Last updated 16 days ago
A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) 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)(MK-3475A-F65)
60 patients around the world
Available in Chile
Merck Sharp & Dohme LLC
2Research sites
60Patients around the world
This study is for people with
Lymphoma
Hodgkin lymphoma
Non-Hodgkin Lymphoma
Primary mediastinal large B-cell lymphoma
Classic Hodgkin lymphoma (cHL)
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 first dose of study intervention.
- 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.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.
Sites
IC La Serena Research - La Serena
Recruiting
Inmunocel
Recruiting
SponsorMerck Sharp & Dohme LLC
Conditions
Hodgkin lymphomaPrimary mediastinal large B-cell lymphomaClassic Hodgkin lymphoma (cHL)
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06504394
