RECRUITING

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

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Conditions

B-cell Acute Lymphoblastic LeukemiaDiffuse Large B-cell LymphomaBurkitt LymphomaNeuroblastomaEwing Sarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-16
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06395103

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.

Ages Eligible for Study:6 Months to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.
  1. * History of solid organ transplant.
  2. * Clinically significant (ie, active) cardiovascular disease.
  3. * Known history of liver cirrhosis.
  4. * Ongoing Grade \>1 peripheral neuropathy.
  5. * Demyelinating form of Charcot-Marie-Tooth disease.
  6. * Diagnosed with Down syndrome.
  7. * Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.
  8. * History of human immunodeficiency virus (HIV) infection.
  9. * Contraindication or hypersensitivity to any of the study intervention components.
  10. * Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.
  11. * 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).
  12. * 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
  13. * 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.
  14. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  15. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
  16. * Known additional malignancy that is progressing or has required active treatment within the past 1 year.
  17. * Active infection requiring systemic therapy.
  18. * Known history of Hepatitis B or known active Hepatitis C virus infection.
  19. * Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Contacts and Locations

Study Contact

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

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Yale-New Haven Hospital ( Site 1012)
New Haven, Connecticut, 06510
United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)
Iowa City, Iowa, 52242
United States
Rutgers Cancer Institute of New Jersey ( Site 1008)
New Brunswick, New Jersey, 08903
United States
New York Medical College ( Site 1023)
Valhalla, New York, 10595
United States
Children's Hospital of Philadelphia (CHOP) ( Site 1021)
Philadelphia, Pennsylvania, 19104
United States
Intermountain - Primary Children's Hospital ( Site 1014)
Salt Lake City, Utah, 84113
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-16
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2024-08-16
Study Completion Date2029-03-31

Terms related to this study

Additional Relevant MeSH Terms

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