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
ClinicalTrials ID:NCT06395103
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
| Parameter | Options |
|---|
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale-New Haven Hospital ( Site 1012) | 06510 | New Haven | Connecticut |
| Johns Hopkins All Children's Hospital ( Site 1025) | 33701 | Saint Petersburg | Florida |
| University of Iowa-Holden Comprehensive Cancer Center ( Site 1017) | 52242 | Iowa City | Iowa |
| Children's Mercy Hospital ( Site 1024) | 64108 | Kansas City | Missouri |
| Rutgers Cancer Institute of New Jersey ( Site 1008) | 08903 | New Brunswick | New Jersey |
| New York Medical College ( Site 1023) | 10595 | Valhalla | New York |
| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003) | 58122 | Fargo | North Dakota |
| Children's Hospital of Philadelphia (CHOP) ( Site 1021) | 19104 | Philadelphia | Pennsylvania |
| Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015) | 57105 | Sioux Falls | South Dakota |
| University of Texas MD Anderson Cancer Center ( Site 1007) | 77030 | Houston | Texas |
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