Clinical trial • Phase II • Oncology

Pembrolizumab for Early-stage favorable classical Hodgkin lymphoma

Phase II trial of Pembrolizumab for Early-stage favorable classical Hodgkin lymphoma. 50 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Early-stage favorable classical Hodgkin lymphoma
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-11-2025
First CTIS Authorization Date
10-02-2026

Trial design

Phase II trial across 35 sites in Germany.

Target Sample Size
50

Eligibility

Recruits 50 Vulnerable population selected. Participants must be willing and capable of giving written informed consent prior to any trial-related activity; subject information sheets and informed consent forms are provided for adults (no paediatric/assent process is described)..

Pregnancy Exclusion
Pregnancy or breastfeeding.
Vulnerable Population
Vulnerable population selected. Participants must be willing and capable of giving written informed consent prior to any trial-related activity; subject information sheets and informed consent forms are provided for adults (no paediatric/assent process is described).

Inclusion criteria

  • {"criterion_text":"- Histologically confirmed first diagnosis of cHL\n- Early-stage favorable cHL as assessed by all mandatory imaging examinations as outlined in section 5.1.2.3 of the protocol, i.e.stage I-II without risk factors: Large mediastinal mass; Extranodal involvement; Elevated erythrocyte sedimentation rate (ESR); Involvement of ≥ 3 nodal areas\n- Age ≥ 18 and ≤ 75 years on the day of signing the patient information and informed consent form (ICF)\n- Participants must be willing and capable of giving written informed consent prior to any trial-related activity\n- Adequate blood count (except for cHL-related changes or functional disorders) obtained within 7 days prior to signing the ICF: Hemoglobin (Hb) ≥ 9 g/dL (without red-blood-cell transfusion within the prior 7 days) ; Platelet concentration ≥ 100 x 109/L (without platelet transfusion within the prior 7 days) ; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to signing the ICF\n- Estimated life expectancy > 3 months\n- Contraception a) Females of childbearing potential must have a negative urine or serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test within 7 days prior to signing the ICF, not be breastfeeding and be willing to use a highly effective method of contraception as described below from enrollment to at least 6 months after the last dose of systemic trial treatment; b) Non-sterile males who are sexually active with WOCBP must be willing to use barrier methods such as a condom for effective contraception and refrain from sperm donation from enrollment to at least 6 months after the last dose of systemic trial treatment."}

Exclusion criteria

  • {"criterion_text":"- Target disease exceptions: Knwon central nervous system lymphoma, subjects with nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma\n- Current or prior participation in another interventional trial that could interact with this trial.\n- Lack of accountability and inability to appreciate the nature, meaning, and consequences of the trial and to formulate their own wishes correspondingly.\n- Non-compliance, for reasons including, but not limited to, the following: Drug dependency or substance abuse that would interfere with cooperation with requirements of the trial; Refusal of blood products during treatment; Any similar circumstances that appear to make compliance with any trial procedures impossible\n- Relationship of dependence or employer-employee relationship to the sponsor or the investigator.\n- Committal to an institution on judicial or official order.\n- Prior cHL-directed treatment\n- Prior chemotherapy, RT or allogeneic stem cell/solid organ transplant\n- Prior or concurrent disease precluding protocol treatment\n- Abnormal laboratory test findings: a) Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. Patients who receive an antiviral treatment and have no detectable hepatitis B virus (HBV)-DNA or hepatitis C virus (HCV)-RNA can be included in the trial; b) Serum creatinine > 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) < 30 mL/min measured directly or calculated using the CKD-EPI formula; c) Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 2.5 x ULN. d) Total bilirubin > 1.5 x ULN unless the elevation is due to Gilbert’s syndrome h) International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) > 1.5 x ULN\n- Live vaccine or live-attenuated vaccine within 30 days before signing the ICF. Administration of killed vaccines is allowed.\n- Pregnancy or breastfeeding.\n- History of documented allergic reactions or acute hypersensitivity reaction to antibody treatment.\n- Known hypersensitivity or allergy to any of the excipients in the pembrolizumab formulation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) at 1 year","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Remission status after pembrolizumab therapy and after consolidation Radiotherapy\n- Progression-free survival (PFS) at 2 years\n- Overall survival (OS) at 1 year and at 2 years\n- Adverse events during and after anti-PD-1 therapy\n- Patient-reported outcomes at baseline, during treatment and during follow-up\n- Rate of early discontinuation of trial treatment\n- Rate and types of HL-directed treatment administered in addition to trial treatment\n- Event-free survival (EFS) at 1 year and at 2 years","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
50
Recruitment Window Months
36
Consent Approach
Written informed consent is required from participants prior to any trial activities. Inclusion criteria specify participants must be willing and capable of giving written informed consent. Subject information sheets and informed consent forms for adults are provided (documents available in German and English). No paediatric assent process is described; only adult consent materials are listed.

