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Classical Hodgkin Lymphoma RecurrentPhase 2NCT06504394

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 testing Pembrolizumab (+) Berahyaluronidase alfa in people with Classical Hodgkin Lymphoma Recurrent and Classical Hodgkin Lymphoma Refractory, run by Merck Sharp & Dohme LLC at 29 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab (+) Berahyaluronidase alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
29 sitesin 11 countries
Study dates
14 Oct 2024to 8 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 or on the day of the first dose of study intervention

Who cannot join

  • 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
Show all 17Show fewer
  • 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 except certain protocol-specified therapies
  • 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

Trial locations and contacts

29 sites in 11 countries.

29 sites in 11 countries

Chile5 sites

  • Biocenter ( Site 0203)

    Concepción, Biobio, 4070196

  • IC La Serena Research ( Site 0204)

    La Serena, Coquimbo Region, 1720430

  • FALP ( Site 0207)

    Santiago, Region M. de Santiago, 7500921

  • Clínica Inmunocel ( Site 0201)

    Santiago, Region M. de Santiago, 7580206

  • Bradfordhill-Clinical Area ( Site 0202)

    Santiago, Region M. de Santiago, 8420383

Other trials in Chile

United States4 sites

  • University of Iowa-Holden Comprehensive Cancer Center ( Site 0115)

    Iowa City, Iowa, 52242

  • Comprehensive Cancer Centers of Nevada ( Site 0114)

    Las Vegas, Nevada, 89169

  • University of Iowa - Waukee ( Site 0111)

    Waukee, Iowa, 50263

  • Clinical Research Alliance ( Site 0101)

    Westbury, New York, 11590

Other trials in United States

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0502)

    Gdansk, Pomeranian Voivodeship, 80-214

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0504)

    Gliwice, Silesian Voivodeship, 44-102

  • Pratia MCM Krakow ( Site 0503)

    Krakow, Lesser Poland Voivodeship, 30-727

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 0501)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

United Kingdom4 sites

  • Glan Clwyd Hospital ( Site 0602)

    Bodelwyddan, Denbighshire, LL18 5UJ

  • University College London Hospital ( Site 0605)

    London, London, City of, NW1 2PG

  • The Christie NHS Foundation Trust ( Site 0603)

    Manchester, m20 4bx

  • Churchill Hospital ( Site 0604)

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

Spain3 sites

  • Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 0703)

    L'Hospitalet Del Llobregat, Barcelona, 08908

  • Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 0701)

    Madrid, 28041

  • Hospital Universitario de Salamanca ( Site 0702)

    Salamanca, Castille and León, 37007

Other trials in Spain

Turkey (Türkiye)3 sites

  • Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)

    Ankara, 06100

  • Hacettepe Universite Hastaneleri ( Site 0802)

    Ankara, 06230

  • Ondokuz Mayıs Universitesi ( Site 0803)

    Samsun, 55270

Other trials in Turkey (Türkiye)

Mexico2 sites

  • Health Pharma Professional Research S.A. de C.V: ( Site 0403)

    Mexico City, Mexico City, 03100

  • Centro de Investigacion Clinica de Oaxaca ( Site 0405)

    Oaxaca City, 68020

Other trials in Mexico

Australia1 site

  • Westmead Hospital ( Site 0901)

    Westmead, New South Wales, 2145

Other trials in Australia

Germany1 site

  • Universitaetsklinikum Essen ( Site 1302)

    Essen, North Rhine-Westphalia, 45147

Other trials in Germany

New Zealand1 site

  • Auckland City Hospital ( Site 1001)

    Auckland, 1023

Other trials in New Zealand

South Korea1 site

  • Seoul National University Hospital-Oncology ( Site 1101)

    Seoul, 03080

Other trials in South Korea

About this study

Official title: 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)

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.

