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)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorMerck Sharp & Dohme LLC

About this trial

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

Qualifiers

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

Has surgically completely resected and histologically/pathologically confirmed diagnosis of Stage IIB, IIC, III or IV cutaneous melanoma

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pembrolizumab

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

7
Nagoya City University Hospital ( Site 0003)467-8602, NagoyaAichi-ken, Japan
Nagoya City University Hospital ( Site 0007)467-8602, NagoyaAichi-ken, Japan
Sapporo Hokuyu Hospital ( Site 0005)003-0006, SapporoHokkaido, Japan
Hyogo Prefectural Kobe Children's Hospital ( Site 0006)650-0047, KobeHyōgo, Japan

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor