A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)

Last updated: February 6, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

2

Condition

Lymphoma, B-cell

Lymphoma

Treatment

Pembrolizumab (+) Berahyaluronidase alfa

Pembrolizumab Coformulated With Hyaluronidase

Clinical Study ID

NCT06504394
3475A-F65
MK-3475A-065
U1111-1302-8349
2024-510969-42
2024-510969-42-00
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of the study is to assess the pharmacokinetics (PK) profile of pembrolizumab following subcutaneous (SC) injection of pembrolizumab coformulated with hyaluronidase, and to evaluate the objective response rate (ORR) of pembrolizumab (+) berahyaluronidase alfa SC in adult participants with Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL). There is no formal hypothesis to be tested for this study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) or primarymediastinal B-cell lymphoma (PMBCL)

  • Radiographically measurable cHL or PMBCL disease assessed by investigator as perLugano classification

  • Have a life expectancy of >3 months

  • Human immunodeficiency virus (HIV)-infected participants must have well controlledHIV on antiretroviral therapy (ART)

  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks,and have undetectable HBV viral load before enrollment

  • Participants with history of hepatitis C virus (HCV) infection are eligible if theyhave completed curative antiviral therapy at least 4 weeks before enrollment and HCVviral load is undetectable at screening

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1assessed within 7 days before or on the day of the first dose of study intervention

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has clinically significant (i.e., active) cardiovascular disease

  • Has pericardial effusion or clinically significant pleural effusion

  • Has known additional malignancy that is progressing or has required active treatmentwithin the past 2 years

  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any otherform of immunosuppressive therapy within 7 days prior to the first dose of studyintervention

  • Received prior monoclonal antibody within 4 weeks prior to first dose of studyintervention or has not recovered (i.e., ≤Grade 1 or at baseline) from adverseevents (AEs) due to agents administered more than 4 weeks earlier

  • Received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1),anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell deathligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory orcoinhibitory T-cell receptor

  • Received prior systemic anticancer therapy including investigational agents within 4weeks before the first dose of study intervention

  • Received prior radiotherapy within 2 weeks of start of study intervention, or hasradiation-related toxicities, requiring corticosteroids

  • Received a live or live-attenuated vaccine within 30 days before first dose of studyintervention

  • Is receiving systemic antineoplastic chemotherapy, immunotherapy, or biologicaltherapy not specified in this protocol

  • Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis

  • Active autoimmune disease that has required systemic treatment in the past 2 years

  • History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease

  • Active infection requiring systemic therapy except certain protocol-specifiedtherapies

  • Concurrent active hepatitis B and hepatitis C virus infection

  • Has undergone solid organ transplant at any time, or prior allogeneic hematopoieticstem cell transplant (SCT) within the last 5 years

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: Pembrolizumab (+) Berahyaluronidase alfa
Phase: 2
Study Start date:
October 14, 2024
Estimated Completion Date:
November 08, 2028

Connect with a study center

  • Westmead Hospital ( Site 0901)

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Westmead Hospital ( Site 0901)

    Westmead 2143973, New South Wales 2155400 2145
    Australia

    Site Not Available

  • Biocenter ( Site 0203)

    Concepcion, Biobio 4070196
    Chile

    Site Not Available

  • Biocenter ( Site 0203)

    Concepcion., Biobio 4070196
    Chile

    Site Not Available

  • IC La Serena Research ( Site 0204)

    La Serena., Coquimbo 1700000
    Chile

    Site Not Available

  • IC La Serena Research ( Site 0204)

    La Serena 3884373, Coquimbo Region 3893623 1720430
    Chile

    Site Not Available

  • Bradfordhill-Clinical Area ( Site 0202)

    Santiago, Region M. De Santiago 8420383
    Chile

    Active - Recruiting

  • Clínica Inmunocel ( Site 0201)

    Santiago, Region M. De Santiago 7580206
    Chile

    Active - Recruiting

  • FALP ( Site 0207)

    Santiago, Region M. De Santiago 7500994
    Chile

    Site Not Available

  • Bradfordhill-Clinical Area ( Site 0202)

    Santiago 3871336, Region M. de Santiago 8420383
    Chile

    Site Not Available

  • Clínica Inmunocel ( Site 0201)

    Santiago 3871336, Region M. de Santiago 7580206
    Chile

    Site Not Available

  • FALP ( Site 0207)

    Santiago 3871336, Region M. de Santiago 7500921
    Chile

    Site Not Available

  • Biocenter ( Site 0203)

