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NCT06504394 · ClinicalTrials.gov registry record · Phase 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 of Primary Mediastinal Large B-Cell Lymphoma Recurrent and Primary Mediastinal Large B-Cell Lymphoma Refractory, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT06504394: Active Phase 2 study of Primary Mediastinal Large B-Cell Lymphoma Recurrent and Primary Mediastinal Large B-Cell Lymphoma Refractory, sponsored by Merck Sharp & Dohme.
NCT06504394 is a Phase 2 study of Primary Mediastinal Large B-Cell Lymphoma Recurrent and Primary Mediastinal Large B-Cell Lymphoma Refractory that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06504394, a Phase 2 study of Primary Mediastinal Large B-Cell Lymphoma Recurrent and Primary Mediastinal Large B-Cell Lymphoma Refractory, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response was assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transv
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab (+) Berahyaluronidase alfa
Study Locations (20)
Region M. de Santiago
- FALP ( Site 0207) - Santiago
- Clínica Inmunocel ( Site 0201) - Santiago
- Bradfordhill-Clinical Area ( Site 0202) - Santiago
Other
- Centro de Investigacion Clinica de Oaxaca ( Site 0405) - Oaxaca City
- Auckland City Hospital ( Site 1001) - Auckland
- Seoul National University Hospital-Oncology ( Site 1101) - Seoul
Iowa
- University of Iowa-Holden Comprehensive Cancer Center ( Site 0115) - Iowa City
- University of Iowa - Waukee ( Site 0111) - Waukee
Nevada
- Comprehensive Cancer Centers of Nevada ( Site 0114) - Las Vegas
New York
- Clinical Research Alliance ( Site 0101) - Westbury
New South Wales
- Westmead Hospital ( Site 0901) - Westmead
Coquimbo Region
- IC La Serena Research ( Site 0204) - La Serena
Región del Biobío
- Biocenter ( Site 0203) - Concepción
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2024-10-14 |
| Est. Completion | 2028-11-08 |
| Phase | Phase 2 |
What the registry record for NCT06504394 still lists
NCT06504394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 4 conditions, with Primary Mediastinal Large B-Cell Lymphoma Recurrent appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab (+) Berahyaluronidase alfa is the first listed.
NCT06504394 names 20 study sites across 15 states, led by Region M. de Santiago, Other, Iowa.
Frequently Asked Questions
What is clinical trial NCT06504394 about?
NCT06504394 is a clinical study titled "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)". 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 participa...
What is the current status of trial NCT06504394?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2024-10-14. Estimated completion is 2028-11-08.
What conditions does trial NCT06504394 study?
This clinical trial studies the following conditions: Primary Mediastinal Large B-Cell Lymphoma Recurrent, Primary Mediastinal Large B-Cell Lymphoma Refractory, Classical Hodgkin Lymphoma Recurrent, Classical Hodgkin Lymphoma Refractory.
What interventions are being tested in trial NCT06504394?
The interventions under investigation include: Pembrolizumab (+) Berahyaluronidase alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT06504394?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06504394 being conducted?
This trial has 20 study locations across Iowa, Nevada, New York, New South Wales, Coquimbo Region. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06504394's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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