RecruitingPhase 1/2

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

United States, Australia, Belgium90 participantsStarted 2024-08-16

Plain-language summary

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.

Who can participate

Age range

6 Months – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 CYP3…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)

Timeframe: Up to 42 days

Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs)

Timeframe: Up to approximately 54 months

Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs

Timeframe: Up to approximately 54 months

Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs

Timeframe: Up to approximately 54 months

Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Timeframe: Up to approximately 54 months

Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma

Timeframe: Up to approximately 54 months

Trial details

NCT IDNCT06395103

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-03-31

Contact for this trial

Toll Free Number

1-888-577-8839 Trialsites@msd.com

View on ClinicalTrials.gov More B-cell Acute Lymphoblastic Leukemia trials

Plain-language summary

Who can participate

Age range

6 Months – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)

Timeframe: Up to 42 days

Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs)

Timeframe: Up to approximately 54 months

Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs

Timeframe: Up to approximately 54 months

Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs

Timeframe: Up to approximately 54 months

Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Timeframe: Up to approximately 54 months

Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma

Timeframe: Up to approximately 54 months