A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
Condition(s) studied
Study 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, enrollment of participants with solid tumors and participants 6 months to under 12 years old with melanoma were closed.
With Amendment 13, enrollment was closed for participants with relapsed refractory classical Hodgkin lymphoma (rrCHL), microsatellite instabilty-high (MSI-H) solid tumors, tumor-mutational burden-high (TMB-H) solid tumors, and participants 12 years old to \<18 years old with advanced melanoma.
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors and Other Lymphoma Version 1.1 (RECIST 1.1) per Site Assessment (Each Disease Indication Evaluated Separately) — Up to 2 years
The ORR is assessed by RECIST 1.1 per site assessment. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. - ORR by RECIST 1.1 per Site Assessment for MSI-H or TMBH Solid Tumors (Each Cohort Evaluated Separately) — Up to 2 years
The ORR is assessed by RECIST 1.1 per site assessment. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. - ORR by International Working Group (IWG) Response Criteria (Cheson, 2007) per Blinded Independent Central Review (BICR) Assessment for rrcHL Cohort — Up to approximately 2 years
The ORR is assessed by blinded independent central review utilizing the International Working Group \[IWG\] response assessment criteria per Cheson 2007 by BICR. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Participants with missing data are considered non-responders. - Number of Participants with Dose-Limiting Toxicities (DLTs) — Cycle 1 (Up to 21 days)
Number of participants experiencing toxicities that are possibly, probably, or definitely related to study therapy; that meet pre-defined severity criteria; and result in a change in the given dose. - Number of Participants Experiencing Adverse Events (AEs) — Up to 27 months
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. - Number of Participants Discontinuing Study Drug Due to AEs — Up to 2 years
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Call for Information (Investigational Site 0019) | Aurora | Colorado | Recruiting |
| Call for Information (Investigational Site 0024) | Chicago | Illinois | Recruiting |
| Call for Information (Investigational Site 0026) | Boston | Massachusetts | Recruiting |
| Call for Information (Investigational Site 0031) | New York | New York | Recruiting |
| Call for Information (Investigational Site 0070) | Fargo | North Dakota | Recruiting |
| Call for Information (Investigational Site 0071) | Sioux Falls | South Dakota | Recruiting |
| Call for Information (Investigational Site 0054) | Dallas | Texas | Recruiting |
| MSD Brasil | São Paulo | Brazil | Recruiting |
| MSD France | Paris | France | Recruiting |
| MSD Sharp & Dohme GmbH | München | Germany | Recruiting |
| Merck Sharp & Dohme Co. Ltd. | Hod HaSharon | Israel | Recruiting |
| MSD Italia S.r.l. | Rome | Italy | Recruiting |
| Merck Sharp & Dohme Lda. | Paço de Arcos | Portugal | Recruiting |
| MSD Korea LTD | Seoul | South Korea | Recruiting |
| MSD Sweden | Stockholm | Sweden | Recruiting |
| Merck Sharp & Dohme Ltd. | London | United Kingdom | Recruiting |
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02332668 on ClinicalTrials.gov ↗ ← All trials in the USA