Pembrolizumab treatment for Japanese children with solid tumors or lymphomas and Japanese adults with Merkel cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2, open-label trial gives pembrolizumab to Japanese pediatric participants with solid tumors or lymphomas and to Japanese adults with Merkel cell carcinoma to collect safety, pharmacokinetic, and tumor response data. Participants are enrolled into cohorts based on cancer type (for example relapsed or refractory classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, resected or advanced melanoma, or Merkel cell carcinoma) and receive defined doses of pembrolizumab with regular monitoring for side effects and radiographic tumor measurements. Early-phase dosing and pharmacokinetic sampling will guide safe dose selection, followed by expansion cohorts to observe antitumor activity. The trial is sponsored by Merck Sharp & Dohme and is conducted at multiple hospitals in Japan.

Why it matters

Who can join: the full rules

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

Where it's running

• Nagoya City University Hospital ( Site 0003)
  Nagoya, Aichi-ken, Japan Recruiting
• Nagoya City University Hospital ( Site 0007)
  Nagoya, Aichi-ken, Japan Recruiting
• Sapporo Hokuyu Hospital ( Site 0005)
  Sapporo, Hokkaido, Japan Recruiting
• Hyogo Prefectural Kobe Children's Hospital ( Site 0006)
  Kobe, Hyōgo, Japan Recruiting
• National Cancer Center Hospital ( Site 0002)
  Chūō, Tokyo, Japan Recruiting
• National Hospital Organization Kyushu Cancer Center ( Site 0001)
  Fukuoka, Japan Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.