MEKPEM: A Phase I/II trial of MK-3475 (pembrolizumab) in children’s solid tumors and lymphomas

A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced Relapsed or Refractory Solid Tumor or Lymphoma (Merck study KEYNOTE-051, IND# 110,080, dated 10-15/2014). EudraCT NUMBER: 2014-002950-38

Categories:

Solid Tumor

Phase I/II

Diseases Treated:

Advanced melanoma or PD-L1 positive advanced relapsed or refractory solid tumor or lymphoma

Eligibility Overview:

  • Between 6 months and 18 years old with  diagnosis of advanced melanoma or PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma, or MSI-H solid tumor
    OR
  • Between 3 and 18 years of age with relapsed or refractory classical Hodgkin lymphoma
  • Negative pregnancy test 72 hours prior to medication administration in participants of child-bearing potential
  • Appropriate liver and kidney functions
  1. Brief Summary

    This study will assess the activity of pembrolizumab in pediatric tumors, especially in patients who are refractory to available treatments.

    Results from the Part I dose finding and confirmation approach in this study will be used for an initial benefit-risk assessment, which in turn would support the generation of additional data in Part II of this study.

    Part II focuses on the solid tumors most likely to show improvement, including advanced melanoma, advanced relapsed or refractory solid tumors or other lymphoma that are shown to be PD-L1 positive and advanced, relapsed or refractory MSI-H solid tumors, for which no effective treatment is currently known.

    Primary Objectives

    • Test the safety and anti-tumor activity of pembrolizumab (formerly called MK-3475)
    • To learn more about the side effects of pembrolizumab
    • Look for the highest dose of pembrolizumab that can be given safely without serious side effects
    • Find out how pembrolizumab is absorbed and broken down

    Inclusion criteria (among others)

    • Between 6 months and 18 years old (at pre-screening) with diagnosis of advanced melanoma, PD-L1 positive advanced, relapsed or refractory solid tumor, or lymphoma as determined by immunohistochemistry of archival formalin fixed paraffin embedded tumor (FFPET) or newly obtained tissue  In the future as determined by the sponsor, PD-L1 negative tumors might be eligible.
      OR
    • Between 3 and 18 years of age (at pre-screening) with relapsed or refractory classical Hodgkin lymphoma
    • Participants of child bearing potential: negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Appropriate liver and kidney function as determined by protocol specific lab value criteria (see protocol for lab specific lab values)

    Exclusion criteria (among others)

    • Currently participating and receiving study therapy, in or has participated in a study of an investigational agent and received study therapy or used an investigational device within four weeks of the first dose of study treatment
    • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any form of immunosuppressive therapy within seven days prior to the first dose of trial treatment
      Note: The use of physiologic doses of corticosteroids (up to 5mg/m2/day prednisone equivalent) may be approved after consultation with the Sponsor.
    • Known additional malignancy that is progressing or requires active treatment.
      Note: Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer).
    • Active autoimmune disease that has required systemic treatment in past two (2) years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
      Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  2. About this study

    This study will enroll participants who have melanoma or other solid tumors or lymphoma that is growing or has come back after receiving standard therapy. People with these conditions are usually treated with surgeries and/or chemotherapy using drugs approved by the U.S. Food and Drug Administration (FDA) because there is no standard therapy for this type of cancer. The drug in this study is called pembrolizumab.

    Before enrolling, prospective participants will be screened. This process will include certain exams, tests, or procedures to make sure this study is a good option for them.

    Purpose of this clinical trial

    The main goal of the study is to see how safe and effective pembrolizumab is in treating children with these conditions. Researchers also want to learn the good and bad side effects of this medicine.

    Eligibility overview

    • Between 6 months and 18 years old with  diagnosis of advanced melanoma or PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma, or MSI-H solid tumor
      OR
    • Between 3 and 18 years of age with relapsed or refractory classical Hodgkin lymphoma
    • Negative pregnancy test 72 hours prior to medication administration in participants of child-bearing potential
    • Appropriate liver and kidney functions
  3. MEKPEM Quick View
    Sponsor Merk Sharp & Dohme Corp.
    ClinicalTrials.gov Identifier NCT02332668
    Trial Start Date March 2015
    Estimated Enrollment 310
    Study Type Interventional
    Study Phase Phase I/II
    Conditions Melanoma, solid tumors, lymphoma
    Ages 6 months to 18 years old
    Principal Investigator Alberto Pappo, MD (St. Jude)
    Study Sites St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss MEKPEM St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.