Being tested
Pembrolizumab (+) Berahyaluronidase alfa
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Cell Death-2 (PD2, PD-2), Programmed Death-Ligand 2 (PDL2, PD-L2)
Medical subject headings
Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab (+) Berahyaluronidase alfaBiological

    Also called MK-3475A

    SC injection

Study groups in NCT06504394
Study groupRoleWhat they receive
Pembrolizumab Coformulated With HyaluronidaseExperimentalParticipants with rrCHL and rrPMBCL receive pembrolizumab coformulated with hyaluronidase subcutaneous (SC) injection on Day 1 of each 6-week cycle (Q6W) for up to 18 cycles (approximately 2 years) until documented disease progression per investigator assessment.
Receives: Biological: Pembrolizumab (+) Berahyaluronidase alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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 transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). The percentage of participants who experience CR or PR as assessed by investigator will be presented.

    Measured: Up to approximately 48 months

  2. Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase

    Blood samples will be collected at designated timepoints for the determination of Cmax. Cmax is defined as the peak concentration of pembrolizumab after administration of SC pembrolizumab coformulated with hyaluronidase.

    Measured: At designated time points (up to ~6 weeks)

  3. Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase

    Blood samples will be collected at designated timepoints for the determination of Ctrough. Ctrough is defined as the lowest concentration of pembrolizumab after administration of SC pembrolizumab coformulated with hyaluronidase.

    Measured: At designated time points (up to ~6 weeks)

  4. Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks)

    Blood samples will be collected at designated timepoints for the determination of AUC0-6weeks. AUC0-6 weeks is defined as area under concentration time curve over a 6-week dosing interval of pembrolizumab after administration of SC pembrolizumab coformulated with hyaluronidase.

    Measured: At designated time points (up to ~6 weeks)

Secondary outcomes (7)

  1. Duration of Response (DOR) per Lugano Classification Criteria as Assessed by Investigator

    For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response was evaluated based on the 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 transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR as assessed by the investigator will be presented.

    Measured: Up to approximately 48 months

  2. Number of Participants with Antidrug Antibodies (ADA) Level of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase

    Blood samples will be collected at designated time points for the determination of the presence or absence of ADA of pembrolizumab after administration of SC pembrolizumab coformulated with hyaluronidase. The number of participants who develop ADA will be reported.

    Measured: At designated timepoints (Up to approximately 27 months)

  3. Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady-State

    Blood samples will be collected at designated timepoints for the determination of Cmax. Cmax is defined as the peak concentration of pembrolizumab after administration of SC pembrolizumab coformulated with hyaluronidase at steady-state.

    Measured: At designated time points (up to ~6 weeks)

  4. Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady-State

    Blood samples will be collected at designated timepoints for the determination of Ctrough. Ctrough is defined as the lowest concentration of pembrolizumab after administration of SC pembrolizumab coformulated with hyaluronidase at steady-state.

    Measured: At designated time points (up to ~6 weeks)

  5. Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks) at Steady-State

    Blood samples will be collected at designated timepoints for the determination of AUC0-6weeks. AUC0-6 weeks is defined as area under concentration time curve over a 6-week dosing interval of pembrolizumab coformulated with hyaluronidase at steady-state.

    Measured: At designated time points (up to ~6 weeks)

  6. Number of Participants Experiencing an Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 30 months

  7. Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2024
  2. Study start14 Oct 2024
  3. Primary completion8 Nov 2028 (estimated)
  4. Study completion8 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06504394
Sponsor's protocol ID
3475A-F65
Other IDs
MK-3475A-065, 2024-510969-42-00, U1111-1302-8349
Status last verified
Feb 2026
First submitted
11 Jul 2024
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab (+) Berahyaluronidase alfa in people with Classical Hodgkin Lymphoma Recurrent and Classical Hodgkin Lymphoma Refractory, run by Merck Sharp & Dohme LLC at 29 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Chile, United States, Poland, United Kingdom, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) per Lugano Classification Criteria as Assessed by Investigator (time frame: Up to approximately 48 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06504394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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