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)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07302347
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Merkel Cell
  • Lymphoma
  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    25 mg/mL solution for intravenous infusion.

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Mar 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Pembrolizumab in Pediatric Participants with Solid Tumors or Lymphomas
    Pediatric participants with solid tumors or lymphomas receive 2 mg/kg pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 17 or 35 cycles.
  • Experimental: Arm 2: Pembrolizumab in Adult Participants with Merkel Cell Carcinoma (MCC)
    Adult participants with MCC receive 400 mg pembrolizumab via IV infusion on Day 1 of each 42 day (6 week) cycle, for up to 18 cycles.

Primary Outcome Measure

Arm 1: Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 28 months ]

Central Contacts

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