RecruitingPhase 1Phase 2NCT02332668

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)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

370 participants

Start Date

Mar 18, 2015

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 MonthsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether pembrolizumab — an immunotherapy drug that helps the immune system fight cancer — is safe and effective for children and teenagers with advanced solid tumors or lymphoma that have not responded to standard treatments. **You may be eligible if...** - You are between 6 months and under 18 years old - You have been confirmed to have an advanced solid tumor or lymphoma that cannot be cured - Your cancer has not responded to or has run out of standard treatment options - You are able to provide a tumor tissue sample for testing - Your general health and organ function meet required levels **You may NOT be eligible if...** - You have an active autoimmune disease - You are currently on immunosuppressive medications - You have had prior therapy with pembrolizumab or similar checkpoint inhibitor drugs - You have active brain metastases (cancer spread to the brain) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPembrolizumab

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

View Full Details on ClinicalTrials.gov

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NCT02332668


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