KEYNOTE-667 ( MK-3475-667, Pembrolizumab)
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)
Summary
This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.
Pembrolizumab (MK-3475) is a monoclonal antibody that blocks the PD1 receptor. Some types of cancer produce a protein (PD-L1) that prevents the body's immune cells (by binding to the PD1 receptor) from recognizing the cancer and fighting it effectively. By blocking the PD-1 receptor, PD-L1 can no longer impede the immune cells. The cancer is visible to the immune system and can be fought by the body. Pembrolizumab is approved for the treatment of advanced cancer in adults and is administered intravenous.
Main inclusion criteria
- Group 1: Must have newly diagnosed, pathologically confirmed classical Hodgkin Lymphoma (cHL) at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB
- Has measurable disease per investigator assessment
- Age: 3 to 25 years
- Lansky/Karnovsky Score ≥50
Sponsor
Merck Sharp Dohme Corp.