Geography

Total Number Of Sites
35
Total Number Of Participants
50

Germany

Earliest CTIS Part Ii Submission Date
22-01-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
19
Number Of Sites
35
Number Of Participants
50

Sites

Site Name
Klinikum Chemnitz gGmbH
Department Name
Onkologie
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Onkologie
Contact Person Name
Robert Erdmann
Contact Person Email
r.erdmann@asklepios.com
Site Name
Universitaet Des Saarlandes
Contact Person Name
Lorenz Thurner
Contact Person Email
lorenz.thurner@uks.eu
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Innere Medizin
Contact Person Name
Maike Hefter
Contact Person Email
maike.hefter@mri.tum.de
Site Name
Ortenau Klinikum
Department Name
Medizinische Klinik II, Hämatologie, Onkologie
Contact Person Name
Irmgard Dresel
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Innere Medizin
Contact Person Name
Alexander Grunenberg
Site Name
Onkologische Schwerpunktpraxis Bielefeld
Department Name
Onkologie
Contact Person Name
Hendrik Riesenberg
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Innere Medizin
Contact Person Name
Frank Gert Rücker
Contact Person Email
frank.ruecker@mutterhaus.de
Site Name
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Department Name
Hämatologie/Onkologie
Contact Person Name
Paul La Rosee
Contact Person Email
Paul.LaRosee@sbk-vs.de
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
Onkologie
Contact Person Name
Christian Langer
Site Name
Klinikum Esslingen GmbH
Department Name
Innere Medizin/Hämatologie/Onkologie
Contact Person Name
Swen Weßendorf
Site Name
Goethe University Frankfurt
Department Name
Innere Medizin/Hämatologie
Contact Person Name
Teresa Halbsguth
Contact Person Email
Halbsguth@med.uni-frankfurt.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Onkologie
Contact Person Name
Susanne Ghandili
Contact Person Email
s.ghandili@uke.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Innere Medizin/Hämatologie
Contact Person Name
Maisun Abu Samra
Contact Person Email
Maisun.Abusamra@uk-gm.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Hämatologie/Onkologie
Contact Person Name
Martin Vogelhuber
Contact Person Email
martin.vogelhuber@ukr.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Hämatologie/Onkologie
Contact Person Name
Deborah Katharina Christen
Contact Person Email
dchristen@ukaachen.de
Site Name
Rostock University Medical Center
Department Name
Hämatologie/Onkologie
Contact Person Name
Ulrich Langenkamp
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Innere Medizin
Contact Person Name
Julia Meißner
Site Name
Universitaetsklinikum Essen AöR
Department Name
Hämatologie/Onkologie
Contact Person Name
Bastian von Tresckow
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hämatologie/Onkologie
Contact Person Name
Barbara Ferstl
Contact Person Email
Barbara.ferstl@uk-erlangen.de
Site Name
Vincentius-Diakonissen-Kliniken gAG
Department Name
Onkologie
Contact Person Name
Michael Schatz
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Innere Medizin
Contact Person Name
Matthias Bormann
Site Name
Technische Universitaet Dresden
Department Name
Hämatologie
Contact Person Name
Karolin Trautmann-Grill
Contact Person Email
karolin.trautmann@ukdd.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Hämatologie/Onkologie
Contact Person Name
Karin-Gabriela Schrenk
Contact Person Email
karin.schrenk@med.uni-jena.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Hämatologie/Onkologie
Contact Person Name
Stephan Mathas
Contact Person Email
stephan.mathas@charite.de
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Innere Medizin
Contact Person Name
Miriam Ahlborn
Contact Person Email
m.ahlborn@skbs.de
Site Name
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH
Department Name
Hämatologie/Onkologie
Contact Person Name
Tobias Gaska
Contact Person Email
t.gaska@bk-paderborn.de
Site Name
Klinikum Fulda gAG
Department Name
Onkologie
Contact Person Name
Andreas Richard Dickhut
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Innere Medizin
Contact Person Name
Max Topp
Contact Person Email
Topp_M@ukw.de
Site Name
Universitaet Leipzig
Department Name
Innere Medizin/Hämatologie
Contact Person Name
Vladan Vucinic
Site Name
Kliniken Maria Hilf GmbH Moenchengladbach
Department Name
Innere Medizin
Contact Person Name
Ullrich Graeven
Contact Person Email
ulrich.graeven@mariahilf.de
Site Name
University Hospital Cologne AöR
Department Name
Innere Medizin
Contact Person Name
Dennis Eichenauer
Contact Person Email
dennis.eichenauer@uk-koeln.de
Site Name
Maerkische Kliniken GmbH
Department Name
Hämatologie/Onkologie
Contact Person Name
Monika Schwalenberg
Site Name
Johanniter GmbH
Department Name
Innere Medizin
Contact Person Name
Yon-Dschun Ko
Site Name
Robert Bosch Krankenhaus GmbH
Department Name
Hämatologie/Onkologie
Contact Person Name
Sonja Martin
Contact Person Email
sonja.martin@rbk.de

Sponsor

Primary sponsor

Full Name
University Of Cologne
Organisation Type
Educational Institution
Country Of Registered Address
Germany

Contract research organisations

Name
Almac Clinical Services (Ireland) Limited
Responsibilities
Labeling, Shipping
Name
KARO – KML Academic Research Organisation GmbH

Third parties

  • {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"Labeling, Shipping","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"KARO – KML Academic Research Organisation GmbH","duties_or_roles":"","organisation_type":"Health care"}

Investigational products

Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Marketing authorisation (EU MA number EU/1/15/1024/002)
Maximum Dose
1200 mg
Combination Treatment
Yes

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