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

Description

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.

Conditions

B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, Neuroblastoma, Ewing Sarcoma

Study Overview

Study Details

Study 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.

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

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

Condition
B-cell Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale-New Haven Hospital ( Site 1012), New Haven, Connecticut, United States, 06510

Iowa City

University of Iowa-Holden Comprehensive Cancer Center ( Site 1017), Iowa City, Iowa, United States, 52242

New Brunswick

Rutgers Cancer Institute of New Jersey ( Site 1008), New Brunswick, New Jersey, United States, 08903

Valhalla

New York Medical College ( Site 1023), Valhalla, New York, United States, 10595

Philadelphia

Children's Hospital of Philadelphia (CHOP) ( Site 1021), Philadelphia, Pennsylvania, United States, 19104

Salt Lake City

Intermountain - Primary Children's Hospital ( Site 1014), Salt Lake City, Utah, United States, 84113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

6 Months to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-03-31