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

Purpose

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

Eligibility

Eligible Ages
Between 6 Months and 25 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Zilovertamab vedotin 		Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).
  • Biological: Zilovertamab vedotin
    Administered via IV infusion
    Other names:
    • MK-2140
    • VLS-101

Recruiting Locations

Children's Hospital Los Angeles ( Site 1006)
Los Angeles, California 90027
Contact:
Study Coordinator
323-361-2121

Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)
Aurora, Colorado 80045
Contact:
Study Coordinator
720-777-1234

Yale New Haven Hospital ( Site 1012)
New Haven, Connecticut 06510
Contact:
Study Coordinator
203-785-4640

Johns Hopkins All Children's Hospital ( Site 1025)
St. Petersburg, Florida 33701
Contact:
Study Coordinator
727-767-4176

University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)
Iowa City, Iowa 52242
Contact:
Study Coordinator
319-356-2296

Dana-Farber Cancer Institute ( Site 1013)
Boston, Massachusetts 02215
Contact:
Study Coordinator
617-632-4580

Corewell Health ( Site 1001)
Grand Rapids, Michigan 49503
Contact:
Study Coordinator
616-486-0746

Children's Mercy Hospital ( Site 1024)
Kansas City, Missouri 64108
Contact:
Study Coordinator
816-302-6808

Rutgers Cancer Institute of New Jersey ( Site 1008)
New Brunswick, New Jersey 08903
Contact:
Study Coordinator
732-235-2465

Memorial Sloan Kettering Cancer Center ( Site 1010)
New York, New York 10065
Contact:
Study Coordinator
888-492-8401

New York Medical College ( Site 1023)
Valhalla, New York 10595
Contact:
Study Coordinator
914-614-4270

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)
Fargo, North Dakota 58102
Contact:
Study Coordinator
701-234-2000

Oregon Health and Science University ( Site 1004)
Portland, Oregon 97239
Contact:
Study Coordinator
503-494-8311

Children's Hospital of Philadelphia (CHOP) ( Site 1021)
Philadelphia, Pennsylvania 19104
Contact:
Study Coordinator
267-425-5544

Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)
Sioux Falls, South Dakota 57105
Contact:
Study Coordinator
605-312-1000

University of Texas MD Anderson Cancer Center ( Site 1007)
Houston, Texas 77030
Contact:
Study Coordinator
713-792-5410

Intermountain - Primary Children's Hospital ( Site 1014)
Salt Lake City, Utah 84113
Contact:
Study Coordinator
801-662-4700

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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