Phase
Condition
Neoplasms
Neuroblastoma
Lymphoma
Treatment
Pembrolizumab
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Between 6 months and <18 years of age on day of signing informed consent isdocumented.
Histologically- or cytologically-documented, locally-advanced, or metastatic solidmalignancy or lymphoma that is incurable and has failed prior standard therapy, orfor which no standard therapy exists, or for which no standard therapy is consideredappropriate
Any number of prior treatment regimens
Tissue (or lymph node biopsy for rrcHL participants) available from an archivaltissue sample or, if appropriate, a newly obtained core or excisional biopsy of atumor lesion not previously irradiated
Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor orlymphoma
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 rrcHLparticipants)
Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positiveevaluable disease may be enrolled
Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years ofage; or Karnofsky score ≥50 for participants >16 years of age
Adequate organ function
Female participants of childbearing potential should have a negative urine or serumpregnancy test within 72 hours before the first dose of study medication
Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBPwho is abstinent from heterosexual intercourse or using contraception during theintervention period and for at least 120 days after the last dose of studyintervention
Contraceptive use by men should be consistent with local regulations regarding themethods of contraception for those participating in clinical studies.
Demonstrate adequate organ function.
Exclusion
Exclusion Criteria:
Currently participating and receiving study therapy in, or has participated in astudy of an investigational agent and received study therapy or used aninvestigational device within 4 weeks of the date of allocation/randomization
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any otherform of immunosuppressive therapy within 7 days prior to the date ofallocation/randomization
Prior systemic anti-cancer therapy including investigational agent within 2 weeksprior to study Day 1 or not recovered from adverse events due to a previouslyadministered agent
Prior radiotherapy within 2 weeks of start of study treatment
Known additional malignancy that is progressing or requires active treatment withthe exception of basal cell carcinoma of the skin, squamous cell carcinoma of theskin or carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) withpotentially 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 corticosteroidreplacement therapy for adrenal or pituitary insufficiency) is acceptable
Has a history of (non-infectious) pneumonitis that required steroids or currentpneumonitis.
Active infection requiring systemic therapy
Pregnant or breastfeeding, or expecting to conceive or father children within theprojected duration of the trial through 120 days after the last dose of studymedication
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 orinhibitory 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 hematopoieticstem cell transplantation within the last 5 years. (Participants who have had anallogeneic hematopoietic transplant >5 years ago are eligible as long as there areno symptoms of Graft Versus Host Disease [GVHD].)
History or current evidence of any condition, therapy, or laboratory abnormality, orknown severe hypersensitivity to any component or analog of the trial treatment,that might confound the results of the trial, or interfere with the participant'sparticipation for the full duration of the study
Known psychiatric or substance abuse disorders that would interfere with therequirements of the study
Study Design
Connect with a study center
MSD Australia
North Ryde,
AustraliaSite Not Available
Merck Sharp & Dohme
North Ryde,
AustraliaActive - Recruiting
MSD Brasil
Sao Paulo,
BrazilActive - Recruiting
Merck Canada
Kirkland, Quebec H9H 3L1
CanadaSite Not Available
MSD France
Paris,
FranceActive - Recruiting
MSD Sharp & Dohme GmbH
Haar,
GermanySite Not Available
MSD Sharp & Dohme GmbH
München,
GermanyActive - Recruiting
Merck Sharp & Dohme Co. Ltd.
Hod Hasharon,
IsraelActive - Recruiting
MSD Italia S.r.l.
Rome,
ItalyActive - Recruiting
MSD Korea LTD
Seoul, 4130
Korea, Republic ofActive - Recruiting
Merck Sharp & Dohme BV
Haarlem,
NetherlandsActive - Recruiting
Merck Sharp & Dohme (New Zealand) Ltd.,
Auckland,
New ZealandSite Not Available
Merck Sharp & Dohme (New Zealand) Ltd.
Wellington,
New ZealandSite Not Available
Merck Sharp & Dohme Lda.
