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
- Diseases
- Hodgkin lymphoma
- 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
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Westmead Hospital ( Site 0901) Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Biocenter ( Site 0203) Coordinator of this site? Confirm its status | Concepción | Chile | Unknown status |
| IC La Serena Research ( Site 0204) Coordinator of this site? Confirm its status | La Serena | Chile | Unknown status |
| Bradfordhill-Clinical Area ( Site 0202) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Clínica Inmunocel ( Site 0201) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| FALP ( Site 0207) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Glan Clwyd Hospital ( Site 0602) Coordinator of this site? Confirm its status | Bodelwyddan | United Kingdom | Unknown status |
| University College London Hospital ( Site 0605) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust ( Site 0603) Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Churchill Hospital ( Site 0604) Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Seoul National University Hospital-Oncology ( Site 1101) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Health Pharma Professional Research S.A. de C.V: ( Site 0403) Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Centro de Investigacion Clinica de Oaxaca ( Site 0405) Coordinator of this site? Confirm its status | Oaxaca City | Mexico | Unknown status |
| Auckland City Hospital ( Site 1001) Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| University of Iowa-Holden Comprehensive Cancer Center ( Site 0115) Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada ( Site 0114) Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| University of Iowa - Waukee ( Site 0111) Coordinator of this site? Confirm its status | Waukee | United States | Unknown status |
| Clinical Research Alliance ( Site 0101) Coordinator of this site? Confirm its status | Westbury | United States | Unknown status |
| Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Hacettepe Universite Hastaneleri ( Site 0802) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ondokuz Mayıs Universitesi ( Site 0803) Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.