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A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)

370 patients around the world

Available in United States

Merck Sharp & Dohme Corp.

370Patients around the world

This study is for people with

Skin cancer

Melanoma

Lymphoma

Hodgkin lymphoma

Solid tumors

Requirements for the patient

To 17 Years

All Gender

Medical requirements

: Between 6 months and <18 years of age on day of signing informed consent is documented.
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 (or lymph node biopsy for rrcHL participants) 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 (Or based on IWG [Cheson, 2007] [i.e., measurement must be >15 mm in longest diameter or >10 mm in short axis] for rrcHL participants)
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 before the first dose of study medication
Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who is abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of study intervention
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Demonstrate adequate organ function.

: 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 date of allocation/randomization
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the date of allocation/randomization
Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
Prior radiotherapy within 2 weeks of start of study treatment
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 or carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) 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
Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
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 (anti-PD-L1), anti-PD-L2 agent, or any agent directed to another stimulatory or inhibitory T-cell receptor (eg, cytotoxic lymphocyte associated protein-4 [CTLA-4], OX-40, CD137)
Human immunodeficiency virus (HIV)
Hepatitis B or C
Known history of active tuberculosis (TB; Bacillus tuberculosis)
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 an allogeneic hematopoietic 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 study
Known psychiatric or substance abuse disorders that would interfere with the requirements of the study

SponsorMerck Sharp & Dohme Corp.

Study typeInterventional

Conditions

MelanomaHodgkin lymphomaSolid tumors

Requirements

To 17 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT02332668