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

What this study is about

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 join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Children's Hospital Los Angeles ( Site 1006), Los Angeles, California, United States
• Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016), Aurora, Colorado, United States
• Yale New Haven Hospital ( Site 1012), New Haven, Connecticut, United States
• Johns Hopkins All Children's Hospital ( Site 1025), St. Petersburg, Florida, United States
• University of Iowa-Holden Comprehensive Cancer Center ( Site 1017), Iowa City, Iowa, United States
• Dana-Farber Cancer Institute ( Site 1013), Boston, Massachusetts, United States
• Corewell Health ( Site 1001), Grand Rapids, Michigan, United States
• Children's Mercy Hospital ( Site 1024), Kansas City, Missouri, United States
• Rutgers Cancer Institute of New Jersey ( Site 1008), New Brunswick, New Jersey, United States
• Memorial Sloan Kettering Cancer Center ( Site 1010), New York, New York, United States
• New York Medical College ( Site 1023), Valhalla, New York, United States
• Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003), Fargo, North Dakota, United States

+ 58 more sites.

Who to contact

Toll Free Number · 1-888-577-8839 · Trialsites@msd.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06395103.