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

Launched by MERCK SHARP & DOHME LLC · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial, called Substudy 01A, is investigating a new treatment called zilovertamab vedotin for children and young adults with certain types of blood cancers and solid tumors. Specifically, it is looking at its effectiveness and safety in patients with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia, diffuse large B-cell lymphoma, Burkitt lymphoma, neuroblastoma, and Ewing sarcoma. The trial is currently recruiting participants aged between 18 months and 31 years.

To participate, patients need to have a confirmed diagnosis of one of these cancers. However, there are some important criteria to consider. For example, patients who have had a solid organ transplant, certain heart conditions, or specific infections may not be eligible. If someone joins the trial, they can expect to receive close medical supervision and be part of a study that aims to improve treatment options for these serious conditions. It's important to discuss with a healthcare provider to see if this trial is the right fit for the patient.

Gender

ALL

Eligibility criteria

• 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.