LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors
Merck Sharp & Dohme LLC
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.
Eligibility
- Age range
- 0–25 years
- Sex
- All
- Healthy volunteers
- No
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 n…
Interventions
- BiologicalZilovertamab vedotin
Administered via IV infusion
Locations (67)
- Children's Hospital Los Angeles ( Site 1006)Los Angeles, California
- Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)Aurora, Colorado
- Yale New Haven Hospital ( Site 1012)New Haven, Connecticut
- Johns Hopkins All Children's Hospital ( Site 1025)St. Petersburg, Florida
- University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)Iowa City, Iowa
- Dana-Farber Cancer Institute ( Site 1013)Boston, Massachusetts