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NCT07302347Toboroz1/2. fázis

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)

A Phase I/II Study of Pembrolizumab (MK-3475) in Japanese Pediatric Participants With Specific Solid Tumors or Lymphomas, or in Japanese Adult Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-G21)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 13.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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

Állapot (regiszter)
Toboroz
Fázis (regiszter)
1/2. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
20 (tervezett)
Első benyújtás
2025. dec. 11.
Kezdés
2026. jún. 23.
Elsődleges befejezés
2029. márc. 30.
Fő szponzor
Merck Sharp & Dohme LLC
NCT-szám
NCT07302347

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
  • Tervezett résztvevők: 20
  • 2026. jún. 23. és az elsődleges befejezés (2029. márc. 30.) között
  • 7 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

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Korábbi kezelés

  • 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

Más betegség

  • Has known additional malignancy that is progressing or has required active treatment
  • 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

Egyéb

  • The main exclusion criteria include but are not limited to the following:
  • Has known active (central nervous system) CNS metastases and/or carcinomatous meningitis

Kiket keres a vizsgálat

  • 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)

Életkor a regiszterben: 6 hónap – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (7)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
National Cancer Center Hospital (Site 0002)ChūōJapánToboroz
National Hospital Organization Kyushu Cancer Center (Site 0001)FukuokaJapánToboroz
Hyogo Prefectural Kobe Children's Hospital (Site 0006)KobeJapánToboroz
University Hospital,Kyoto Prefectural University of Medicine (Site 0004)KyotoJapánToboroz
Nagoya City University Hospital (Site 0007)NagoyaJapánToboroz
Nagoya City University Hospital (Site 0003)NagoyaJapánToboroz
Sapporo Hokuyu Hospital (Site 0005)SapporoJapánToboroz

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