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)
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
Iowa
University of Iowa-Holden Comprehensive Cancer Center ( Site 0115)
RECRUITING
Iowa City
University of Iowa - Waukee ( Site 0111)
RECRUITING
Waukee
Nevada
Comprehensive Cancer Centers of Nevada ( Site 0114)
RECRUITING
Las Vegas
New York
Clinical Research Alliance ( Site 0101)
RECRUITING
Westbury
Other Locations
Australia
Westmead Hospital ( Site 0901)
COMPLETED
Westmead
Chile
Biocenter ( Site 0203)
RECRUITING
Concepción
IC La Serena Research ( Site 0204)
RECRUITING
La Serena
Bradfordhill-Clinical Area ( Site 0202)
RECRUITING
Santiago
Clínica Inmunocel ( Site 0201)
RECRUITING
Santiago
FALP ( Site 0207)
RECRUITING
Santiago
Germany
Universitaetsklinikum Essen ( Site 1302)
RECRUITING
Essen
Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 0403)
RECRUITING
Mexico City
Centro de Investigacion Clinica de Oaxaca ( Site 0405)
RECRUITING
Oaxaca City
New Zealand
Auckland City Hospital ( Site 1001)
COMPLETED
Auckland
Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0502)
RECRUITING
Gdansk
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0504)
RECRUITING
Gliwice
Pratia MCM Krakow ( Site 0503)
RECRUITING
Krakow
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 0501)
RECRUITING
Warsaw
Republic of Korea
Seoul National University Hospital-Oncology ( Site 1101)
RECRUITING
Seoul
Spain
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 0703)
RECRUITING
L'hospitalet Del Llobregat
Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 0701)
RECRUITING
Madrid
Hospital Universitario de Salamanca ( Site 0702)
RECRUITING
Salamanca
Turkey
Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri ( Site 0802)
RECRUITING
Ankara
Ondokuz Mayıs Universitesi ( Site 0803)
COMPLETED
Samsun
United Kingdom
Glan Clwyd Hospital ( Site 0602)
RECRUITING
Bodelwyddan
University College London Hospital ( Site 0605)
RECRUITING
London
The Christie NHS Foundation Trust ( Site 0603)
RECRUITING
Manchester
Churchill Hospital ( Site 0604)
COMPLETED
Oxford
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date:2024-10-14
Estimated Completion Date:2028-11-08
Participants
Target number of participants:60
Treatments
Experimental: Pembrolizumab Coformulated With Hyaluronidase
Participants with rrCHL and rrPMBCL receive pembrolizumab coformulated with hyaluronidase subcutaneous (SC) injection on Day 1 of each 6-week cycle (Q6W) for up to 18 cycles (approximately 2 years) until documented disease progression per investigator assessment.