Pembrolizumab (MK-3475, KEYNOTE-051)
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With Advanced Melanoma or Advanced, Relapsed, or Refractory PD-L1-Positive Solid Tumors or Lymphoma (KEYNOTE-051)
Recruiting
Summary
Pembrolizumab (MK-3475) is approved for the treatment of advanced cancer in adults. This phase I/II trial investigates the safety and antitumour activity of pembrolizumab for pediatric patients with either advanced melanoma, a PD-L! positive advanced, relapsed or refractory solid tumor or other lymphoma. Pembrolizumab is administered intravenous.
Main inclusion criteria
- 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
- advanced melanoma (6 months to < 18 years aged) or solid tumor and other lymphomas ( 6 months to < 18 years aged)
- relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 - 18 years aged)
- advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age)
- advanced relapsed or refractory tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors (6 months to <18 years of age)
Sponsor
Merck Sharp Dohme Corp.