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Hodgkin LymphomaPhase 2NCT03407144

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

A Phase 2 study testing pembrolizumab, doxorubicin and vinblastine in people with Hodgkin Lymphoma, run by Merck Sharp & Dohme LLC at 93 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 25 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
pembrolizumab, doxorubicin and vinblastine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
93 sitesin 16 countries
Study dates
9 Apr 2018to 12 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

93 sites in 16 countries.

93 sites in 16 countries

United States47 sites

  • Kaiser - Orange County ( Site 0084)

    Anaheim, California, 92806

  • Children's Healthcare of Atlanta at Egleston ( Site 0033)

    Atlanta, Georgia, 30322

  • Children's Hospital - Colorado ( Site 0028)

    Aurora, Colorado, 80045

  • Dell Children's Medical Center Of Central Texas ( Site 0058)

    Austin, Texas, 78723

  • Johns Hopkins University ( Site 0025)

    Baltimore, Maryland, 21287

  • Children's Hospital of Alabama ( Site 0023)

    Birmingham, Alabama, 35233

  • Roswell Park Cancer Institute ( Site 0040)

    Buffalo, New York, 14263

  • UNC Lineberger Comprehensive Cancer ( Site 0044)

    Chapel Hill, North Carolina, 27514

  • University of Chicago ( Site 0066)

    Chicago, Illinois, 60637

  • Cincinnati Children's Hospital Medical Center ( Site 0035)

    Cincinnati, Ohio, 45229

  • Nationwide Children's Hospital ( Site 0037)

    Columbus, Ohio, 43205-2696

  • Children's Medical Center ( Site 0030)

    Dallas, Texas, 75235

  • Children's Hospital of Michigan ( Site 0056)

    Detroit, Michigan, 48201

  • Karmanos Cancer Institute ( Site 0002)

    Detroit, Michigan, 48201

  • Kaiser Permanente ( Site 0082)

    Downey, California, 90242

  • Inova Fairfax Hospital ( Site 0031)

    Falls Church, Virginia, 22042

  • Kaiser - Fontana ( Site 0083)

    Fontana, California, 92335

  • University of Florida ( Site 0051)

    Gainesville, Florida, 32610

  • St. Francis Hospital Cancer Center ( Site 0001)

    Greenville, South Carolina, 29607

  • Hackensack University Medical Center ( Site 0026)

    Hackensack, New Jersey, 07601

  • Connecticut Children's Medical Center ( Site 0045)

    Hartford, Connecticut, 06106

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048)

    Hollywood, Florida, 33021

  • Texas Children's Hospital ( Site 0042)

    Houston, Texas, 77030

  • Riley Hospital for Children ( Site 0091)

    Indianapolis, Indiana, 46202

  • Alliance for Childhood Diseases ( Site 0064)

    Las Vegas, Nevada, 89135

  • University of Kentucky Markey Cancer Center ( Site 0057)

    Lexington, Kentucky, 40536-0293

  • Arkansas Children's Hospital ( Site 0046)

    Little Rock, Arkansas, 72202

  • MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si

    Long Beach, California, 90806

  • Kaiser Permanente Downey Medical Center ( Site 0024)

    Los Angeles, California, 90027

  • University of Louisville-Norton Children's Hospital ( Site 0059)

    Louisville, Kentucky, 40202

  • Children's Hospitals and Clinics of Minnesota ( Site 0036)

    Minneapolis, Minnesota, 55404

  • Vanderbilt University Medical Center-Ingram Cancer Center ( Site 0054)

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey ( Site 0027)

    New Brunswick, New Jersey, 08901

  • Yale Cancer Center ( Site 0061)

    New Haven, Connecticut, 06510

  • Cohen Children's Medical Center of New York ( Site 0052)

    New Hyde Park, New York, 11040

  • Columbia University/Herbert Irving Cancer Center ( Site 0063)

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center ( Site 0060)

    New York, New York, 10065

  • Weill Cornell Medicine ( Site 0032)

    New York, New York, 10065

  • Kaiser Permanente - Oakland ( Site 0047)

    Oakland, California, 94611

  • Arnold Palmer Hospital ( Site 0065)

    Orlando, Florida, 32806

  • Phoenix Childrens Hospital ( Site 0034)

