Trial Title:
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
NCT ID:
NCT06395103
Condition:
B-cell Acute Lymphoblastic Leukemia
Diffuse Large B-cell Lymphoma
Burkitt Lymphoma
Neuroblastoma
Ewing Sarcoma
Conditions: Official terms:
Burkitt Lymphoma
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neuroblastoma
Hematologic Neoplasms
Sarcoma, Ewing
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Zilovertamab vedotin
Description:
Administered via IV infusion
Arm group label:
Zilovertamab vedotin
Other name:
MK-2140
Other name:
VLS-101
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.
Criteria for eligibility:
Criteria:
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 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.
Gender:
All
Minimum age:
6 Months
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale-New Haven Hospital ( Site 1012)
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
203-785-4640
Facility:
Name:
University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
319-356-7673
Facility:
Name:
New York Medical College ( Site 1023)
Address:
City:
Valhalla
Zip:
10595
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
914-614-4270
Facility:
Name:
Intermountain - Primary Children's Hospital ( Site 1014)
Address:
City:
Salt Lake City
Zip:
84113
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
801-662-4700
Facility:
Name:
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
Address:
City:
São José do Rio Preto
Zip:
15090000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+55 11 97412-1234
Facility:
Name:
Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674)
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
972506530208
Facility:
Name:
Sheba Medical Center ( Site 1675)
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
972526666361
Facility:
Name:
Seoul National University Hospital-Pediatrics ( Site 1972)
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82220723304
Facility:
Name:
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82230105994
Facility:
Name:
Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348)
Address:
City:
Newcastle upon Tyne
Zip:
NE1 4PL
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
07469172815
Facility:
Name:
University College London Hospital ( Site 1350)
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
07905 602570
Start date:
August 16, 2024
Completion date:
March 31, 2029
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06395103
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=9999-01A&kw=9999-01A
