Actively Recruiting
A Phase III 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
Eligibility Criteria
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
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
Research Team
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