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Immunotherapy combo aims to boost hodgkin lymphoma response in slow responders

NCT ID NCT03407144

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding the immunotherapy drug pembrolizumab to standard chemotherapy can help children and young adults (ages 3-25) with newly diagnosed classical Hodgkin lymphoma who did not respond well to initial chemo. About 340 participants will receive pembrolizumab alongside chemo drugs like doxorubicin and vinblastine. The main goal is to see how many achieve a complete or partial response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab (an immunotherapy drug that helps the immune system fight cancer)
What this could lead to
If successful, this could offer a more effective treatment option for children and young adults with Hodgkin lymphoma who do not respond well to standard chemotherapy alone.
What could go wrong
This is a phase 2 trial, so it is still early. The combination may not improve outcomes and could cause additional side effects like immune-related reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2018

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

classic Hodgkin lymphoma Hodgkins lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hodgkin lymphoma

Contacts and locations

Locations

  • Albert Alberts Stem Cell Transplant Centre ( Site 0324)

    Pretoria, Gauteng, 0044, South Africa

  • Alliance for Childhood Diseases ( Site 0064)

    Las Vegas, Nevada, 89135, United States

  • Arkansas Children's Hospital ( Site 0046)

    Little Rock, Arkansas, 72202, United States

  • Arnold Palmer Hospital ( Site 0065)

    Orlando, Florida, 32806, United States

  • Athens Childrens Hospital Aglaia Kyriakou ( Site 0361)

    Athens, Attica, 115 27, Greece

  • Azienda Ospedaliera Santobono - Pausilipon ( Site 0402)

    Naples, 80123, Italy

  • CHU de Bordeaux. Hopital Pellegrin ( Site 0447)

    Bordeaux, Gironde, 33000, France

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

    Marseille, Bouches-du-Rhone, 13005, France

  • Centro di Riferimento Oncologico CRO ( Site 0404)

    Aviano, Pordenone, 33081, Italy

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

    Berlin, 13353, Germany

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

    Atlanta, Georgia, 30322, United States

  • Children's Hospital - Colorado ( Site 0028)

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Alabama ( Site 0023)

    Birmingham, Alabama, 35233, United States

  • Children's Hospital of Michigan ( Site 0056)

    Detroit, Michigan, 48201, United States

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

    Minneapolis, Minnesota, 55404, United States

  • Children's Medical Center ( Site 0030)

    Dallas, Texas, 75235, United States

  • Children's National Medical Center ( Site 0090)

    Washington D.C., District of Columbia, 20010, United States

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

    Cincinnati, Ohio, 45229, United States

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

    New Hyde Park, New York, 11040, United States

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

    New York, New York, 10032, United States

  • Connecticut Children's Medical Center ( Site 0045)

    Hartford, Connecticut, 06106, United States

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

    Austin, Texas, 78723, United States

  • Fakultni nemocnice v Motole ( Site 0356)

    Prague, 150 06, Czechia

  • Hackensack University Medical Center ( Site 0026)

    Hackensack, New Jersey, 07601, United States

  • Hematologica Alta Especialidad ( Site 0532)

    Huixquilucan, 52787, Mexico

  • Hopital Universitaire Robert Debre ( Site 0446)

    Paris, 75019, France

  • Hopital d'Enfants Armand Trousseau ( Site 0443)

    Paris, 75012, France

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

    Curitiba, Paraná, 81520-060, Brazil

  • Hospital Infantil Universitario Nino Jesus ( Site 0433)

    Madrid, 28009, Spain

  • Hospital Infantil de Mexico Federico Gomez ( Site 0535)

    Mexico City, Mexico City, 06720, Mexico

  • Hospital Pablo Tobon Uribe-Hematology ( Site 0565)

    Medellín, Antioquia, 05034, Colombia

  • Hospital Universitari Vall d Hebron ( Site 0432)

    Barcelona, 08035, Spain

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

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital Universitario La Paz ( Site 0434)

    Madrid, 28046, Spain

  • Hôpital Jeanne de Flandre ( Site 0450)

    Lille, Nord, 59037, France

  • IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0400)

    Roma, 00165, Italy

  • Inova Fairfax Hospital ( Site 0031)

    Falls Church, Virginia, 22042, United States

  • Institut Gustave Roussy ( Site 0445)

    Villejuif, Val-de-Marne, 94800, France

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

    Lyon, Auvergne-Rhône-Alpes, 69008, France

  • Instituto Nacional De Cancerologia ( Site 0566)

    Bogotá, Bogota D.C., 111511, Colombia

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

    São Paulo, 04023-062, Brazil

  • Johns Hopkins University ( Site 0025)

