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Clinical Trials in the UK / NCT06504394
Active, not recruiting Phase 2

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)

NCT06504394 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2024-10-14
Last updated
2026-02-09

Condition(s) studied

Classical Hodgkin Lymphoma RecurrentClassical Hodgkin Lymphoma RefractoryPrimary Mediastinal Large B-cell Lymphoma RecurrentPrimary Mediastinal Large B-cell Lymphoma Refractory

Investigational drug(s) / intervention(s)

Pembrolizumab (+) Berahyaluronidase alfa

Pembrolizumab (+) Berahyaluronidase alfa: SC injection

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) * Radiographically measurable cHL or PMBCL disease assessed by investigator as per Lugano classification * Have a life expectancy of \>3 months * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they 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 they have completed curative antiviral therapy at least 4 weeks before enrollment and HCV viral load is undetectable at screening * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before or on the day of the first dose of study intervention 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 treatment within the past 2 years * Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Received prior monoclonal antibody within 4 weeks prior to first dose of study intervention or has not recovered (i.e., ≤Grade 1 or at baseline) from adverse events (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 death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Received a live or live-attenuated vaccine within 30 days before first dose of study intervention * Is receiving systemic antineoplastic chemotherapy, immunotherapy, or biological therapy not specified in this protocol * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease that has required systemic treatment in the past 2 years * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Active infection requiring systemic therapy except certain protocol-specified therapies * Concurrent active hepatitis B and hepatitis C virus infection * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplant (SCT) within the last 5 years

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
University of Iowa-Holden Comprehensive Cancer Center ( Site 0115) Iowa City Iowa
University of Iowa - Waukee ( Site 0111) Waukee Iowa
Comprehensive Cancer Centers of Nevada ( Site 0114) Las Vegas Nevada
Clinical Research Alliance ( Site 0101) Westbury New York
Westmead Hospital ( Site 0901) Westmead New South Wales
Biocenter ( Site 0203) Concepción Biobio
IC La Serena Research ( Site 0204) La Serena Coquimbo Region
FALP ( Site 0207) Santiago Region M. de Santiago
Clínica Inmunocel ( Site 0201) Santiago Region M. de Santiago
Bradfordhill-Clinical Area ( Site 0202) Santiago Region M. de Santiago
Universitaetsklinikum Essen ( Site 1302) Essen North Rhine-Westphalia
Health Pharma Professional Research S.A. de C.V: ( Site 0403) Mexico City Mexico City
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
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 0501) Warsaw Masovian Voivodeship
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0502) Gdansk Pomeranian Voivodeship
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0504) Gliwice Silesian Voivodeship
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
Hospital Universitario de Salamanca ( Site 0702) Salamanca Castille and León
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
University College London Hospital ( Site 0605) London London, City of
Churchill Hospital ( Site 0604) Oxford Oxfordshire
The Christie NHS Foundation Trust ( Site 0603) Manchester United Kingdom

More Merck Sharp & Dohme LLC trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06504394 on ClinicalTrials.gov ↗ ← All trials in the UK