416 85
Actively Recruiting
59
National Taiwan University Hospital ( Site 1983)
Taipei, Taiwan, 10002
Actively Recruiting
60
Ege Universitesi Hastanesi ( Site 1963)
Bornova, İzmir, Turkey (Türkiye), 35100
Actively Recruiting
61
Hacettepe Universite Hastaneleri ( Site 1961)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
62
Ankara Bilkent Şehir Hastanesi ( Site 1962)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
63
Birmingham Children's Hospital-Oncology/Haematology ( Site 1349)
Birmingham, England, United Kingdom, B4 6NH
Actively Recruiting
64
Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348)
Newcastle upon Tyne, England, United Kingdom, NE1 4PL
Actively Recruiting
65
University College London Hospital ( Site 1350)
London, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
66
Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347)
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
67
University Hospital of Wales ( Site 1346)
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here