Actively Recruiting

Phase 1
Phase 2
Age: 6Months - 17Years
All Genders
ID02332668

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)

Led by Merck Sharp & Dohme LLC · Updated on 2026-06-01

370

Participants Needed

17

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying children with advanced, relapsed, or refractory melanoma, solid tumors, and lymphomas. The trial aims to learn if different doses of pembrolizumab, an immunotherapy that helps the immune system fight cancer, can shrink or eliminate these cancers. Some groups of children are no longer enrolling due to amendments during the study. Participants receive pembrolizumab through an intravenous (IV) infusion every three weeks. The study includes different groups based on the type of cancer and age, such as melanoma, solid tumors, relapsed refractory classical Hodgkin lymphoma, and certain high-risk melanoma stages. Enrollment for some groups has closed over time as the study progressed. During the study, participants will have their cancer measured using established criteria and monitored for side effects and responses for up to two years. Researchers will assess tumor response, progression-free survival, overall survival, and duration of response. Safety is tracked through adverse event reporting and dose-limiting toxicity monitoring. The trial may last up to about two years per participant.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Months - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 6 months and under 18 years of age at consent
  • Diagnosed with histologically or cytologically confirmed locally advanced or metastatic solid malignancy or lymphoma that is incurable and failed prior standard therapy, or no standard therapy exists or is appropriate
  • Any number of prior treatment regimens allowed
  • Availability of tissue or lymph node biopsy sample
  • Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
  • Measurable disease based on RECIST 1.1 or IWG criteria
  • Participants with neuroblastoma with only MIBG-positive evaluable disease may enroll
  • Lansky Play Scale score of 50 or higher for ages 6 months to 16 years; Karnofsky score 50 or higher for over 16 years
  • Adequate organ function
  • Female participants of childbearing potential must have a negative pregnancy test before treatment
  • Female participants must be abstinent or use contraception during and for 120 days after treatment
  • Male participants must use contraception according to local regulations
  • Demonstrate adequate organ function
Not Eligible

You will not qualify if you...

  • Currently participating in another investigational study or received investigational therapy within 4 weeks
  • Diagnosis of immunodeficiency or receiving systemic immunosuppressive therapy within 7 days prior to allocation
  • Received prior systemic anti-cancer therapy within 2 weeks before study start or not recovered from previous treatment side effects
  • Received radiotherapy within 2 weeks prior to study treatment
  • Known additional progressing malignancy requiring active treatment except certain skin or cervical cancers
  • Active central nervous system metastases or carcinomatous meningitis
  • Tumor involving brain stem
  • Severe hypersensitivity to pembrolizumab or its components
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History of pneumonitis requiring steroids or current pneumonitis
  • Active infection requiring systemic therapy
  • Pregnant, breastfeeding, or planning pregnancy within study duration plus 120 days
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
  • HIV infection
  • Hepatitis B or C infection
  • Active tuberculosis
  • Received live vaccine within 30 days before study medication
  • History of solid organ transplant or recent allogeneic stem cell transplant within 5 years
  • Conditions or therapies that may interfere with study participation
  • Known psychiatric or substance abuse disorders interfering with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 2 years

Participants receive pembrolizumab as an intravenous infusion once every 3 weeks. This treatment is given to children with advanced melanoma or PD-L1 positive advanced, relapsed, or refractory solid tumors or lymphomas.

Infusions every 3 weeks

Follow-up

Duration - Up to approximately 2 years

Participants are monitored for treatment response, side effects, and overall survival following the treatment period.

Visits scheduled according to study follow-up assessments

Trial Site Locations

Total: 17 locations

1

Call for Information (Investigational Site 0019)

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Call for Information (Investigational Site 0024)

Chicago, Illinois, United States, 60637

Actively Recruiting

3

Call for Information (Investigational Site 0026)

Boston, Massachusetts, United States, 02445

Actively Recruiting

4

Call for Information (Investigational Site 0031)

New York, New York, United States, 10032

Actively Recruiting

5

Call for Information (Investigational Site 0070)

Fargo, North Dakota, United States, 58102

Actively Recruiting

6

Call for Information (Investigational Site 0071)

Sioux Falls, South Dakota, United States, 57117

Actively Recruiting

7

Call for Information (Investigational Site 0054)

Dallas, Texas, United States, 75235

Actively Recruiting

8

MSD Brasil

São Paulo, Brazil

Actively Recruiting

9

MSD France

Paris, France

Actively Recruiting

10

MSD Sharp & Dohme GmbH

München, Germany

Actively Recruiting

11

Merck Sharp & Dohme Co. Ltd.

Hod HaSharon, Israel

Actively Recruiting

12

MSD Italia S.r.l.

Rome, Italy

Actively Recruiting

13

Merck Sharp & Dohme BV

Haarlem, Netherlands

Actively Recruiting

14

Merck Sharp & Dohme Lda.

Paço de Arcos, Portugal

Actively Recruiting

15

MSD Korea LTD

Seoul, South Korea, 4130

Actively Recruiting

16

MSD Sweden

Stockholm, Sweden

Actively Recruiting

17

Merck Sharp & Dohme Ltd.

London, United Kingdom

Actively Recruiting

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Research Team

T

Toll Free Number

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

6

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Published Research Related To This Trial

Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial.

Birgit Geoerger, Hyoung Jin Kang, Michal Yalon-Oren...

https://pubmed.ncbi.nlm.nih.gov/31812554