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ACTIVE NOT RECRUITING
NCT06504394
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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