Actively Recruiting
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-05
370
Participants Needed
17
Research Sites
671 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Between 6 months and under 18 years of age on day of informed consent
- Diagnosed with locally advanced or metastatic solid tumor or lymphoma that is incurable or has failed prior standard therapy
- 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 for lymphoma
- Neuroblastoma patients with MIBG-positive evaluable disease may be enrolled
- Lansky Play Scale score of 50 or higher (for ages 6 months to 16 years) or Karnofsky score 50 or higher (for over 16 years)
- Adequate organ function
- Female participants of childbearing potential must have negative pregnancy test within 72 hours before first dose
- Female participants must be abstinent or use contraception during and for 120 days after study
- Male participants must use contraception according to local regulations
- Demonstrate adequate organ function
You will not qualify if you...
- Participated in another investigational study or used investigational therapy within 4 weeks prior to enrollment
- Diagnosis of immunodeficiency or receiving systemic steroids/immunosuppressive therapy within 7 days prior to enrollment
- Received systemic anti-cancer therapy within 2 weeks prior to study day 1 or not recovered from prior adverse events
- Received radiotherapy within 2 weeks prior to study treatment
- Known additional malignancy requiring active treatment except certain skin or in situ cancers
- Active central nervous system metastases or carcinomatous meningitis
- Tumors involving the 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 to conceive or father children during and 120 days after study
- Prior therapy with PD-1, PD-L1, PD-L2 agents or other T-cell receptor agents
- HIV infection
- Hepatitis B or C infection
- Active tuberculosis history
- Received live vaccine within 30 days prior to study
- Prior solid organ transplant or recent allogeneic hematopoietic stem cell transplant within 5 years
- Any condition or therapy that may interfere with study participation
- Psychiatric or substance abuse disorders interfering with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 0026)
Boston, Massachusetts, United States, 02445
Actively Recruiting
3
Call for Information (Investigational Site 0031)
New York, New York, United States, 10032
Actively Recruiting
4
Call for Information (Investigational Site 0070)
Fargo, North Dakota, United States, 58102
Actively Recruiting
5
Call for Information (Investigational Site 0032)
Cincinnati, Ohio, United States, 45229
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
Research Team
T
Toll Free Number
CONTACT
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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