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New treatment option for Malignant Neoplasm
Official title 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)
ClinicalTrials.gov ID: NCT07302347
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant neoplasm.
Also referred to as MK-3475.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- The main 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:
You likely can't join if
- 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
See the full eligibility criteria
- The main 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...
- 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...
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nagoya, Aichi-ken, Japan
- Sapporo, Hokkaido, Japan
- Kobe, Hyōgo, Japan
- Chūō, Tokyo, Japan
- Fukuoka, Japan
- Kyoto, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nagoya, Aichi-ken, Japan; Sapporo, Hokkaido, Japan; Kobe, Hyōgo, Japan; Chūō, Tokyo, Japan; Fukuoka, Japan; Kyoto, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.