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Evaluating Pembrolizumab with Berahyaluronidase for Lymphoma Treatment

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)

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT06504394

This study is testing a new treatment that combines pembrolizumab and berahyaluronidase to see if it helps adults with certain types of lymphoma that haven't responded to other therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation, pembrolizumab
Locations26 sites (Westbury, New York and 25 other locations)
Trial IDNCT06504394 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of pembrolizumab coformulated with berahyaluronidase alfa in adults with relapsed or refractory classical Hodgkin lymphoma or primary mediastinal large B-cell lymphoma. The primary focus is on assessing the pharmacokinetics of the treatment following subcutaneous injection and determining the objective response rate in participants. The study does not have a formal hypothesis to test, but aims to gather important data on the treatment's effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults with a confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma or primary mediastinal large B-cell lymphoma.

Not a fit: Patients with non-Hodgkin lymphoma or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat lymphoma types.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Westbury, New York and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Classical Hodgkin Lymphoma RecurrentClassical Hodgkin Lymphoma RefractoryPrimary Mediastinal Large B-cell Lymphoma RecurrentPrimary Mediastinal Large B-cell Lymphoma RefractoryProgrammed Cell Death-1Programmed Death-Ligand 1Programmed Cell Death-2Programmed Death-Ligand 2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.