Paco D'arcos,
PortugalActive - Recruiting
MSD Sweden
Stockholm,
SwedenActive - Recruiting
Merck Sharp & Dohme Ltd.
Hoddesdon,
United KingdomSite Not Available
Merck Sharp & Dohme Ltd.
London,
United KingdomActive - Recruiting
Call for Information (Investigational Site 0068)
Phoenix, Arizona 85016
United StatesSite Not Available
Call for Information (Investigational Site 0060)
Loma Linda, California 92354
United StatesSite Not Available
Call for Information (Investigational Site 0050)
Los Angeles, California 90027
United StatesSite Not Available
Call for Information (Investigational Site 0058)
Madera, California 93636
United StatesSite Not Available
Call for Information (Investigational Site 0059)
Orange, California 92868
United StatesSite Not Available
Call for Information (Investigational Site 0017)
San Diego, California 92123
United StatesSite Not Available
Call for Information (Investigational Site 0018)
San Francisco, California 94158
United StatesSite Not Available
Call for Information (Investigational Site 0019)
Aurora, Colorado 80045
United StatesActive - Recruiting
Call for Information (Investigational Site 0020)
New Haven, Connecticut 06511
United StatesSite Not Available
Call for Information (Investigational Site 0021)
Washington, District of Columbia 20010
United StatesSite Not Available
Call for Information (Investigational Site 0021)
Washington, D.C., District of Columbia 20010
United StatesSite Not Available
Call for Information (Investigational Site 0065)
Atlanta, Georgia 30322
United StatesSite Not Available
Call for Information (Investigational Site 0023)
Chicago, Illinois 60611
United StatesSite Not Available
Call for Information (Investigational Site 0025)
Indianapolis, Indiana 46202
United StatesSite Not Available
Call for Information (Investigational Site 0022)
Iowa City, Iowa 52242
United StatesSite Not Available
Call for Information (Investigational Site 0026)
Boston, Massachusetts 02445
United StatesActive - Recruiting
Call for Information (Investigational Site 0027)
Ann Arbor, Michigan 48109
United StatesSite Not Available
Call for Information (Investigational Site 0052)
Minneapolis, Minnesota 55454
United StatesSite Not Available
Call for Information (Investigational Site 0057)
Kansas City, Missouri 64108
United StatesSite Not Available
Call for Information (Investigational Site 0029)
Saint Louis, Missouri 63110
United StatesSite Not Available
Call for Information (Investigational Site 0029)
St. Louis, Missouri 63110
United StatesSite Not Available
Call for Information (Investigational Site 0031)
New York, New York 10032
United StatesActive - Recruiting
Call for Information (Investigational Site 0070)
Fargo, North Dakota 58122
United StatesActive - Recruiting
Call for Information (Investigational Site 0032)
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Call for Information (Investigational Site 0033)
Cleveland, Ohio 44106
United StatesSite Not Available
Call for Information (Investigational Site 0053)
Columbus, Ohio 43017
United StatesSite Not Available
Call for Information (Investigational Site 0013)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Call for Information (Investigational Site 0034)
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Call for Information (Investigational Site 0071)
Sioux Falls, South Dakota 57117
United StatesActive - Recruiting
Call for Information (Investigational Site 0012)
Memphis, Tennessee 38105
United StatesSite Not Available
Call for Information (Investigational Site 0035)
Nashville, Tennessee 37232
United StatesSite Not Available
Call for Information (Investigational Site 0054)
Dallas, Texas 75235
United StatesActive - Recruiting
Call for Information (Investigational Site 0069)
Fort Worth, Texas 76104
United StatesSite Not Available
Call for Information (Investigational Site 0036)
Houston, Texas 77030
United StatesSite Not Available
Call for Information (Investigational Site 0056)
Salt Lake City, Utah 84113
United StatesSite Not Available
Call for Information (Investigational Site 0014)
Seattle, Washington 98105
United StatesSite Not Available
Call for Information (Investigational Site 0055)
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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