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Led by Merck Sharp & Dohme LLC · Updated on 2026-07-06
370
Participants Needed
16
Research Sites
N/A
Total Duration
Researchers are evaluating pembrolizumab, an immunotherapy, in children and teens with advanced melanoma, solid tumors, and lymphomas that are advanced, relapsed, or refractory. The study aims to determine if different doses of pembrolizumab can reduce or eliminate these cancers. Enrollment restrictions have been applied over time for certain age groups and tumor types. Participants receive pembrolizumab intravenously at a starting dose of 2 mgkg up to 200 mg every three weeks. Different groups include children with melanoma, solid tumors, relapsed refractory classical Hodgkin lymphoma, MSI-H solid tumors, TMB-H solid tumors, and high-risk resected melanoma. Enrollment for some groups has been closed with protocol amendments. Participants will be monitored for tumor response using established cancer criteria over up to two years. Researchers will assess objective response rates, duration of response, progression-free survival, adverse events, and drug tolerability. Safety and disease status are tracked during and after treatment, with study participation lasting until February 2028.
CONDITIONS
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
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Merck Sharp & Dohme LLC
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Pembrolizumab IV (trial) | Current practice for pediatric relapsed/refractory solid tumor or lymphoma |
|---|---|---|
| what it is | A single‑arm phase 1/2 study administering pembrolizumab by IV infusion to children with advanced, relapsed or refractory solid tumours or lymphomas | Typical salvage approach uses multi‑agent chemotherapy with or without stem cell transplant in relapsed or refractory pediatric solid tumours or lymphomas |
| role in trial | Participants receive pembrolizumab to assess safety, dose and antitumour activity | Not a trial arm; serves as external clinical context |
| primary use | Investigated as immunotherapy for children with refractory or relapsed malignancy | Used as rescue or salvage therapy when standard treatments have failed |
| how it is given or performed | Delivered as intravenous infusion every three weeks for up to 35 doses or until discontinuation | Administered as cycles of chemotherapy often combined with high‑dose chemotherapy and possible stem cell transplant |
| evidence status | Early data from KEYNOTE‑051 show manageable safety and signals of antitumour activity in relapsed/refractory Hodgkin lymphoma, with limited activity in other tumour types | Chemotherapy‑based salvage regimens and transplant are standard with known potential for durable remission in relapsed pediatric lymphoma or solid tumours |
| important risks | Immune‑related adverse events and infusion reactions may occur; safety being assessed in trial | Significant toxicity common, including chemotherapy‑related side effects and transplant complications |
| important limitations | Single‑arm design without comparator limits assessment of comparative benefit; activity varies by tumour type | High‑intensity treatments may not be feasible for all; long‑term side‑effects and variable responses |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive pembrolizumab intravenously every 3 weeks at a dose based on their weight. Different groups receive treatment depending on their cancer type and age. Enrollment for some groups has been closed based on protocol amendments.
Visits every 3 weeks for drug administration and monitoring
Duration - Up to 2 years
Participants are monitored for tumor response, disease progression, and safety outcomes using imaging and clinical assessments for up to 2 years after treatment starts.
Regular visits for assessments and safety monitoring
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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Birgit Geoerger, Hyoung Jin Kang, Michal Yalon-Oren...
https://pubmed.ncbi.nlm.nih.gov/31812554/Merck Sharp & Dohme LLC
Lead Sponsor
