Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma
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)
-
Clinical Trial Information
Trial Contact: Spinelli, Jennifer; El-Shami, Jessica; Leffin, Melissa
Trial Phone: 321.841.5357 ; 321.841.3837 ; 321.841.2008
-
IRB No: W19.243.09
Protocol Abbrev: 3475-667-01
Principal Investigator: Amy A Smith, MD
Phase: Drug: Phase II
Age Group: Pediatric
Secondary Protocol No: AHOD1822
Treatment: Biological: pembrolizumab Drug: doxorubicin Drug: vinblastine Drug: dacarbazine Drug: cyclophosphamide Drug: vincristine Drug: prednisone/prednisolone Drug: bleomycin Drug: etoposide Radiation: Radiotherapy (RT)
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT03407144
-
Objective
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.
-
Key Eligibility
Inclusion Criteria:
• Group 1: Must have newly diagnosed, pathologically confirmed 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
• Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period
• Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment
• Performance status: Lansky Play-Performance Scale ≥50 for children up to and including 16 years of age OR Karnofsky score ≥50 for participants >16 years of age
• Has adequate organ function
