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New dosing schedule of immunotherapy shows promise for hard-to-treat lymphomas

NCT ID NCT04875195

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested the drug pembrolizumab (Keytruda) given every 6 weeks to 66 adults whose Hodgkin lymphoma or primary mediastinal large B-cell lymphoma had come back or not responded to prior treatment. The main goal was to see how many patients had their tumors shrink or disappear. Results help determine if this less frequent dosing is effective and convenient.

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

66 people

The number who actually took part.

Started

Jun 2021

Finished

Oct 2025

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: * 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. cHL-Specific Disease Characteristics: * Have relapsed or refractory cHL and: * Have relapsed during their last cHL regimen after receiving at least 2 cycles of therapy or within 12 months after completing the last regimen for cHL. OR * Have received at least ≥1 line of prior multiagent therapy with/without brentuximab vedotin (excluding radiation) or auto-SCT for cHL and have failed to respond to or relapsed after their last line of treatment. * Relapsed Disease: disease progression after achieving an overall response of PR or CR to the most recent therapy. * Refractory Disease: failure to achieve CR or PR to the most recent therapy. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: * Is not a woman of child bearing potential (WOCBP). OR * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), for at least 120 days after the last dose of study intervention. * Submit an evaluable core lymph node biopsy for biomarker analysis from an archival (\>60 days) or newly obtained (within 30 days) core or incisional biopsy at Screening which was not previously irradiated. Note: If no archival tissue is available, 2 new fresh core needle samples are required. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Life expectancy \>3 months. * Adequate organ function. 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 * Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication * Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients * Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority * Has a known history of Hepatitis B (defined as hepatitis B surface antigen (HBsAg) reactive) or known active Hepatitis C virus infection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Almazov National Medical Research Centre ( Site 0807)

    Saint Petersburg, Sankt-Peterburg, 197341, Russia

  • Ankara University Department of Hematology, Clinical Research Unit ( Site 1101)

    Ankara, 06100, Turkey (Türkiye)

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

    Annapolis, Maryland, 21401, United States

  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0507)

    Palermo, Sicily, 90146, Italy

  • CNPE Regional Center of Oncology ( Site 1305)

    Kharkiv, Kharkiv Oblast, 61070, Ukraine

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

    Dijon, Cote-d Or, 21000, France

  • Cross Cancer Institute ( Site 0207)

    Edmonton, Alberta, T6G 1Z2, Canada

  • Ege University Medicine of Faculty ( Site 1105)

    Bornova, İzmir, 35100, Turkey (Türkiye)

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

    Brno, Brno-mesto, 625 00, Czechia

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

    Hradec Králové, 500 05, Czechia

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

    Prague, Praha 10, 100 34, Czechia

  • Fondazione IRCCS Policlinico San Matteo ( Site 0509)

    Pavia, Lombardy, 27100, Italy

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

    Barretos, São Paulo, 14784-400, Brazil

  • Groote Schuur Hospital ( Site 0906)

    Cape Town, Western Cape, 7925, South Africa

  • Gustave Roussy ( Site 0402)

    Villejuif, Île-de-France Region, 94800, France

  • Hospital Erasto Gaertner ( Site 1703)

    Curitiba, Paraná, 81520-060, Brazil

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0503)

    Naples, 80131, Italy

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

    Torrance, California, 90502, United States

  • Moscow City Clinical Hospital S.P. Botkin ( Site 0803)

    Moscow, Moscow, 125284, Russia

  • National Cancer Institute ( Site 1303)

    Kyiv, Kyivska Oblast, 03022, Ukraine

  • Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 0902)

    Centurion, Gauteng, 0044, South Africa

  • Pratia MCM Krakow ( Site 0064)

    Krakow, Lesser Poland Voivodeship, 30-510, Poland

  • Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-Oddzial Hematologii i Transplantacji S

    Poznan, Greater Poland Voivodeship, 61-848, Poland

  • The National Medico-Surgical Center N.I. Pirogov ( Site 0801)

    Moscow, Moscow, 105203, Russia

  • Tulane Medical Center ( Site 0110)

    New Orleans, Louisiana, 70112, United States

  • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0063)

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Wits Clinical Research ( Site 0904)

    Johannesburg, Gauteng, 1864, South Africa

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