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Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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)
 
Region Sponsors
California - Northern
Children's Oncology Group
 
Acronym KP IRB No.
1492804
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma.
 
Purpose
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.
 
Detailed Description
Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.
 
Gender Age Limit
Male & Female 3 - 25 years
 
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
 
Exclusion Criteria
  • Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years
  • WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment
  • Baseline left ventricular ejection fraction value
  • Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study
  • Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Pembrolizumab
  • Lymphoproliferative Disorders
  • Antineoplastic Agents, Alkylating
  • Methylprednisolone
  • Antirheumatic Agents
  • Methylprednisolone Acetate
  • Bleomycin
  • Methylprednisolone Hemisuccinate
  • Cyclophosphamide
  • Neoplasms
  • Doxorubicin
  • Neoplasms by Histologic Type
  • Etoposide
  • Physiological Effects of Drugs
  • Etoposide phosphate
  • Prednisolone
  • Hodgkin Disease
  • Prednisolone acetate
  • Immune System Diseases
  • Prednisolone hemisuccinate
  • Immunologic Factors
  • Prednisolone phosphate
  • Immunoproliferative Disorders
  • Prednisone
  • Immunosuppressive Agents
  • Vinblastine
  • Liposomal doxorubicin
  • Vincristine
  • Lymphatic Diseases
  • Oncology (Pediatrics)
  • Lymphoma
 
KP Clinical Facility
  • Oakland Medical Center
  • Roseville Medical Center
  • Santa Clara Medical Center-Homestead
 
Clinical Area
  • Oncology (Pediatrics)


Principal Investigator:
Laura Campbell, MD
Contact Information:
- KPNC Comprehensive Clinical Research Unit
-susan.x.leu@kp.org
-Oakland Medical Center


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