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A Study of Pembrolizumab (MK-3475) in Pediatric Participants With Advanced Melanoma or Advanced, Relapsed, or Refractory PD-L1-Positive Solid Tumors or Lymphoma (MK-3475-051/KEYNOTE-051)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02332668
First received: January 6, 2015
Last updated: June 5, 2017
Last verified: June 2017
  Purpose
This is a 2-part study of pembrolizumab (MK-3475) in pediatric participants who have either advanced melanoma or a programmed cell death ligand 1 (PD-L1)-positive advanced, relapsed or refractory solid tumor or other lymphoma. Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D.

Condition Intervention Phase
Melanoma Lymphoma Solid Tumor Biological: Pembrolizumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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 (KEYNOTE-051)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Site Assessment [ Time Frame: Up to 2 years ]
  • Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Up to 21 days) ]
  • Area Under the Concentration Curve (AUC) for Pembrolizumab [ Time Frame: Predose Cycles 1, 2, 4, 8 and every 4 cycles thereafter, and within 30 minutes post infusion at Cycles 1 and 8. Additional single PK samples in Cycle 1 between 72 to 168 hours post-dose, and Cycle 1 at 336 hours post-dose. ]
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 2 years ]
  • Number of Participants Discontinuing Study Drug Due to AEs [ Time Frame: Up to 2 years ]

Estimated Enrollment: 310
Actual Study Start Date: March 18, 2015
Estimated Study Completion Date: January 2, 2019
Estimated Primary Completion Date: January 2, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab
Participants receive pembrolizumab, starting dose 2 mg/kg, intravenously (IV) every 3 weeks (Q3W).
Biological: Pembrolizumab
IV infusion
Other Name: MK-3475

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 6 months and less than 18 years of age on day of signing informed consent/assent (the first 3 participants dosed in Part 1 are to be >= 6 years of age)
  • Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate
  • Any number of prior treatment regimens
  • Tissue available from an archival tissue sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
  • Measurable disease based on RECIST 1.1
  • Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
  • Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years of age; or Karnofsky score ≥50 for participants >16 years of age
  • Adequate organ function
  • Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
  • Female participants of childbearing potential must be willing to use 2 methods of contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
  • Male participants must agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication

Exclusion Criteria:

  • 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 4 weeks of the first dose of study medication
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
  • Anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered adverse events due to mAbs administered more than 4 weeks earlier
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
  • Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin with potentially curative therapy, or in situ cervical cancer
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Tumor(s) involving the brain stem
  • Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Active infection requiring systemic therapy
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of study medication
  • Prior therapy with an anti-programmed cell death (PD)-1, anti-PD ligand 1 (L1), or anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4) agent, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Human immunodeficiency virus (HIV)
  • Hepatitis B or C
  • Received a live vaccine within 30 days of planned start of study medication
  • Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had a transplant >5 years ago are eligible as long as there are no symptoms of Graft Versus Host Disease [GVHD].)
  • History or current evidence of any condition, therapy, or laboratory abnormality, or known severe hypersensitivity to any component or analog of the trial treatment, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the trial
  • Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02332668

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 47 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02332668     History of Changes
Other Study ID Numbers: 3475-051
2014-002950-38 ( EudraCT Number )
Study First Received: January 6, 2015
Last Updated: June 5, 2017

Keywords provided by Merck Sharp & Dohme Corp.:
PD1
PD-1
PDL1
PD-L1

Additional relevant MeSH terms:
Lymphoma
Melanoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 26, 2017