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: April 24, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Lymphoma, B-cell

Treatment

Pembrolizumab (+) Berahyaluronidase alfa

Pembrolizumab Coformulated With Hyaluronidase

Clinical Study ID

NCT06504394
3475A-F65
MK-3475A-065
U1111-1302-8349
2024-510969-42
  • 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 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

  • 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: 60
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

    Active - Recruiting

  • Biocenter ( Site 0203)

    Concepcion, Biobio 4070196
    Chile

    Site Not Available

  • Biocenter ( Site 0203)

    Concepcion., Biobio 4070196
    Chile

    Active - Recruiting

  • IC La Serena Research ( Site 0204)

    La Serena., Coquimbo 1700000
    Chile

    Active - Recruiting

  • 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 7500921
    Chile

    Active - Recruiting

  • Universitaetsklinikum Essen ( Site 1302)

    Essen, Nordrhein-Westfalen 45147
    Germany

    Active - Recruiting

  • Seoul National University Hospital-Oncology ( Site 1101)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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

    Ciudad de México, Distrito Federal 03100
    Mexico

    Active - Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 0405)

    Oaxaca, 68020
    Mexico

    Active - Recruiting

  • Auckland City Hospital ( Site 1001)

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • Pratia MCM Krakow ( Site 0503)

    Krakow, Malopolskie 30-727
    Poland

    Active - Recruiting

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

    Warszawa, Mazowieckie 02-781
    Poland

    Active - Recruiting

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

    Gdansk, Pomorskie 80-214
    Poland

    Active - Recruiting

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

    Gliwice, Slaskie 44-102
    Poland

    Active - Recruiting

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

    L'Hospitalet Del Llobregat, Barcelona 08908
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca ( Site 0702)

    Salamanca, Castilla Y Leon 37007
    Spain

    Active - Recruiting

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

    Madrid, 28041
    Spain

    Active - Recruiting

  • Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Hacettepe Universite Hastaneleri ( Site 0802)

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Ondokuz Mayıs Universitesi ( Site 0803)

    Samsun, 55270
    Turkey

    Active - Recruiting

  • Glan Clwyd Hospital ( Site 0602)

    Bodelwyddan, Denbighshire LL18 5UJ
    United Kingdom

    Active - Recruiting

  • University College London Hospital ( Site 0605)

    London, London, City Of NW1 2PG
    United Kingdom

    Active - Recruiting

  • Churchill Hospital ( Site 0604)

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust ( Site 0603)

    Manchester, m20 4bx
    United Kingdom

    Active - Recruiting

  • Clinical Research Alliance ( Site 0101)

    Westbury, New York 11590
    United States

    Active - Recruiting

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