    Baltimore, Maryland, 21287, United States

  • Kaiser - Fontana ( Site 0083)

    Fontana, California, 92335, United States

  • Kaiser - Orange County ( Site 0084)

    Anaheim, California, 92806, United States

  • Kaiser Permanente ( Site 0082)

    Downey, California, 90242, United States

  • Kaiser Permanente - Oakland ( Site 0047)

    Oakland, California, 94611, United States

  • Kaiser Permanente - Roseville ( Site 0080)

    Roseville, California, 95661, United States

  • Kaiser Permanente - Santa Clara ( Site 0079)

    Santa Clara, California, 95051, United States

  • Kaiser Permanente Downey Medical Center ( Site 0024)

    Los Angeles, California, 90027, United States

  • Karmanos Cancer Institute ( Site 0002)

    Detroit, Michigan, 48201, United States

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

    Munich, Bavaria, 80337, Germany

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

    Natal, Rio Grande do Norte, 59075-740, Brazil

  • Medi-K Cayala ( Site 0544)

    Guatemala City, 01016, Guatemala

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

    Hollywood, Florida, 33021, United States

  • Memorial Sloan Kettering Cancer Center ( Site 0060)

    New York, New York, 10065, United States

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

    Long Beach, California, 90806, United States

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

    San Antonio, Texas, 78229, United States

  • Narodny ustav detskych chorob ( Site 0372)

    Bratislava, Bratislava Region, 833 40, Slovakia

  • Nationwide Children's Hospital ( Site 0037)

    Columbus, Ohio, 43205-2696, United States

  • Oncomedica ( Site 0545)

    Guatemala City, 01010, Guatemala

  • Oncomédica S.A.S ( Site 0527)

    Montería, Departamento de Córdoba, 230001, Colombia

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

    Barranquilla, Atlántico, 080020, Colombia

  • Ospedale Infantile Regina Margherita ( Site 0401)

    Torino, 10126, Italy

  • Phoenix Childrens Hospital ( Site 0034)

    Phoenix, Arizona, 85016, United States

  • Prinses Maxima Centrum ( Site 0461)

    Utrecht, 3584 CS, Netherlands

  • Riley Hospital for Children ( Site 0091)

    Indianapolis, Indiana, 46202, United States

  • Roswell Park Cancer Institute ( Site 0040)

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey ( Site 0027)

    New Brunswick, New Jersey, 08901, United States

  • Samsung Medical Center ( Site 0222)

    Seoul, 06351, South Korea

  • Seattle Childrens Hospital ( Site 0022)

    Seattle, Washington, 98105, United States

  • Severance Hospital Yonsei University Health System ( Site 0221)

    Seoul, 03722, South Korea

  • St. Francis Hospital Cancer Center ( Site 0001)

    Greenville, South Carolina, 29607, United States

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

    St Louis, Missouri, 63110, United States

  • Texas Children's Hospital ( Site 0042)

    Houston, Texas, 77030, United States

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

    Azcapotzalco, 02990, Mexico

  • UNC Lineberger Comprehensive Cancer ( Site 0044)

    Chapel Hill, North Carolina, 27514, United States

  • Unidad Nacional de Oncologia Pediatrica ( Site 0542)

    Guatemala City, 01011, Guatemala

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

    Roma, Abruzzo, 00161, Italy

  • Universitaetsklinikum Essen ( Site 0415)

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitaetsklinikum Giessen und Marburg GmbH ( Site 0411)

    Giessen, Hesse, 35392, Germany

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

    London, London, City of, NW1 2PG, United Kingdom

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

    Thessaloniki, Central Macedonia, 546 36, Greece

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

    Athens, Attica, 115 27, Greece

  • University of Chicago ( Site 0066)

    Chicago, Illinois, 60637, United States

  • University of Florida ( Site 0051)

    Gainesville, Florida, 32610, United States

  • University of Kentucky Markey Cancer Center ( Site 0057)

    Lexington, Kentucky, 40536-0293, United States

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

    Louisville, Kentucky, 40202, United States

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

    Münster, North Rhine-Westphalia, 48149, Germany

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

    Nashville, Tennessee, 37232, United States

  • Weill Cornell Medicine ( Site 0032)

    New York, New York, 10065, United States

  • Wits Clinical Research ( Site 0321)

    Soweto, Gauteng, 2193, South Africa

  • Wits Clinical Research ( Site 0323)

    Johannesburg, Gauteng, 2193, South Africa

  • Yale Cancer Center ( Site 0061)

    New Haven, Connecticut, 06510, United States

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