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A Phase 2 Study of Pembrolizumab (MK-3475) every 6 weeks (Q6W) in Participants with Relapsed or Refractory Classical Hodgkin’s Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510979-38-00
Acronym
MK-3475-B68
Enrollment
28
Registered
2024-07-17
Start date
2021-05-27
Completion date
2025-10-09
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory Classical Hodgkins Lymphoma and relapsed or refractory Primary Mediastinal Large B-cell Lymphoma

Brief summary

Objective Response Rate (ORR) per Lugano Classification as Assessed by Investigator

Detailed description

Objective Response Rate (ORR) per Lugano Classification as Assessed by Blinded Independent Central Review (BICR), Duration of Response (DOR) per Lugano Classification as Assessed by Investigator, Duration of Response (DOR) per Lugano Classification as Assessed by BICR, Area Under the Curve (AUC) of Pembrolizumab, Maximum Serum Concentration (Cmax) of Pembrolizumab, Minimum Serum Concentration (Cmin) of Pembrolizumab, Antidrug Antibody Levels (ADA) for Pembrolizumab, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to AE

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective Response Rate (ORR) per Lugano Classification as Assessed by Investigator—

Secondary

MeasureTime frame
Objective Response Rate (ORR) per Lugano Classification as Assessed by Blinded Independent Central Review (BICR), Duration of Response (DOR) per Lugano Classification as Assessed by Investigator, Duration of Response (DOR) per Lugano Classification as Assessed by BICR, Area Under the Curve (AUC) of Pembrolizumab, Maximum Serum Concentration (Cmax) of Pembrolizumab, Minimum Serum Concentration (Cmin) of Pembrolizumab, Antidrug Antibody Levels (ADA) for Pembrolizumab, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to AE—

Countries

Czechia, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026