Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667) (NCT03407144)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (21 items).
Location: Children's Hospital of Alabama ( Site 0023) โ Birmingham, Alabama
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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 24 hours before the first dose of study treatment
- Baseline left ventricular ejection fraction value \<50% or shortening fraction of \<27%
- 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 MSD pembrolizumab (MK-3475) clinical study
- Has received any prior systemic anti-cancer therapy,including investigational agents for current diagnosis before randomization
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
- Has a known additional malignancy that is progressing or requires active treatment within the past 3 years
- Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (93 Sites)
- Children's Hospital of Alabama ( Site 0023) โ Birmingham, Alabama
- Phoenix Childrens Hospital ( Site 0034) โ Phoenix, Arizona
- Arkansas Children's Hospital ( Site 0046) โ Little Rock, Arkansas
- Kaiser - Orange County ( Site 0084) โ Anaheim, California
- Kaiser Permanente ( Site 0082) โ Downey, California
- Kaiser - Fontana ( Site 0083) โ Fontana, California
- MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si โ Long Beach, California
- Kaiser Permanente Downey Medical Center ( Site 0024) โ Los Angeles, California
- Kaiser Permanente - Oakland ( Site 0047) โ Oakland, California
- Kaiser Permanente - Roseville ( Site 0080) โ Roseville, California
- Kaiser Permanente - Santa Clara ( Site 0079) โ Santa Clara, California
- Children's Hospital - Colorado ( Site 0028) โ Aurora, Colorado
- Connecticut Children's Medical Center ( Site 0045) โ Hartford, Connecticut
- Yale Cancer Center ( Site 0061) โ New Haven, Connecticut
- Children's National Medical Center ( Site 0090) โ Washington D.C., District of Columbia
- University of Florida ( Site 0051) โ Gainesville, Florida
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048) โ Hollywood, Florida
- Arnold Palmer Hospital ( Site 0065) โ Orlando, Florida
- Children's Healthcare of Atlanta at Egleston ( Site 0033) โ Atlanta, Georgia
- University of Chicago ( Site 0066) โ Chicago, Illinois
- Riley Hospital for Children ( Site 0091) โ Indianapolis, Indiana
- University of Kentucky Markey Cancer Center ( Site 0057) โ Lexington, Kentucky
- University of Louisville-Norton Children's Hospital ( Site 0059) โ Louisville, Kentucky
- Johns Hopkins University ( Site 0025) โ Baltimore, Maryland
- Children's Hospital of Michigan ( Site 0056) โ Detroit, Michigan
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.