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NCT06504394Active, not recruitingPhase 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)

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)

Source: ClinicalTrials.gov · Last updated 9 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
66 (estimated)
First submitted
11 Jul 2024
Start date
14 Oct 2024
Primary completion date
8 Nov 2028
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT06504394
EU CT number
2024-510969-42-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 66
  • From 14 Oct 2024 to the primary completion date, 8 Nov 2028
  • 28 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Has clinically significant (i.e., active) cardiovascular disease
  • Has known additional malignancy that is progressing or has required active treatment within the past 2 years
  • 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

Other

  • The main exclusion criteria include but are not limited to the following:
  • Has pericardial effusion or clinically significant pleural effusion
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Westmead Hospital ( Site 0901)
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WestmeadAustraliaUnknown status
Biocenter ( Site 0203)
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ConcepciónChileUnknown status
IC La Serena Research ( Site 0204)
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La SerenaChileUnknown status
Bradfordhill-Clinical Area ( Site 0202)
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SantiagoChileUnknown status
Clínica Inmunocel ( Site 0201)
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SantiagoChileUnknown status
FALP ( Site 0207)
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SantiagoChileUnknown status
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Glan Clwyd Hospital ( Site 0602)
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BodelwyddanUnited KingdomUnknown status
University College London Hospital ( Site 0605)
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LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust ( Site 0603)
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ManchesterUnited KingdomUnknown status
Churchill Hospital ( Site 0604)
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OxfordUnited KingdomUnknown status
Seoul National University Hospital-Oncology ( Site 1101)
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SeoulSouth KoreaUnknown status
Health Pharma Professional Research S.A. de C.V: ( Site 0403)
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Mexico CityMexicoUnknown status
Centro de Investigacion Clinica de Oaxaca ( Site 0405)
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Oaxaca CityMexicoUnknown status
Auckland City Hospital ( Site 1001)
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AucklandNew ZealandUnknown status
Pratia S.A.
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CracowPolandActive, not recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
University of Iowa-Holden Comprehensive Cancer Center ( Site 0115)
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Iowa CityUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada ( Site 0114)
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Las VegasUnited StatesUnknown status
University of Iowa - Waukee ( Site 0111)
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WaukeeUnited StatesUnknown status
Clinical Research Alliance ( Site 0101)
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WestburyUnited StatesUnknown status
Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)
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AnkaraTurkey (Türkiye)Unknown status
Hacettepe Universite Hastaneleri ( Site 0802)
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AnkaraTurkey (Türkiye)Unknown status
Ondokuz Mayıs Universitesi ( Site 0803)
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SamsunTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.