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



Status:Recruiting
Conditions:Skin Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 17
Updated:3/27/2019
Start Date:March 18, 2015
End Date:September 1, 2022
Contact:Toll Free Number
Phone:1-888-577-8839

Use our guide to learn which trials are right for you!

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)

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of
the following types of cancer:

- advanced melanoma (6 months to <18 years of age),

- advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant
solid tumor or other lymphoma (6 months to <18 years of age),

- relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age),
or

- advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6
months to <18 years of age).

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.

The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab
to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory
solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL,
will result in an Objective Response Rate (ORR) greater than 10% for at least one of these
types of cancer.

With Amendment 8, enrollment of participants with solid tumors and of participants aged 6
months to <12 years with melanoma were closed. Enrollment of participants aged ≥12 years to
≤18 years with melanoma continues. Enrollment of participants with MSI-H solid tumors also
continues.


Inclusion Criteria:

- Between 6 months and <18 years of age (or between 3 years and <18 years of age for
rrcHL participants) 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 (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 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 of reproductive potential 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 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
We found this trial at
21
sites
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Madera, CA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
North Ryde, 2113
Phone: 61 2 8988 8428
?
mi
from
North Ryde,
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials