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A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat children with different types of melanoma (skin cancer), solid tumors, and lymphomas (blood cancers) that are any of these: * Advanced, which means cancer spread in the body or cannot be removed with surgery * Relapsed, which means cancer has come back after it had responded to previous treatment (responded means it stopped growing, gets smaller, or disappeared) * Refractory, which means cancer did not respond to previous treatment Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Researchers want to learn if different doses of pembrolizumab can cause at least 1 of the types of cancer to get smaller or go away. With Amendment 8, enrolment of participants with solid tumours and participants 6 months to under 12 years old with melanoma were closed. Enrolment of participants 12-18 years old with melanoma continues. Enrolment of participants who have tumours with specific traits (microsatellite-instability-high (MSI-H), and tumour-mutational burden-high ≥10 mutation/Mb (TMB-H)) also continues.
Official title: A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)
Key Details
Gender
All
Age Range
6 Months - 17 Years
Study Type
INTERVENTIONAL
Enrollment
370
Start Date
2015-03-18
Completion Date
2027-10-25
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
IV infusion
Locations (17)
Call for Information (Investigational Site 0019)
Aurora, Colorado, United States
Call for Information (Investigational Site 0026)
Boston, Massachusetts, United States
Call for Information (Investigational Site 0031)
New York, New York, United States
Call for Information (Investigational Site 0070)
Fargo, North Dakota, United States
Call for Information (Investigational Site 0032)
Cincinnati, Ohio, United States
Call for Information (Investigational Site 0071)
Sioux Falls, South Dakota, United States
Call for Information (Investigational Site 0054)
Dallas, Texas, United States
MSD Brasil
São Paulo, Brazil
MSD France
Paris, France
MSD Sharp & Dohme GmbH
München, Germany
Merck Sharp & Dohme Co. Ltd.
Hod HaSharon, Israel
MSD Italia S.r.l.
Rome, Italy
Merck Sharp & Dohme BV
Haarlem, Netherlands
Merck Sharp & Dohme Lda.
Paço de Arcos, Portugal
MSD Korea LTD
Seoul, South Korea
MSD Sweden
Stockholm, Sweden
Merck Sharp & Dohme Ltd.
London, United Kingdom