    Phoenix, Arizona, 85016

  • Kaiser Permanente - Roseville ( Site 0080)

    Roseville, California, 95661

  • Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute ( Site

    San Antonio, Texas, 78229

  • Kaiser Permanente - Santa Clara ( Site 0079)

    Santa Clara, California, 95051

  • Seattle Childrens Hospital ( Site 0022)

    Seattle, Washington, 98105

  • St. Louis Children's Hospital ( Site 0038)

    St Louis, Missouri, 63110

  • Children's National Medical Center ( Site 0090)

    Washington D.C., District of Columbia, 20010

Other trials in United States

France7 sites

  • CHU de Bordeaux. Hopital Pellegrin ( Site 0447)

    Bordeaux, Gironde, 33000

  • Hôpital Jeanne de Flandre ( Site 0450)

    Lille, Nord, 59037

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

    Lyon, Auvergne-Rhône-Alpes, 69008

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

    Marseille, Bouches-du-Rhone, 13005

  • Hopital d'Enfants Armand Trousseau ( Site 0443)

    Paris, 75012

  • Hopital Universitaire Robert Debre ( Site 0446)

    Paris, 75019

  • Institut Gustave Roussy ( Site 0445)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Germany5 sites

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

    Berlin, 13353

  • Universitaetsklinikum Essen ( Site 0415)

    Essen, North Rhine-Westphalia, 45147

  • Universitaetsklinikum Giessen und Marburg GmbH ( Site 0411)

    Giessen, Hesse, 35392

  • Klinikum der Universitaet Muenchen-Campus Innenstadt ( Site 0414)

    Munich, Bavaria, 80337

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

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Italy5 sites

  • Centro di Riferimento Oncologico CRO ( Site 0404)

    Aviano, Pordenone, 33081

  • Azienda Ospedaliera Santobono - Pausilipon ( Site 0402)

    Naples, 80123

  • Universita degli Studi di Roma La Sapienza ( Site 0403)

    Roma, Abruzzo, 00161

  • IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0400)

    Roma, 00165

  • Ospedale Infantile Regina Margherita ( Site 0401)

    Torino, 10126

Other trials in Italy

Colombia4 sites

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

    Barranquilla, Atlántico, 080020

  • Instituto Nacional De Cancerologia ( Site 0566)

    Bogotá, Bogota D.C., 111511

  • Hospital Pablo Tobon Uribe-Hematology ( Site 0565)

    Medellín, Antioquia, 05034

  • Oncomédica S.A.S ( Site 0527)

    Montería, Departamento de Córdoba, 230001

Other trials in Colombia

Mexico4 sites

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

    Azcapotzalco, 02990

  • Hematologica Alta Especialidad ( Site 0532)

    Huixquilucan, 52787

  • Hospital Infantil de Mexico Federico Gomez ( Site 0535)

    Mexico City, Mexico City, 06720

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

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Brazil3 sites

  • Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 0507)

    Curitiba, Paraná, 81520-060

  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0510)

    Natal, Rio Grande do Norte, 59075-740

  • Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0500)

    São Paulo, 04023-062

Other trials in Brazil

Greece3 sites

  • Athens Childrens Hospital Aglaia Kyriakou ( Site 0361)

    Athens, Attica, 115 27

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

    Athens, Attica, 115 27

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

    Thessaloniki, Central Macedonia, 546 36

Other trials in Greece

Guatemala3 sites

  • Oncomedica ( Site 0545)

    Guatemala City, 01010

  • Unidad Nacional de Oncologia Pediatrica ( Site 0542)

    Guatemala City, 01011

  • Medi-K Cayala ( Site 0544)

    Guatemala City, 01016

Other trials in Guatemala

South Africa3 sites

  • Wits Clinical Research ( Site 0323)

    Johannesburg, Gauteng, 2193

  • Albert Alberts Stem Cell Transplant Centre ( Site 0324)

    Pretoria, Gauteng, 0044

  • Wits Clinical Research ( Site 0321)

    Soweto, Gauteng, 2193

Other trials in South Africa

Spain3 sites

  • Hospital Universitari Vall d Hebron ( Site 0432)

    Barcelona, 08035

  • Hospital Infantil Universitario Nino Jesus ( Site 0433)

