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Title
Status

 

MK-9999-01A/​LIGHTBEAM-U01 - LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

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MK-9999-01A/​LIGHTBEAM-U01 - LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

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DiagnosisB-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, Neuroblastoma, Ewing SarcomaStudy StatusOpen
PhaseI/II
Age6 Months to 25 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationBiological: Zilovertamab vedotin (IV) Other Names: MK-2140, VLS-101
Last Posted Update2025-08-26
ClinicalTrials.gov #NCT06395103
International Sponsor
Merck Sharp & Dohme LLC
Principal Investigators for Canadian Sites
Montreal Children's Hospital - Dr. Catherine Vézina
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

This study is part of a larger research project. The goal is to see if a new treatment called zilovertamab vedotin is safe and works well for children and young adults whose cancer has come back (relapsed) or did not get better with treatment (refractory).

The study is for patients with B-ALL (a type of leukemia that starts in the bone marrow and blood), DLBCL or Burkitt lymphoma (fast-growing blood cancers that affect the lymph nodes or organs), neuroblastoma (a cancer that starts in nerve cells, usually in young children), or Ewing sarcoma (a cancer of the bones or nearby tissue, often in children and teens).

Inclusion Criteria
  • Participant must have one of the following diagnoses:
    • Blood cancers: children with a type of leukemia called B-ALL and children with certain fast-growing lymphomas (DLBCL or Burkitt lymphoma) OR
    • Solid tumors: children with neuroblastoma or children with Ewing sarcoma

Other inclusion or exclusion criteria may apply and will be discussed with you by the study team.