- A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051) — Recruiting • Phase I • Oncology • NCT02332668.
- What is being tested: Pembrolizumab (an anti-PD-1 immunotherapy checkpoint inhibitor) is being evaluated for efficacy and safety in pediatric patients with advanced solid tumors, melanoma, or lymphomas that are either metastatic or unresectable.
- Patient eligibility overview: The trial enrolls children with confirmed advanced malignancies (melanoma, solid tumors, or lymphomas) that have progressed despite standard treatment or for which no standard therapy exists; specific age ranges and performance status criteria apply.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : * Between 6 months and 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.