MEKPEM: 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:

  • Participant has advanced melanoma or PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma
  • Participant of child bearing potential has a negative pregnancy test 72 hours prior to medication administration
  • Participant has appropriate liver and kidney function

Description

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 l surgeries and/or chemotherapy using drugs approved by the Food and Drug Administration (FDA) because there is no standard therapy for this type of cancer. The drug in this study is called Pembrolizumab. Pembrolizumab is approved by the FDA to treat adults with certain types of tumors such as melanoma. It is not approved for any other type of cancer or for children. Before any participant is enrolled in this study they will go through a screening period which will include certain exams, tests, or procedures to make sure this study is a good option for the participant.

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.
  • Find out how pembrolizumab may benefit your cancer.

Inclusion criteria (among others)

  • Participant has advanced melanoma or participant has a 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.  Participant has measurable disease based on RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesion or participant has neuroblastoma with evaluable disease and is being enrolled during Part I of the trial.
  • Participant of child bearing potential should have a negative urine or serum pregnancy test within seventy-two (72) hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Participant has appropriate liver and kidney function as determined by protocol specific lab value criteria (see protocol for lab specific lab values).

Exclusion criteria (among others)

  • Participant is 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 (4) weeks of the first dose of study treatment.
  • Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any form of immunosuppressive therapy within seven (7) 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.
  • Participant has a 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).
  • Participant has an 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.

Contact

Alberto Pappo, MD

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

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: 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.