A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01)
NCT ID: NCT06395090
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2025-01-15
2029-06-30
Brief Summary
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There will be no hypothesis testing in this study.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Favezelimab + Pembrolizumab
Participants will receive pembrolizumab and favezelimab via an intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 cycles. Each cycle is 21 days.
Pembrolizumab
IV infusion
Favezelimab
IV infusion
Favezelimab/Pembrolizumab
Participants will receive coformulated favezelimab/pembrolizumab via an IV infusion Q3W for up to 35 cycles. Each cycle is 21 days.
Favezelimab/Pembrolizumab
IV infusion
Pembrolizumab + Vibostolimab
Participants will receive pembrolizumab and vibostolimab via an IV infusion Q3W for up to 35 cycles. Each cycle is 21 days.
Pembrolizumab
IV infusion
Vibostolimab
IV infusion
Pembrolizumab/Vibostolimab
Participants will receive coformulated pembrolizumab/vibostolimab via an IV infusion Q3W for up to 35 cycles. Each cycle is 21 days.
Pembrolizumab/Vibostolimab
IV infusion
Interventions
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Pembrolizumab
IV infusion
Favezelimab
IV infusion
Favezelimab/Pembrolizumab
IV infusion
Vibostolimab
IV infusion
Pembrolizumab/Vibostolimab
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have recovered from all AEs from previous anticancer therapies
* Human immunodeficiency virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Received prior anticancer therapy with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) in combination with either an Anti- lymphocyte-activation gene 3 (LAG-3) agent or an Anti- T-cell immunoreceptor with immunoglobulin (Ig) and ITIM domains (TIGIT) agent
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Known additional malignancy that is progressing or has required active treatment within the past 1 year
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Active infection requiring systemic therapy
* Concurrent active Hepatitis B and Hepatitis C virus infection
* History of allogenic tissue/solid organ transplant
* Has symptoms of or is being treated for graft versus host disease (GVHD)
* Has not adequately recovered from major surgery or have ongoing surgical complications
* Known tumors involving the brainstem
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Yale-New Haven Hospital ( Site 2012)
New Haven, Connecticut, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 2017)
Iowa City, Iowa, United States
Children's Mercy Hospital ( Site 2024)
Kansas City, Missouri, United States
Rutgers Cancer Institute of New Jersey ( Site 2008)
New Brunswick, New Jersey, United States
New York Medical College ( Site 2023)
Valhalla, New York, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2003)
Fargo, North Dakota, United States
Children's Hospital of Philadelphia (CHOP) ( Site 2021)
Philadelphia, Pennsylvania, United States
Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 2015)
Sioux Falls, South Dakota, United States
Intermountain - Primary Children's Hospital ( Site 2014)
Salt Lake City, Utah, United States
Seoul National University Hospital-Pediatrics ( Site 2972)
Seoul, , South Korea
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 2973)
Seoul, , South Korea
National Taiwan University Hospital ( Site 2983)
Taipei, , Taiwan
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-9999-01B
Identifier Type: OTHER
Identifier Source: secondary_id
LIGHTBEAM-U01
Identifier Type: OTHER
Identifier Source: secondary_id
2023-507179-23
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1295-3472
Identifier Type: REGISTRY
Identifier Source: secondary_id
9999-01B
Identifier Type: -
Identifier Source: org_study_id
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