Clinical Trials Directory

Trials / Recruiting

RecruitingNCT02332668

A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)

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)

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
370 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Sex
All
Age
6 Months – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPembrolizumabIV infusion

Timeline

Start date
2015-03-18
Primary completion
2027-10-25
Completion
2027-10-25
First posted
2015-01-07
Last updated
2026-03-16

Locations

17 sites across 11 countries: United States, Brazil, France, Germany, Israel, Italy, Netherlands, Portugal, South Korea, Sweden, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT02332668. Inclusion in this directory is not an endorsement.