New study explores immunotherapy for rare cancers in japanese patients
NCT ID NCT07302347
First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times
Summary
This study is testing the drug pembrolizumab in Japanese children with solid tumors or lymphomas, and in Japanese adults with advanced Merkel cell skin cancer. The main goals are to check the drug's safety, how the body processes it, and whether tumors shrink. About 20 participants will receive the treatment to gather this information.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Hyogo Prefectural Kobe Children's Hospital ( Site 0006)
RECRUITINGKobe, Hyōgo, 650-0047, Japan
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Nagoya City University Hospital ( Site 0003)
RECRUITINGNagoya, Aichi-ken, 467-8602, Japan
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Nagoya City University Hospital ( Site 0007)
RECRUITINGNagoya, Aichi-ken, 467-8602, Japan
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National Cancer Center Hospital ( Site 0002)
RECRUITINGChūō, Tokyo, 104-0045, Japan
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National Hospital Organization Kyushu Cancer Center ( Site 0001)
RECRUITINGFukuoka, 811-1395, Japan
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Sapporo Hokuyu Hospital ( Site 0005)
RECRUITINGSapporo, Hokkaido, 003-0006, Japan
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University Hospital,Kyoto Prefectural University of Medicine ( Site 0004)
RECRUITINGKyoto, 602-8566, Japan
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