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Could a simple shot replace IV therapy for tough lymphomas?

NCT ID NCT06504394

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing an injectable form of the immunotherapy drug pembrolizumab (combined with hyaluronidase to help absorption) in 66 adults with classical Hodgkin lymphoma or primary mediastinal large B-cell lymphoma that has returned or not responded to prior treatment. The study aims to see how well the drug works (tumor shrinkage) and how it behaves in the body when given as a shot under the skin. It is not a cure, but a potential way to control the disease with a more convenient injection instead of an IV infusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab with hyaluronidase (MK-3475A)
What this could lead to
If successful, this could offer a more convenient, injectable version of an existing immunotherapy for people with certain lymphomas that have come back or not responded to treatment.
What could go wrong
This is a phase 2 study with only 66 participants, so results are preliminary. The drug may not work as well as the intravenous version, and side effects from immunotherapy can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: 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 * 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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 classic Hodgkin lymphoma primary mediastinal large B-cell lymphoma relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Classical Hodgkin lymphoma recurrent Classical Hodgkin lymphoma refractory Primary mediastinal large B-cell lymphoma-recurrent Primary mediastinal large B-cell lymphoma-refractory

Contacts and locations

Locations

  • Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801)

    Ankara, 06100, Turkey (Türkiye)

  • Auckland City Hospital ( Site 1001)

    Auckland, 1023, New Zealand

  • Biocenter ( Site 0203)

    Concepción, Biobio, 4070196, Chile

  • Bradfordhill-Clinical Area ( Site 0202)

    Santiago, Region M. de Santiago, 8420383, Chile

  • Centro de Investigacion Clinica de Oaxaca ( Site 0405)

    Oaxaca City, 68020, Mexico

  • Churchill Hospital ( Site 0604)

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

  • Clinical Research Alliance ( Site 0101)

    Westbury, New York, 11590, United States

  • Clínica Inmunocel ( Site 0201)

    Santiago, Region M. de Santiago, 7580206, Chile

  • Comprehensive Cancer Centers of Nevada ( Site 0114)

    Las Vegas, Nevada, 89169, United States

  • FALP ( Site 0207)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Glan Clwyd Hospital ( Site 0602)

    Bodelwyddan, Denbighshire, LL18 5UJ, United Kingdom

  • Hacettepe Universite Hastaneleri ( Site 0802)

    Ankara, 06230, Turkey (Türkiye)

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

    Mexico City, Mexico City, 03100, Mexico

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

    Madrid, 28041, Spain

  • Hospital Universitario de Salamanca ( Site 0702)

    Salamanca, Castille and León, 37007, Spain

  • IC La Serena Research ( Site 0204)

    La Serena, Coquimbo Region, 1720430, Chile

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

    L'Hospitalet Del Llobregat, Barcelona, 08908, Spain

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

    Gliwice, Silesian Voivodeship, 44-102, Poland

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

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Ondokuz Mayıs Universitesi ( Site 0803)

    Samsun, 55270, Turkey (Türkiye)

  • Pratia MCM Krakow ( Site 0503)

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Seoul National University Hospital-Oncology ( Site 1101)

    Seoul, 03080, South Korea

  • The Christie NHS Foundation Trust ( Site 0603)

    Manchester, m20 4bx, United Kingdom

  • Universitaetsklinikum Essen ( Site 1302)

    Essen, North Rhine-Westphalia, 45147, Germany

  • University College London Hospital ( Site 0605)

    London, London, City of, NW1 2PG, United Kingdom

  • University of Iowa - Waukee ( Site 0111)

    Waukee, Iowa, 50263, United States

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

    Iowa City, Iowa, 52242, United States

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

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Westmead Hospital ( Site 0901)

    Westmead, New South Wales, 2145, Australia

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