Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
NCT ID: NCT03407144
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
340 participants
INTERVENTIONAL
2018-04-09
2027-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab + AVD (Group 1)
After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2 and dacarbazine 375 mg/m\^2 on Days 1 and 15; cycle frequency every 4 weeks \[Q4W\]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.
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)
bleomycin
10 units/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)
Radiotherapy (RT)
RT administered daily, dose dependent on randomization group and disease response.
Pembrolizumab + COPDAC-28 (Group 2)
After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m\^2 on Days 1 and 8, vincristine 1.5 mg/m\^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m\^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m\^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.
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)
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)
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
25 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
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)
Napoli, , 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
Countries
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References
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Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-667
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504821-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-001123-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-667
Identifier Type: -
Identifier Source: org_study_id
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