    Concepción 3893894, Región del Biobío 3898380 4070196
    Chile

    Site Not Available

  • Universitaetsklinikum Essen ( Site 1302)

    Essen, Nordrhein-Westfalen 45147
    Germany

    Site Not Available

  • Universitaetsklinikum Essen ( Site 1302)

    Essen 2928810, North Rhine-Westphalia 2861876 45147
    Germany

    Site Not Available

  • Seoul National University Hospital-Oncology ( Site 1101)

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Health Pharma Professional Research S.A. de C.V: ( Site 0403)

    Ciudad de México, Distrito Federal 03100
    Mexico

    Site Not Available

  • Health Pharma Professional Research S.A. de C.V: ( Site 0403)

    Mexico City 3530597, Mexico City 3527646 03100
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica de Oaxaca ( Site 0405)

    Oaxaca, 68020
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica de Oaxaca ( Site 0405)

    Oaxaca City 3522507, 68020
    Mexico

    Site Not Available

  • Auckland City Hospital ( Site 1001)

    Auckland, 1023
    New Zealand

    Site Not Available

  • Auckland City Hospital ( Site 1001)

    Auckland 2193733, 1023
    New Zealand

    Site Not Available

  • Pratia MCM Krakow ( Site 0503)

    Krakow 3094802, Lesser Poland Voivodeship 858786 30-727
    Poland

    Site Not Available

  • Pratia MCM Krakow ( Site 0503)

    Krakow, Malopolskie 30-727
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 0501)

    Warsaw 756135, Masovian Voivodeship 858787 02-781
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site

    Warszawa, Mazowieckie 02-781
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 0501)

    Warszawa, Mazowieckie 02-781
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0502)

    Gdansk 3099434, Pomeranian Voivodeship 3337496 80-214
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0502)

    Gdansk, Pomorskie 80-214
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0504)

    Gliwice 3099230, Silesian Voivodeship 3337497 44-102
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0504)

    Gliwice, Slaskie 44-102
    Poland

    Site Not Available

  • Seoul National University Hospital-Oncology ( Site 1101)

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 0703)

    L'Hospitalet Del Llobregat, Barcelona 08908
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca ( Site 0702)

    Salamanca, Castilla Y Leon 37007
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca ( Site 0702)

    Salamanca 3111108, Castille and León 3336900 37007
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 0701)

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 0701)

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Hacettepe Universite Hastaneleri ( Site 0802)

    Ankara, 06230
    Turkey

    Site Not Available

  • Ondokuz Mayıs Universitesi ( Site 0803)

    Samsun, 55270
    Turkey

    Site Not Available

  • Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)

    Ankara 323786, 06100
    Turkey (Türkiye)

    Site Not Available

  • Hacettepe Universite Hastaneleri ( Site 0802)

    Ankara 323786, 06230
    Turkey (Türkiye)

    Site Not Available

  • Ondokuz Mayıs Universitesi ( Site 0803)

    Samsun 740264, 55270
    Turkey (Türkiye)

    Site Not Available

  • Glan Clwyd Hospital ( Site 0602)

    Bodelwyddan, Denbighshire LL18 5UJ
    United Kingdom

    Site Not Available

  • Glan Clwyd Hospital ( Site 0602)

    Bodelwyddan 2655283, Denbighshire LL18 5UJ
    United Kingdom

    Site Not Available

  • University College London Hospital ( Site 0605)

    London, London, City Of NW1 2PG
    United Kingdom

    Site Not Available

  • University College London Hospital ( Site 0605)

    London 2643743, London, City of NW1 2PG
    United Kingdom

    Site Not Available

  • Churchill Hospital ( Site 0604)

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Site Not Available

  • Churchill Hospital ( Site 0604)

    Oxford 2640729, Oxfordshire OX3 7LE
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust ( Site 0603)

    Manchester, m20 4bx
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust ( Site 0603)

    Manchester 2643123, m20 4bx
    United Kingdom

    Site Not Available

  • University of Iowa-Holden Comprehensive Cancer Center ( Site 0115)

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • University of Iowa - Waukee ( Site 0111)

    Waukee 4880981, Iowa 4862182 50263
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada ( Site 0114)

    Las Vegas 5506956, Nevada 5509151 89169
    United States

    Site Not Available

  • Clinical Research Alliance ( Site 0101)

    Westbury, New York 11590
    United States

    Site Not Available

  • Clinical Research Alliance ( Site 0101)

    Westbury 5144040, New York 5128638 11590
    United States

    Site Not Available

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