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

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06395103

Patient View

This study evaluates the efficacy and safety of zilovertamab vedotin, administered via IV infusion, in pediatric patients with relapsed or refractory B-ALL, DLBCL/Burkitt lymphoma, neuroblastoma, and in pediatric and young adult patients with Ewing sarcoma. Eligibility requires a confirmed diagnosis per WHO classification for hematologic malignancies or histological confirmation for solid tumors.

Patient Parameters

Program Overview

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

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.

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