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Looking for participantsPhase1/Phase2

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT02332668

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pembrolizumab (biological)
How long the study runs
Study runs about 155 months (dates as stated)
About the drug or intervention
Pembrolizumab — biological: IV infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing pembrolizumab (also called MK-3475) in children and young people aged 6 months to under 18 years who have an advanced solid tumour or lymphoma that cannot be cured and has not responded to standard treatment, or where no suitable standard treatment exists. Conditions include melanoma, classical Hodgkin lymphoma and other solid tumours. The study is sponsored by Merck Sharp & Dohme LLC.

Who can take part

  • Aged between 6 months and under 18 years when consent is signed
  • Have an advanced or spread solid tumour or lymphoma that cannot be cured, and standard treatment has failed, does not exist, or is not considered suitable
  • Any number of previous treatments is allowed
  • A tissue sample (stored or a new biopsy) must be available for testing
  • Have advanced melanoma, or a PD-L1-positive advanced, relapsed or refractory solid tumour or lymphoma (PD-L1 is a protein on cancer cells)
  • Have cancer that can be measured on scans, using standard scoring rules; children with neuroblastoma that is only visible on a special MIBG scan may also join
  • Be well enough day-to-day (a play or activity score of at least 50 out of 100), with organs working well enough
  • Not be pregnant or breastfeeding; those who can have children must use contraception or be abstinent during treatment and for at least 120 days after the last dose; men must follow local contraception rules

Who may not be able to

  • Currently in another study, or had an experimental drug or device within 4 weeks
  • Weakened immune system, or taking steroids or other medicines that suppress the immune system within 7 days
  • Cancer treatment within 2 weeks of starting, or still recovering from side effects of previous treatment
  • Radiotherapy within 2 weeks of starting
  • Another cancer that is growing or needing treatment (with some exceptions like certain skin cancers)
  • Cancer that has spread to the brain or the lining around the brain, or tumours involving the brain stem
  • Severe allergic reaction (Grade 3 or worse) to pembrolizumab or its ingredients
  • Active autoimmune disease needing treatment in the past 2 years (hormone replacement such as thyroxine or insulin is allowed)
  • Past lung inflammation (pneumonitis) that needed steroids, or current pneumonitis
  • An infection needing treatment when the study starts
  • Pregnant, breastfeeding, or planning to have a baby during the study or up to 120 days after the last dose
  • Previous treatment with drugs targeting the immune system, such as anti-PD-1, anti-PD-L1, anti-PD-L2, or similar T-cell targeting drugs (including CTLA-4, OX-40, CD137)
  • HIV infection
  • Hepatitis B or hepatitis C
  • History of active tuberculosis (TB)
  • Had a live vaccine within 30 days of starting the study medicine
  • Had a solid organ transplant at any time, or a stem cell transplant from a donor within the last 5 years (those over 5 years ago are allowed if there are no graft-versus-host disease symptoms)
  • Any other condition, treatment or test result that could affect the study results or stop full participation
  • Psychiatric or substance abuse problems that would interfere with taking part

What taking part involves

  • • Taking the study medicine pembrolizumab — details of dose and how it is given are not stated, so ask the trial team
  • • Providing a tissue sample for testing
  • • Regular scans and checks to measure the cancer and monitor health

Time commitment: Not stated — ask the trial team about how long the study lasts, how many hospital visits are needed, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
6 Months to 17 Years
Who
All
Number of participants
370
Started
2015-03-19
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for melanoma
  • • Phase1/Phase2 - 370 participants
  • • 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

Who can take part?

  • • Ages 6 Months to 17 Years
  • • Diagnosed with melanoma

Where?

  • • London - Merck Sharp & Dohme Ltd.

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

MelanomaLymphomaSolid TumorClassical Hodgkin LymphomaMicrosatellite-instability-high Solid Tumor

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 6 Months - 17 Years
  • Who can join: All genders

Biomarkers mentioned

PD-L1have a negativeCD137

Treatment history

Treatments you must have had:

  • ✓ regimens

What the study is looking for

  • ✓Between 6 months and \<18 years of age on day of signing agreement to take part is documented.
  • ✓Any number of prior treatment regimens
  • ✓Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a...
  • ✓Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
  • ✓cancer that can be measured on scans based on (standard scan measurements) (Or based on IWG \[Cheson, 2007\] \[i.e., measurement must be \>15 mm in...

Who cannot take part

  • ✗Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy...
  • ✗Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not...
  • ✗Prior radiotherapy within 2 weeks of start of study treatment
  • ✗Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • ✗Tumor(s) involving the brain stem
See the full criteria
Inclusion Criteria: * 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 Criteria: * 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

Where Is This Study? (1 UK site)

Merck Sharp & Dohme Ltd.

London, United Kingdom

Recruiting
Site contact (verified)
Natalie White44 (0) 208 154 8000

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07