    Madrid, 28009

  • Hospital Universitario La Paz ( Site 0434)

    Madrid, 28046

Other trials in Spain

South Korea2 sites

  • Severance Hospital Yonsei University Health System ( Site 0221)

    Seoul, 03722

  • Samsung Medical Center ( Site 0222)

    Seoul, 06351

Other trials in South Korea

Czechia1 site

  • Fakultni nemocnice v Motole ( Site 0356)

    Prague, 150 06

Other trials in Czechia

Netherlands1 site

  • Prinses Maxima Centrum ( Site 0461)

    Utrecht, 3584 CS

Other trials in Netherlands

Slovakia1 site

  • Narodny ustav detskych chorob ( Site 0372)

    Bratislava, Bratislava Region, 833 40

Other trials in Slovakia

United Kingdom1 site

  • University College London Hospitals NHS Foundation Trust ( Site 0454)

    London, London, City of, NW1 2PG

Other trials in United Kingdom

About this study

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)

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.

Read the detailed description

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.

Being tested
pembrolizumab, doxorubicin, vinblastine, dacarbazine, cyclophosphamide
Keywords
Programmed Death-1 (PD-1), PD1, Programmed Death-Ligand 1 (PD-L1), PDL1
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pembrolizumabBiological

    Also called MK-3475

    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

  • doxorubicinDrug

    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)

  • vinblastineDrug

    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)

  • dacarbazineDrug

    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)

  • cyclophosphamideDrug

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

  • vincristineDrug

    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/prednisoloneDrug

    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)

  • bleomycinDrug

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

  • etoposideDrug

    Also called Etoposide Phosphate

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

  • Radiotherapy (RT)Radiation

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

Study groups in NCT03407144
Study groupRoleWhat they receive
Pembrolizumab + AVD (Group 1)ExperimentalAfter 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.
Receives: Biological: pembrolizumab; Drug: doxorubicin; Drug: vinblastine; Drug: dacarbazine; Drug: bleomycin; Radiation: Radiotherapy (RT)
Pembrolizumab + COPDAC-28 (Group 2)ExperimentalAfter 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.
Receives: Biological: pembrolizumab; Drug: doxorubicin; Drug: dacarbazine; Drug: cyclophosphamide; Drug: vincristine; Drug: prednisone/prednisolone; Drug: etoposide; Radiation: Radiotherapy (RT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)

    ORR is defined as the percentage of SER participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) using IWG revised response criteria and determined by BICR. The ORR will be estimated by risk group in SER participants.

    Measured: Up to approximately 8 years

Secondary outcomes (9)

  1. Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy

    The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake ≤ mediastinum, Score 3= Uptake > mediastinum but ≤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.

    Measured: Up to approximately 8 years

  2. Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR

    EFS is defined as the time from first dose to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.

    Measured: Up to approximately 2 years

  3. Overall Survival (OS) in SER Participants By Risk Group (Low, High)

    OS is defined as the time from first dose to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.

    Measured: Up to approximately 2 years

  4. Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)

    The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.

    Measured: Up to approximately 8 years

  5. Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy

    The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction as per investigator assessment. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake ≤ mediastinum, Score 3= Uptake > mediastinum but ≤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.

    Measured: Up to approximately 8 years

  6. EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator

    EFS is defined as the time from first dose to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.

    Measured: Up to approximately 3 years

  7. OS in RER Participants By Risk Group (Low, High)

    OS is defined as the time from first dose to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.

    Measured: Up to approximately 3 years

  8. Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)

    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.

    Measured: Up to approximately 8 years

  9. Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)

    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.

    Measured: Up to approximately 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start9 Apr 2018
  3. Primary completion12 Feb 2027 (estimated)
  4. Study completion12 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03407144
Sponsor's protocol ID
3475-667
Other IDs
MK-3475-667, 2023-504821-38-00, U1111-1289-8373, 2017-001123-53, 2017, 2023
Status last verified
Oct 2026
First submitted
17 Jan 2018
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 37505794

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pembrolizumab, doxorubicin and vinblastine in people with Hodgkin Lymphoma, run by Merck Sharp & Dohme LLC at 93 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, France, Germany, Italy, Colombia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03407144, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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