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Clinical Trials in the UK / NCT03407144
Active, not recruiting Phase 2

Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)

NCT03407144 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2018-04-09
Last updated
2026-09-15

Condition(s) studied

Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

pembrolizumabdoxorubicinvinblastinedacarbazinecyclophosphamidevincristineprednisone/prednisolonebleomycinetoposideRadiotherapy (RT)

pembrolizumab: 2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W

doxorubicin: 25 mg/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 40 mg/m\^2 IV on Days 1 and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 25 mg/m\^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)

vinblastine: 6 mg/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 6 mg/m\^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)

dacarbazine: 375 mg/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 375 mg/m\^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1) 250 mg/m\^2 IV on Days 1 to 3 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)

cyclophosphamide: 500 mg/m\^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)

vincristine: 1.5 mg/m\^2 IV with maximum single dose 2 mg on Days 1, 8, and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 1.5 mg/m\^2 IV with maximum single dose 2 mg on Days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)

prednisone/prednisolone: 60 mg/m\^2/day orally divided in 3 doses on Days 1 to 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 40 mg/m\^2/day orally divided in 3 doses on Days 1 to 15 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)

bleomycin: 10 units/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)

etoposide: 125 mg/m\^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)

Radiotherapy (RT): RT administered daily, dose dependent on randomization group and disease response.

Study 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
25 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (93)

FacilityCityRegionStatus
Children's Hospital of Alabama ( Site 0023) Birmingham Alabama
Phoenix Childrens Hospital ( Site 0034) Phoenix Arizona
Arkansas Children's Hospital ( Site 0046) Little Rock Arkansas
Kaiser - Orange County ( Site 0084) Anaheim California
Kaiser Permanente ( Site 0082) Downey California
Kaiser - Fontana ( Site 0083) Fontana California
MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si Long Beach California
Kaiser Permanente Downey Medical Center ( Site 0024) Los Angeles California
Kaiser Permanente - Oakland ( Site 0047) Oakland California
Kaiser Permanente - Roseville ( Site 0080) Roseville California
Kaiser Permanente - Santa Clara ( Site 0079) Santa Clara California
Children's Hospital - Colorado ( Site 0028) Aurora Colorado
Connecticut Children's Medical Center ( Site 0045) Hartford Connecticut
Yale Cancer Center ( Site 0061) New Haven Connecticut
Children's National Medical Center ( Site 0090) Washington D.C. District of Columbia
University of Florida ( Site 0051) Gainesville Florida
Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048) Hollywood Florida
Arnold Palmer Hospital ( Site 0065) Orlando Florida
Children's Healthcare of Atlanta at Egleston ( Site 0033) Atlanta Georgia
University of Chicago ( Site 0066) Chicago Illinois
Riley Hospital for Children ( Site 0091) Indianapolis Indiana
University of Kentucky Markey Cancer Center ( Site 0057) Lexington Kentucky
University of Louisville-Norton Children's Hospital ( Site 0059) Louisville Kentucky
Johns Hopkins University ( Site 0025) Baltimore Maryland
Children's Hospital of Michigan ( Site 0056) Detroit Michigan
Karmanos Cancer Institute ( Site 0002) Detroit Michigan
Children's Hospitals and Clinics of Minnesota ( Site 0036) Minneapolis Minnesota
St. Louis Children's Hospital ( Site 0038) St Louis Missouri
Alliance for Childhood Diseases ( Site 0064) Las Vegas Nevada
Hackensack University Medical Center ( Site 0026) Hackensack New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0027) New Brunswick New Jersey
Roswell Park Cancer Institute ( Site 0040) Buffalo New York
Cohen Children's Medical Center of New York ( Site 0052) New Hyde Park New York
Columbia University/Herbert Irving Cancer Center ( Site 0063) New York New York
Memorial Sloan Kettering Cancer Center ( Site 0060) New York New York
Weill Cornell Medicine ( Site 0032) New York New York
UNC Lineberger Comprehensive Cancer ( Site 0044) Chapel Hill North Carolina
Cincinnati Children's Hospital Medical Center ( Site 0035) Cincinnati Ohio
Nationwide Children's Hospital ( Site 0037) Columbus Ohio
St. Francis Hospital Cancer Center ( Site 0001) Greenville South Carolina

+ 53 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03407144 on ClinicalTrials.gov ↗ ← All trials in the UK