Actively Recruiting
Phase III Study of Pembrolizumab in Japanese Children With Specific Solid Tumors or Lymphomas and Adults With Advanced Merkel Cell Carcinoma
Led by Merck Sharp & Dohme LLC · Updated on 2026-07-13
20
Participants Needed
7
Research Sites
39 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying pembrolizumab to find new treatment options for people with solid tumors, lymphomas, and Merkel cell carcinoma, a type of skin cancer. The study aims to understand the safety and tolerability of pembrolizumab, how different doses behave in the body over time, and how the cancers respond to the treatment. This research includes both pediatric patients with specific tumors and adult patients with Merkel cell carcinoma. Participants are divided into two groups pediatric patients with solid tumors or lymphomas receive pembrolizumab at 2 mgkg through an intravenous infusion every three weeks for up to 17 or 35 cycles, while adult participants with Merkel cell carcinoma receive 400 mg pembrolizumab intravenously every six weeks for up to 18 cycles. Treatment schedules and doses are carefully monitored throughout the study. During the trial, participants undergo regular assessments including imaging to measure tumor response, blood tests to monitor drug levels and immune reactions, and tracking of any side effects or adverse events. The study measures outcomes such as tumor shrinkage, survival rates, and drug concentration in the body over periods up to approximately 46 months. Safety and tolerability are closely observed, with the study lasting up to the end of 2029.
CONDITIONS
Brief 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...
- Participants with relapsed or refractory classical Hodgkin lymphoma or primary mediastinal large B-cell lymphoma confirmed after most recent therapy
- Participants with completely resected Stage IIB, IIC, III, or IV cutaneous melanoma without prior systemic therapy beyond surgery
- Participants with locally advanced or metastatic melanoma not amenable to local therapy with measurable lesions
- Participants with MSI-H or dMMR solid tumors that are incurable and have failed or are not suitable for standard therapy with measurable disease
- Participants with tumor mutational burden-high solid tumors that are incurable and have failed or are not suitable for standard therapy with measurable disease
- Participants with Merkel cell carcinoma that has recurred after standard locoregional therapy or metastatic MCC with measurable disease
- Adult participants with untreated advanced or metastatic Merkel cell carcinoma
- Life expectancy of more than 3 months (pediatric) or more than 6 months (adult)
- Age 6 months or older
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 the past 2 years
- History of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- Known history of HIV infection
- Known history of Hepatitis B or active Hepatitis C infection
- Solid organ transplant at any time or allogeneic hematopoietic stem cell transplantation within last 5 years
- Not recovered from major surgery or ongoing surgical complications
Research Team
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