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)
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Neoplasm Metastasis
In brief
This study is a rolling arm study of pembrolizumab in combination with investigational agents in pediatric participants with relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors with microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) or tumor mutational burden-high (TMB-H). This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2). Participants will be assigned to a treatment arm (either Part 1 or Part 2) that is open for enrollment. There will be no hypothesis testing in this study.
Key facts
- Study ID
- NCT06395090
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 0
- Starts
- 2025-01-15
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2025-04-08
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must have 1 of the following histologically or cytologically confirmed diagnosis of Relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors that are microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), or solid tumors that are tumor mutational burden-high (TMB-H)
- Must have recovered from all AEs from previous anticancer therapies
- Human immunodeficiency virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)
You may not qualify if…
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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