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Pembrolizumab for Advanced Solid Tumors or Lymphoma in Children

This study is testing a medicine called pembrolizumab in children aged 6 months to 17 years who have advanced melanoma (skin cancer), solid tumors, or lymphomas (blood cancers). These cancers are either advanced (spread), relapsed (came back), or refractory (didn't respond to previous treatment). Pembrolizumab is an immunotherapy, which helps your body's immune system fight cancer. Researchers want to see if different doses of pembrolizumab can shrink or get rid of these cancers. The study aims to measure how many participants see their cancer shrink or disappear within about two years.

Study design
This is an interventional study planning to enroll up to 370 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately two years to see how their cancer responds to treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02332668

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

Recruiting
PHASE1Ages 6–17InterventionalTreatment
Merck Sharp & Dohme LLC
~370 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Pembrolizumab

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Up to 2 years
+5 more outcomes measured

Conditions

Melanoma
Lymphoma
Solid Tumor
Classical Hodgkin Lymphoma
Microsatellite-instability-high Solid Tumor

Explore related trials

Classic Hodgkin LymphomaLymphomaMelanomaSolid NeoplasmMSI1 Gene

Where it's being run

16 sites across 16 states
Colorado1
Illinois1
Massachusetts1
New York1
North Dakota1
South Dakota1
Texas1
Brazil1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Between 6 months and \<18 years of age on day of signing informed consent is documented.
Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate
Any number of prior treatment regimens
Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
Measurable disease based on RECIST 1.1 (Or based on IWG \[Cheson, 2007\] \[i.e., measurement must be \>15 mm in longest diameter or \>10 mm in short axis\] for rrcHL participants)
Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years of age; or Karnofsky score ≥50 for participants \>16 years of age
Adequate organ function
Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours before the first dose of study medication
Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who is abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of study intervention
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Demonstrate adequate organ function.

Exclusion

Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation/randomization
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the date of allocation/randomization
Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
Prior radiotherapy within 2 weeks of start of study treatment
Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) with potentially curative therapy, or in situ cervical cancer
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Tumor(s) involving the brain stem
Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Active infection requiring systemic therapy
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of study medication
Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2 agent, or any agent directed to another stimulatory or inhibitory T-cell receptor (eg, cytotoxic lymphocyte associated protein-4 \[CTLA-4\], OX-40, CD137)
Human immunodeficiency virus (HIV)
Hepatitis B or C
Known history of active tuberculosis (TB; Bacillus tuberculosis)
Received a live vaccine within 30 days of planned start of study medication
Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had an allogeneic hematopoietic transplant \>5 years ago are eligible as long as there are no symptoms of Graft Versus Host Disease \[GVHD\].)
History or current evidence of any condition, therapy, or laboratory abnormality, or known severe hypersensitivity to any component or analog of the trial treatment, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study
Known psychiatric or substance abuse disorders that would interfere with the requirements of the study

What this trial measures

  • 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 CohortUp 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 AEsUp 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.