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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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 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)

NCT04875195•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have a histologically confirmed diagnosis of cHL or PMBCL, according to the World Health Organization (WHO) classification \[Swerdlow, S. H., et al 2008\].
•Has radiographically measurable cHL or PMBCL disease as per Lugano classification with at least 1 nodal lesion (which has not been previously radiated) that is \>15 mm in long axis, regardless of the length of the short axis, and/or extranodal lesion of \>10 mm in long and short axis.
•PMBCL-Specific Disease Characteristics:
•Have relapsed or refractory PMBCL and:
•Have relapsed after auto-stem cell transplant (SCT) or have failed to achieve a CR or PR within 60 days of auto-SCT. Participants may have received intervening therapy after auto-SCT for relapsed or refractory disease, in which case they must have relapsed after or be refractory to their last treatment.
•OR
•\- For participants who are ineligible for auto-SCT, have received at least ≥2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. At least 1 of the prior lines of therapy must contain a rituximab-based regimen.
•Note: Participants should not need urgent cytoreductive therapy.
•Relapsed Disease: disease progression after achieving an overall response of PR or CR in response to the most recent therapy
•Refractory Disease: failure to achieve CR or PR to the most recent therapy.
+14 more criteria

Exclusion Criteria

•Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic SCT within the last 5 years
•Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
•Has pericardial effusion or clinically significant pleural effusion
•Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers
•Is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) \<3 days prior to the first dose of study intervention. Note: Participants who receive daily steroid replacement therapy are an exception
•Has 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 event (AEs) due to agents administered more than 4 weeks earlier
•Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
•Has received prior chimeric antigen receptor T-cell (CAR-T) therapy
•Has received prior systemic anticancer therapy, or radiotherapy, including investigational agents within 4 weeks prior to the first dose of study intervention. Note: If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
•Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities, and not require corticosteroids
+10 more criteria

Locations (27)

Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site

Torrance, California, United States

Tulane Medical Center ( Site 0110)

New Orleans, Louisiana, United States

Anne Arundel Medical Center-Anne Arundel Oncology and Hematology ( Site 0125)

Annapolis, Maryland, United States

Hospital Erasto Gaertner ( Site 1703)

Curitiba, Paraná, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1701)

Barretos, São Paulo, Brazil

Cross Cancer Institute ( Site 0207)

Edmonton, Alberta, Canada

Fakultni nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0302)

Brno, Brno-mesto, Czechia

Fakultni nemocnice Kralovske Vinohrady-Interni hematologicka klinika ( Site 0303)

Prague, Praha 10, Czechia

Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0304)

Hradec Králové, Czechia

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 0401)

Dijon, Cote-d Or, France

Key Dates

Start Date

June 7, 2021

Primary Completion Date

December 14, 2023

Completion Date

October 13, 2025

Last Updated

October 29, 2025

Enrollment

ACTUAL participants

Conditions

Hodgkin's LymphomaPrimary Mediastinal Large B-cell Lymphoma (PMBCL)

Interventions

Pembrolizumab

BIOLOGICAL

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

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RECRUITINGPHASE1

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

NCT06667687

Non-Hodgkin's Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

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