Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
Run by Merck Sharp & Dohme LLC · NCT03407144 · Data updated 2026-11-12
Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2027-02-12.
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 25 Years |
| Sex | All |
| Enrollment | 340 (estimated) |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | pembrolizumab, doxorubicin, vinblastine, dacarbazine, cyclophosphamide, vincristine, prednisone/prednisolone, bleomycin, etoposide, Radiotherapy (RT) |
| Locations | 93 sites (Brazil, Colombia, Czechia, France, Germany, Greece, Guatemala, Italy and more) |
| Trial ID | NCT03407144 on ClinicalTrials.gov |
What this trial studies
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.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. * Male participants are eligible to participate if they agree to the following during the intervention period: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per protocol unless confirmed to be azoospermic. * 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 intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. * Performance status: Lansky Play-Performance Scale ≥50 for children up to 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 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 * Has severe hypersensitivity (≥Grade 3) to any study therapies including any excipients * An active autoimmune disease that has required systemic treatment in past 2 years * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection * Has a known history of Hepatitis B or known active Hepatitis C virus infection * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study * Participants who have not adequately recovered from major surgery or have ongoing surgical complications
Where it's running
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Children's Hospital of Alabama ( Site 0023)
Birmingham, Alabama, United States -
Phoenix Childrens Hospital ( Site 0034)
Phoenix, Arizona, United States -
Arkansas Children's Hospital ( Site 0046)
Little Rock, Arkansas, United States -
Kaiser - Orange County ( Site 0084)
Anaheim, California, United States -
Kaiser Permanente ( Site 0082)
Downey, California, United States -
Kaiser - Fontana ( Site 0083)
Fontana, California, United States
Show 44 more locations
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MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si
Long Beach, California, United States -
Kaiser Permanente Downey Medical Center ( Site 0024)
Los Angeles, California, United States -
Kaiser Permanente - Oakland ( Site 0047)
Oakland, California, United States -
Kaiser Permanente - Roseville ( Site 0080)
Roseville, California, United States -
Kaiser Permanente - Santa Clara ( Site 0079)
Santa Clara, California, United States -
Children's Hospital - Colorado ( Site 0028)
Aurora, Colorado, United States -
Connecticut Children's Medical Center ( Site 0045)
Hartford, Connecticut, United States -
Yale Cancer Center ( Site 0061)
New Haven, Connecticut, United States -
Children's National Medical Center ( Site 0090)
Washington D.C., District of Columbia, United States -
University of Florida ( Site 0051)
Gainesville, Florida, United States -
Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048)
Hollywood, Florida, United States -
Arnold Palmer Hospital ( Site 0065)
Orlando, Florida, United States -
Children's Healthcare of Atlanta at Egleston ( Site 0033)
Atlanta, Georgia, United States -
University of Chicago ( Site 0066)
Chicago, Illinois, United States -
Riley Hospital for Children ( Site 0091)
Indianapolis, Indiana, United States -
University of Kentucky Markey Cancer Center ( Site 0057)
Lexington, Kentucky, United States -
University of Louisville-Norton Children's Hospital ( Site 0059)
Louisville, Kentucky, United States -
Johns Hopkins University ( Site 0025)
Baltimore, Maryland, United States -
Children's Hospital of Michigan ( Site 0056)
Detroit, Michigan, United States -
Karmanos Cancer Institute ( Site 0002)
Detroit, Michigan, United States -
Children's Hospitals and Clinics of Minnesota ( Site 0036)
Minneapolis, Minnesota, United States -
St. Louis Children's Hospital ( Site 0038)
St Louis, Missouri, United States -
Alliance for Childhood Diseases ( Site 0064)
Las Vegas, Nevada, United States -
Hackensack University Medical Center ( Site 0026)
Hackensack, New Jersey, United States -
Rutgers Cancer Institute of New Jersey ( Site 0027)
New Brunswick, New Jersey, United States -
Roswell Park Cancer Institute ( Site 0040)
Buffalo, New York, United States -
Cohen Children's Medical Center of New York ( Site 0052)
New Hyde Park, New York, United States -
Columbia University/Herbert Irving Cancer Center ( Site 0063)
New York, New York, United States -
Memorial Sloan Kettering Cancer Center ( Site 0060)
New York, New York, United States -
Weill Cornell Medicine ( Site 0032)
New York, New York, United States -
UNC Lineberger Comprehensive Cancer ( Site 0044)
Chapel Hill, North Carolina, United States -
Cincinnati Children's Hospital Medical Center ( Site 0035)
Cincinnati, Ohio, United States -
Nationwide Children's Hospital ( Site 0037)
Columbus, Ohio, United States -
St. Francis Hospital Cancer Center ( Site 0001)
Greenville, South Carolina, United States -
Vanderbilt University Medical Center-Ingram Cancer Center ( Site 0054)
Nashville, Tennessee, United States -
Dell Children's Medical Center Of Central Texas ( Site 0058)
Austin, Texas, United States -
Children's Medical Center ( Site 0030)
Dallas, Texas, United States -
Texas Children's Hospital ( Site 0042)
Houston, Texas, United States -
Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute ( Site
San Antonio, Texas, United States -
Inova Fairfax Hospital ( Site 0031)
Falls Church, Virginia, United States -
Seattle Childrens Hospital ( Site 0022)
Seattle, Washington, United States -
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 0507)
Curitiba, Paraná, Brazil -
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0510)
Natal, Rio Grande do Norte, Brazil -
Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0500)
São Paulo, Brazil
+43 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Medical Director — Merck Sharp & Dohme LLC
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.