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
Researchers are looking for new ways to treat children with different types of melanoma
(skin cancer), solid tumors, and lymphomas (blood cancers) that are any of these:
- Advanced, which means cancer spread in the body or cannot be removed with surgery
- Relapsed, which means cancer has come back after it had responded to previous
treatment (responded means it stopped growing, gets smaller, or disappeared)
- Refractory, which means cancer did not respond to previous treatment
Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system
fight cancer. Researchers want to learn if different doses of pembrolizumab can cause at
least 1 of the types of cancer to get smaller or go away.
With Amendment 8, enrolment of participants with solid tumours and participants 6 months
to under 12 years old with melanoma were closed. Enrolment of participants 12-18 years
old with melanoma continues. Enrolment of participants who have tumours with specific
traits (microsatellite-instability-high (MSI-H), and tumour-mutational burden-high =10
mutation/Mb (TMB-H)) 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 =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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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