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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)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: A Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2024-10-14
Completion Date
2028-11-08
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab (+) Berahyaluronidase alfa
SC injection
Locations (29)
University of Iowa-Holden Comprehensive Cancer Center ( Site 0115)
Iowa City, Iowa, United States
University of Iowa - Waukee ( Site 0111)
Waukee, Iowa, United States
Comprehensive Cancer Centers of Nevada ( Site 0114)
Las Vegas, Nevada, United States
Clinical Research Alliance ( Site 0101)
Westbury, New York, United States
Westmead Hospital ( Site 0901)
Westmead, New South Wales, Australia
IC La Serena Research ( Site 0204)
La Serena, Coquimbo Region, Chile
FALP ( Site 0207)
Santiago, Region M. de Santiago, Chile
Clínica Inmunocel ( Site 0201)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0202)
Santiago, Region M. de Santiago, Chile
Biocenter ( Site 0203)
Concepción, Región del Biobío, Chile
Universitaetsklinikum Essen ( Site 1302)
Essen, North Rhine-Westphalia, Germany
Health Pharma Professional Research S.A. de C.V: ( Site 0403)
Mexico City, Mexico City, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0405)
Oaxaca City, Mexico
Auckland City Hospital ( Site 1001)
Auckland, New Zealand
Pratia MCM Krakow ( Site 0503)
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 0501)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0502)
Gdansk, Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0504)
Gliwice, Silesian Voivodeship, Poland
Seoul National University Hospital-Oncology ( Site 1101)
Seoul, South Korea
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 0703)
L'Hospitalet Del Llobregat, Barcelona, Spain
Hospital Universitario de Salamanca ( Site 0702)
Salamanca, Castille and León, Spain
Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 0701)
Madrid, Spain
Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)
Ankara, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 0802)
Ankara, Turkey (Türkiye)
Ondokuz Mayıs Universitesi ( Site 0803)
Samsun, Turkey (Türkiye)
Glan Clwyd Hospital ( Site 0602)
Bodelwyddan, Denbighshire, United Kingdom
University College London Hospital ( Site 0605)
London, London, City of, United Kingdom
Churchill Hospital ( Site 0604)
Oxford, Oxfordshire, United Kingdom
The Christie NHS Foundation Trust ( Site 0603)
Manchester, United Kingdom