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

Last updated: July 4, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Neuroblastoma

Lymphoma

Treatment

Pembrolizumab

Clinical Study ID

NCT02332668
3475-051
2022-501257-36
MK-3475-051
U1111-1275-9516
2014-002950-38
2022-501257-36-00
  • Ages 6-17
  • All Genders

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, 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 Criteria

Inclusion

Inclusion Criteria:

  • Between 6 months and <18 years of age on day of signing informed consent isdocumented.

  • Histologically- or cytologically-documented, locally-advanced, or metastatic solidmalignancy or lymphoma that is incurable and has failed prior standard therapy, orfor which no standard therapy exists, or for which no standard therapy is consideredappropriate

  • Any number of prior treatment regimens

  • Tissue (or lymph node biopsy for rrcHL participants) available from an archivaltissue sample or, if appropriate, a newly obtained core or excisional biopsy of atumor lesion not previously irradiated

  • Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor orlymphoma

  • 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 rrcHLparticipants)

  • Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positiveevaluable disease may be enrolled

  • Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years ofage; or Karnofsky score ≥50 for participants >16 years of age

  • Adequate organ function

  • Female participants of childbearing potential should have a negative urine or serumpregnancy test within 72 hours before the first dose of study medication

  • Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBPwho is abstinent from heterosexual intercourse or using contraception during theintervention period and for at least 120 days after the last dose of studyintervention

  • Contraceptive use by men should be consistent with local regulations regarding themethods of contraception for those participating in clinical studies.

  • Demonstrate adequate organ function.

Exclusion

Exclusion Criteria:

  • Currently participating and receiving study therapy in, or has participated in astudy of an investigational agent and received study therapy or used aninvestigational device within 4 weeks of the date of allocation/randomization

  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any otherform of immunosuppressive therapy within 7 days prior to the date ofallocation/randomization

  • Prior systemic anti-cancer therapy including investigational agent within 2 weeksprior to study Day 1 or not recovered from adverse events due to a previouslyadministered agent

  • Prior radiotherapy within 2 weeks of start of study treatment

  • Known additional malignancy that is progressing or requires active treatment withthe exception of basal cell carcinoma of the skin, squamous cell carcinoma of theskin or carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) withpotentially 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 corticosteroidreplacement therapy for adrenal or pituitary insufficiency) is acceptable

  • Has a history of (non-infectious) pneumonitis that required steroids or currentpneumonitis.

  • Active infection requiring systemic therapy

  • Pregnant or breastfeeding, or expecting to conceive or father children within theprojected duration of the trial through 120 days after the last dose of studymedication

  • 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 orinhibitory 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 hematopoieticstem cell transplantation within the last 5 years. (Participants who have had anallogeneic hematopoietic transplant >5 years ago are eligible as long as there areno symptoms of Graft Versus Host Disease [GVHD].)

  • History or current evidence of any condition, therapy, or laboratory abnormality, orknown severe hypersensitivity to any component or analog of the trial treatment,that might confound the results of the trial, or interfere with the participant'sparticipation for the full duration of the study

  • Known psychiatric or substance abuse disorders that would interfere with therequirements of the study

Study Design

Total Participants: 370
Treatment Group(s): 1
Primary Treatment: Pembrolizumab
Phase: 1/2
Study Start date:
March 18, 2015
Estimated Completion Date:
October 25, 2027

Connect with a study center

  • MSD Australia

    North Ryde,
    Australia

    Site Not Available

  • Merck Sharp & Dohme

    North Ryde,
    Australia

    Active - Recruiting

  • MSD Brasil

    Sao Paulo,
    Brazil

    Active - Recruiting

  • Merck Canada

    Kirkland, Quebec H9H 3L1
    Canada

    Site Not Available

  • MSD France

    Paris,
    France

    Active - Recruiting

  • MSD Sharp & Dohme GmbH

    Haar,
    Germany

    Site Not Available

  • MSD Sharp & Dohme GmbH

    München,
    Germany

    Active - Recruiting

  • Merck Sharp & Dohme Co. Ltd.

    Hod Hasharon,
    Israel

    Active - Recruiting

  • MSD Italia S.r.l.

    Rome,
    Italy

    Active - Recruiting

  • MSD Korea LTD

    Seoul, 4130
    Korea, Republic of

    Active - Recruiting

  • Merck Sharp & Dohme BV

    Haarlem,
    Netherlands

    Active - Recruiting

  • Merck Sharp & Dohme (New Zealand) Ltd.,

    Auckland,
    New Zealand

    Site Not Available

  • Merck Sharp & Dohme (New Zealand) Ltd.

    Wellington,
    New Zealand

    Site Not Available

  • Merck Sharp & Dohme Lda.

    Paco D'arcos,
    Portugal

    Active - Recruiting

  • MSD Sweden

    Stockholm,
    Sweden

    Active - Recruiting

  • Merck Sharp & Dohme Ltd.

    Hoddesdon,
    United Kingdom

    Site Not Available

  • Merck Sharp & Dohme Ltd.

    London,
    United Kingdom

    Active - Recruiting

  • Call for Information (Investigational Site 0068)

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Call for Information (Investigational Site 0060)

    Loma Linda, California 92354
    United States

    Site Not Available

  • Call for Information (Investigational Site 0050)

    Los Angeles, California 90027
    United States

    Site Not Available

  • Call for Information (Investigational Site 0058)

    Madera, California 93636
    United States

    Site Not Available

  • Call for Information (Investigational Site 0059)

    Orange, California 92868
    United States

    Site Not Available

  • Call for Information (Investigational Site 0017)

    San Diego, California 92123
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    San Francisco, California 94158
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    Aurora, Colorado 80045
    United States

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  • Call for Information (Investigational Site 0020)

    New Haven, Connecticut 06511
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    Washington, District of Columbia 20010
    United States

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    Washington, D.C., District of Columbia 20010
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  • Call for Information (Investigational Site 0065)

    Atlanta, Georgia 30322
    United States

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    Chicago, Illinois 60611
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  • Call for Information (Investigational Site 0025)

    Indianapolis, Indiana 46202
    United States

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    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Call for Information (Investigational Site 0026)

    Boston, Massachusetts 02445
    United States

    Active - Recruiting

  • Call for Information (Investigational Site 0027)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Call for Information (Investigational Site 0052)

    Minneapolis, Minnesota 55454
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  • Call for Information (Investigational Site 0057)

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Call for Information (Investigational Site 0029)

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Call for Information (Investigational Site 0029)

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Call for Information (Investigational Site 0031)

    New York, New York 10032
    United States

    Active - Recruiting

  • Call for Information (Investigational Site 0070)

    Fargo, North Dakota 58122
    United States

    Active - Recruiting

  • Call for Information (Investigational Site 0032)

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Call for Information (Investigational Site 0033)

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Call for Information (Investigational Site 0053)

    Columbus, Ohio 43017
    United States

    Site Not Available

  • Call for Information (Investigational Site 0013)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Call for Information (Investigational Site 0034)

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Call for Information (Investigational Site 0071)

    Sioux Falls, South Dakota 57117
    United States

    Active - Recruiting

  • Call for Information (Investigational Site 0012)

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • Call for Information (Investigational Site 0035)

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Call for Information (Investigational Site 0054)

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Call for Information (Investigational Site 0069)

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Call for Information (Investigational Site 0036)

    Houston, Texas 77030
    United States

    Site Not Available

  • Call for Information (Investigational Site 0056)

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Call for Information (Investigational Site 0014)

    Seattle, Washington 98105
    United States

    Site Not Available

  • Call for Information (Investigational Site 0055)

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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