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NCT04875195 · ClinicalTrials.gov registry record · Phase 2
A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68)
A Phase 2 study of Hodgkin's Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL), sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT04875195: Completed Phase 2 study of Hodgkin's Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL), sponsored by Merck Sharp & Dohme.
NCT04875195 is a Phase 2 study of Hodgkin's Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL) that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 66 participants, below the 101-participant average among 18 other Hodgkin's Lymphoma trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04875195, a Phase 2 study of Hodgkin's Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL), has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab every six weeks (Q6W).
Primary Outcome
ORR was defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose- positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decr
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
Study Locations (20)
Other
- Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0304) - Hradec Králové
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0503) - Naples
Moscow
- The National Medico-Surgical Center N.I. Pirogov ( Site 0801) - Moscow
- Moscow City Clinical Hospital S.P. Botkin ( Site 0803) - Moscow
California
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site - Torrance
Louisiana
- Tulane Medical Center ( Site 0110) - New Orleans
Maryland
- Anne Arundel Medical Center-Anne Arundel Oncology and Hematology ( Site 0125) - Annapolis
Paraná
- Hospital Erasto Gaertner ( Site 1703) - Curitiba
São Paulo
- Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1701) - Barretos
Alberta
- Cross Cancer Institute ( Site 0207) - Edmonton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2025-10-13 |
| Phase | Phase 2 |
What the finished NCT04875195 record still lists
NCT04875195 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 101-participant average among 18 other Hodgkin's Lymphoma trials with a reported enrollment target (35% lower).
The record links to 2 conditions, with Hodgkin's Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT04875195 names 20 study sites across 18 states, led by Other, Moscow, California.
Frequently Asked Questions
What is clinical trial NCT04875195 about?
NCT04875195 is a clinical study titled "A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68)". The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab every six weeks (Q6W).
What is the current status of trial NCT04875195?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2021-06-07. Estimated completion is 2025-10-13.
What conditions does trial NCT04875195 study?
This clinical trial studies the following conditions: Hodgkin's Lymphoma, Primary Mediastinal Large B-cell Lymphoma (PMBCL).
What interventions are being tested in trial NCT04875195?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04875195?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04875195 being conducted?
This trial has 20 study locations across California, Louisiana, Maryland, Paraná, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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