NCT07302347 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)
| NCT ID | NCT07302347 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Malignant Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-23 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-06-23 with a primary completion date of 2029-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Arm 1: * For participants with relapsed or refractory classical Hodgkin lymphoma (cHL) or primary mediastinal large B-cell lymphoma (PMBCL) * Has a confirmed diagnosis of relapsed or refractory cHL or PMBCL after the most recent therapy * Has radiographically measurable disease per Lugano classification * For participants with completely resected melanoma: * Has surgically completely resected and histologically/pathologically confirmed diagnosis of Stage IIB, IIC, III or IV cutaneous melanoma * Has not received any prior systemic therapy for their melanoma beyond surgical resection * All suspicious lesions amenable to biopsy are confirmed negative for malignancy * For participants with locally advanced or metastatic melanoma: * Has histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma (including acral) not amenable to local therapy * Has radiographically measurable lesion(s) as defined by RECIST 1.1 * For participants with microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) solid tumors: * Has histologically/cytologically documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the participant and treating physician * Has a documented positive local MSI-H or dMMR test result * Has radiographically measurable disease based on RECIST 1.1 * For participants with tumor mutational burden-high (TMB-H) solid tumors: * Has histologically/cytologically documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the participant and treating physician * Has radiographically measurable disease based on RECIST 1.1 * For participants with MCC: * Has histologically confirmed diagnosis of locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy and is not amenable to local therapy or metastatic MCC (Stage IV) * Has radiographically measurable disease based on RECIST 1.1 Arm 2: * For participants with MCC: * Has been untreated for advanced or metastatic disease Arm 1 \& Arm 2: * Life expectancy of \>3 months (Arm 1) or \>6 months (Arm 2) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has known additional malignancy that is progressing or has required active treatment * Has known active (central nervous system) CNS metastases and/or carcinomatous meningitis * Has active autoimmune disease that has required systemic treatment in past 2 years * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has known history of human immunodeficiency virus (HIV) infection * Has known history of Hepatitis B infection or known active Hepatitis C virus * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years * Has not adequately recovered from major surgery or has ongoing surgical complications
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07302347 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, studying Malignant Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07302347 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07302347 currently recruiting?
Yes, NCT07302347 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07302347 trial being conducted?
This trial is being conducted at Nagoya, Japan, Nagoya, Japan, Sapporo, Japan, Kobe, Japan and 3 additional locations.
Who is sponsoring the NCT07302347 clinical trial?
NCT07302347 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 20 participants.