A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
6 Months - 17 Years, Male and Female
3475-051 (primary)
NCI-2015-00528
2014-002950-38
Summary
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), or
- advanced relapsed or refractory tumor-mutational burden-high â?¥10 mutation/Mb (TMB-H)
solid tumors (6 months to <18 years of age), or
- with adjuvant treatment of resected high-risk Stage IIB, IIC, III, or IV melanoma in
children 12 years 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. The 10% assessment does not apply to the
MSI-H and TMB-H cohorts.
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 â?¥12 years
to â?¤18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H
solid tumors also continues.
Eligibility
- 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 â?¥50 for participants from 6 months up to and including 16 years of age; or Karnofsky score â?¥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.
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