Health Trials

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

ConditionsB-cell Acute Lymphoblastic LeukemiaDiffuse Large B-cell LymphomaBurkitt LymphomaNeuroblastomaEwing Sarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-25
SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

History of solid organ transplant.

Clinically significant (ie, active) cardiovascular disease.

Trial design

Treatments tested in this trial

  • Zilovertamab vedotin

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov