Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT03407144

PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

3 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2018-04-09

Completion Date

2026-11-06

Last Updated

2026-02-19

Healthy Volunteers

Conditions

Hodgkin Lymphoma

Interventions

BIOLOGICAL

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

DRUG

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)

DRUG

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)

DRUG

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)

DRUG

cyclophosphamide

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

DRUG

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)

DRUG

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)

DRUG

bleomycin

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

DRUG

etoposide

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

RADIATION

Radiotherapy (RT)

RT administered daily, dose dependent on randomization group and disease response.

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

Locations (93)

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

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

Hospital Pablo Tobon Uribe-Hematology ( Site 0565)

Medellín, Antioquia, Colombia

Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529)

Barranquilla, Atlántico, Colombia

Instituto Nacional De Cancerologia ( Site 0566)

Bogotá, Bogota D.C., Colombia

Oncomédica S.A.S ( Site 0527)

Montería, Departamento de Córdoba, Colombia

Fakultni nemocnice v Motole ( Site 0356)

Prague, Czechia

Institut d'Hematologie-Oncologie Pediatrique (IHOP) ( Site 0448)

Lyon, Auvergne-Rhône-Alpes, France

CHU de Marseille Hopital de la Timone Enfants ( Site 0449)

Marseille, Bouches-du-Rhone, France

CHU de Bordeaux. Hopital Pellegrin ( Site 0447)

Bordeaux, Gironde, France

Hôpital Jeanne de Flandre ( Site 0450)

Lille, Nord, France

Institut Gustave Roussy ( Site 0445)

Villejuif, Val-de-Marne, France

Hopital d'Enfants Armand Trousseau ( Site 0443)

Paris, France

Hopital Universitaire Robert Debre ( Site 0446)

Paris, France

Klinikum der Universitaet Muenchen-Campus Innenstadt ( Site 0414)

Munich, Bavaria, Germany

Universitaetsklinikum Giessen und Marburg GmbH ( Site 0411)

Giessen, Hesse, Germany

Universitaetsklinikum Essen ( Site 0415)

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Sit

Münster, North Rhine-Westphalia, Germany

Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0413)

Berlin, Germany

Athens Childrens Hospital Aglaia Kyriakou ( Site 0361)

Athens, Attica, Greece

University of Athens - Aghia Sophia Childrens Hospital ( Site 0362)

Athens, Attica, Greece

University General Hospital of Thessaloniki "AHEPA" ( Site 0363)

Thessaloniki, Central Macedonia, Greece

Oncomedica ( Site 0545)

Guatemala City, Guatemala

Unidad Nacional de Oncologia Pediatrica ( Site 0542)

Guatemala City, Guatemala

Medi-K Cayala ( Site 0544)

Guatemala City, Guatemala

Universita degli Studi di Roma La Sapienza ( Site 0403)

Roma, Abruzzo, Italy

Centro di Riferimento Oncologico CRO ( Site 0404)

Aviano, Pordenone, Italy

Azienda Ospedaliera Santobono - Pausilipon ( Site 0402)

Naples, Italy

IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0400)

Roma, Italy

Ospedale Infantile Regina Margherita ( Site 0401)

Torino, Italy

Hospital Infantil de Mexico Federico Gomez ( Site 0535)

Mexico City, Mexico City, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0531)

Monterrey, Nuevo León, Mexico

UMAE Hospital de Especialidades - CMN La Raza ( Site 0536)

Azcapotzalco, Mexico

Hematologica Alta Especialidad ( Site 0532)

Huixquilucan, Mexico

Prinses Maxima Centrum ( Site 0461)

Utrecht, Netherlands

Narodny ustav detskych chorob ( Site 0372)

Bratislava, Bratislava Region, Slovakia

Wits Clinical Research ( Site 0323)

Johannesburg, Gauteng, South Africa

Albert Alberts Stem Cell Transplant Centre ( Site 0324)

Pretoria, Gauteng, South Africa

Wits Clinical Research ( Site 0321)

Soweto, Gauteng, South Africa

Severance Hospital Yonsei University Health System ( Site 0221)

Seoul, South Korea

Samsung Medical Center ( Site 0222)

Seoul, South Korea

Hospital Universitari Vall d Hebron ( Site 0432)

Barcelona, Spain

Hospital Infantil Universitario Nino Jesus ( Site 0433)

Madrid, Spain

Hospital Universitario La Paz ( Site 0434)

Madrid, Spain

University College London Hospitals NHS Foundation Trust ( Site 0454)

London, London, City of, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (93)