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Trial Title: 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)

NCT ID: NCT06504394

Condition: Classical Hodgkin Lymphoma Recurrent
Classical Hodgkin Lymphoma Refractory
Primary Mediastinal Large B-cell Lymphoma Recurrent
Primary Mediastinal Large B-cell Lymphoma Refractory

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Hodgkin Disease
Recurrence
Pembrolizumab

Conditions: Keywords:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Programmed Cell Death-2 (PD2, PD-2)
Programmed Death-Ligand 2 (PDL2, PD-L2)

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Pembrolizumab Coformulated With Hyaluronidase
Description: SC injection
Arm group label: Pembrolizumab Coformulated With Hyaluronidase

Other name: MK-3475A

Summary: The primary purpose of the study is to assess the pharmacokinetics (PK) profile of pembrolizumab (MK-3475) following subcutaneous (SC) injection of pembrolizumab coformulated with hyaluronidase (MK-3475A), and to evaluate the objective response rate (ORR) of MK-3475A 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 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 first dose of study intervention Exclusion Criteria: The main exclusion criteria include but are not limited to the following: - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Clinical Research Alliance ( Site 0101)

Address:
City: Westbury
Zip: 11590
Country: United States

Status: Recruiting