Actively Recruiting
A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21/KEYNOTE-G21)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-28
20
Participants Needed
3
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are looking for new ways to treat people with solid tumors, lymphomas (blood cancers), and a certain type of skin cancer. The goals of this study are to learn: * About the safety of pembrolizumab (the study medicine) and if people tolerate it * What happens to different doses of pembrolizumab in a person's body over time * How the cancer responds (gets smaller or goes away) to treatment
CONDITIONS
Official Title
A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21/KEYNOTE-G21)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For participants with relapsed or refractory classical Hodgkin lymphoma (cHL) or primary mediastinal large B-cell lymphoma (PMBCL): confirmed diagnosis after most recent therapy and measurable disease per Lugano classification
- For participants with completely resected melanoma: surgically removed and confirmed Stage IIB, IIC, III, or IV cutaneous melanoma with no prior systemic therapy beyond surgery and all suspicious lesions confirmed negative
- For participants with locally advanced or metastatic melanoma: confirmed diagnosis of unresectable Stage III or Stage IV melanoma with measurable lesions per RECIST 1.1
- For participants with MSI-H/dMMR solid tumors: documented locally advanced or metastatic solid tumor that is incurable, failed prior therapy or no standard therapy exists, positive MSI-H or dMMR test, and measurable disease per RECIST 1.1
- For participants with TMB-H solid tumors: documented locally advanced or metastatic solid tumor that is incurable, failed prior therapy or no standard therapy exists, and measurable disease per RECIST 1.1
- For participants with Merkel cell carcinoma (MCC): confirmed locoregional recurrent or metastatic MCC not amenable to local therapy with measurable disease per RECIST 1.1
- For Arm 2 participants with MCC: untreated advanced or metastatic disease
- Life expectancy greater than 3 months (Arm 1) or greater than 6 months (Arm 2)
You will not qualify if you...
- Known additional malignancy that is progressing or requires active treatment
- Known active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known history of HIV infection
- Known history of Hepatitis B or active Hepatitis C virus
- Previous solid organ transplant or allogeneic hematopoietic stem cell transplant within last 5 years
- Incomplete recovery from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Nagoya City University Hospital ( Site 0003)
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
2
Sapporo Hokuyu Hospital ( Site 0005)
Sapporo, Hokkaido, Japan, 003-0006
Actively Recruiting
3
National Hospital Organization Kyushu Cancer Center ( Site 0001)
Fukuoka, Japan, 811-1395
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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