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)
- Conditions
- Classical Hodgkin Lymphoma RecurrentClassical Hodgkin Lymphoma RefractoryPrimary Mediastinal Large B-cell Lymphoma RecurrentPrimary Mediastinal Large B-cell Lymphoma Refractory
- Registration Number
- NCT06504394
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>The main inclusion criteria include but are not limited to the following:<br><br> - Histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) or primary<br> mediastinal B-cell lymphoma (PMBCL)<br><br> - Radiographically measurable cHL or PMBCL disease assessed by investigator as per<br> Lugano classification<br><br> - Have a life expectancy of >3 months<br><br> - Human immunodeficiency virus (HIV)-infected participants must have well controlled<br> HIV on antiretroviral therapy (ART)<br><br> - Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if<br> they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks,<br> and have undetectable HBV viral load before enrollment<br><br> - Participants with history of hepatitis C virus (HCV) infection are eligible if they<br> have completed curative antiviral therapy at least 4 weeks before enrollment and HCV<br> viral load is undetectable at screening<br><br> - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1<br> assessed within 7 days before first dose of study intervention<br><br>Exclusion Criteria:<br><br>The main exclusion criteria include but are not limited to the following:<br><br> - Has clinically significant (i.e., active) cardiovascular disease<br><br> - Has pericardial effusion or clinically significant pleural effusion<br><br> - Has known additional malignancy that is progressing or has required active treatment<br> within the past 2 years<br><br> - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other<br> form of immunosuppressive therapy within 7 days prior to the first dose of study<br> intervention<br><br> - Received prior monoclonal antibody within 4 weeks prior to first dose of study<br> intervention or has not recovered (i.e., =Grade 1 or at baseline) from adverse<br> events (AEs) due to agents administered more than 4 weeks earlier<br><br> - Received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1),<br> anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death<br> ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or<br> coinhibitory T-cell receptor<br><br> - Received prior systemic anticancer therapy including investigational agents within 4<br> weeks before the first dose of study intervention<br><br> - Received prior radiotherapy within 2 weeks of start of study intervention, or has<br> radiation-related toxicities, requiring corticosteroids<br><br> - Received a live or live-attenuated vaccine within 30 days before first dose of study<br> intervention<br><br> - Is receiving systemic antineoplastic chemotherapy, immunotherapy, or biological<br> therapy not specified in this protocol<br><br> - Has known active central nervous system (CNS) metastases and/or carcinomatous<br> meningitis<br><br> - Active autoimmune disease that has required systemic treatment in the past 2 years<br><br> - History of (noninfectious) pneumonitis/interstitial lung disease that required<br> steroids or has current pneumonitis/interstitial lung disease<br><br> - Active infection requiring systemic therapy<br><br> - Concurrent active hepatitis B and hepatitis C virus infection<br><br> - Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic<br> stem cell transplant (SCT) within the last 5 years
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) per Lugano Classification Criteria as Assessed by Investigator;Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase;Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase;Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks)
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) per Lugano Classification Criteria as Assessed by Investigator;Number of Participants with Antidrug Antibodies (ADA) Level of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase;Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady State;Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady State;Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks) at Steady State;Number of Participants Experiencing an Adverse Event (AE);Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)