PEMBROLIZUMAB for Advanced-stage classical Hodgkin lymphoma | Classical Hodgkin lymphoma

Inclusion criteria

• {"criterion_text":"- Histologically confirmed first diagnosis of cHL\n- Advanced-stage disease: Stage IIB with one or both of the following risk factors [Large mediastinal mass (≥ 1/3 of the maximum transverse thoracic diameter), Extranodal disease] or Stage III-IV\n- Age at enrollment: 18-60 years\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) ≥ 8 g/dL (without red-blood-cell transfusion within the prior 7 days) • White blood cell (WBC) concentration ≥ 3 x 109/L • Platelet concentration ≥ 100 x 109/L (without platelet transfusion within the prior 7 days) • Absolute neutrophil count (ANC) ≥ 1.0 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 female patient is eligible to participate if she is not pregnant (see 11.1.6), not breastfeeding, and either: a) Not a woman of childbearing potential (WOCBP) as defined in 11.1.6 OR b) A WOCBP who agrees to follow the guidance on contraception and pregnancy testing in section 11.1.6 from enrollment until at least 6 months after the last dose of trial treatment. A male patient must agree to use contraception as detailed in section 11.1.6 of this protocol from enrollment until at least 6 months after the last dose of trial treatment and refrain from donating sperm during this period."}

Exclusion criteria

• {"criterion_text":"- Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma\n- Diagnosis of immunodeficiency or chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of antineoplastic or immunosuppressive therapy within 7 days prior to signing the IC\n- Current or prior participation in a study of an investigational agent or use of investigational device within 4 weeks prior to signing the ICF.\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 except for a corticosteroid pre-phase\n- Chemotherapy, radiotherapy or allogenic stem cell/solid organ transplant in medical history\n- Prior or concurrent disease precluding protocol treatment\n- Abnormal laboratory findings (except for HL-related changes or functional disorders; values must be obtained within 28 days prior to signing the ICF): • Total bilirubin > 1.5 x upper limit of normal (ULN); patients with total bilirubin > 5 mg/dl are not eligible irrespective of cause. • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x ULN • Creatinine clearance or calculated creatinine clearance < 60 mL/minute (24-hour urine or calculation based on Modification of Diet in Renal Disease (MDRD) formula/ Cockroft-Goult formula); patients with creatinine clearance < 10 mL/minute are not eligible irrespective of cause. • Fasting blood sugar > 200 mg/dL • International normalized ratio or activated partial thromboplastin time (aPTT) > 1.5 × ULN\n- Live vaccine within 30 days prior to signing the ICF.\n- Pregnancy, breastfeeding, or expecting to conceive or father children during the treatment period and for at least 6 months after the last dose of trial treatment\n- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, hypersensitivity to pembrolizumab and/ or excipients, or prior therapy with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)\n- Prior therapy with brentuximab vedotin or known hypersensitivity to brentuximab vedotin"}

Primary endpoints

• {"endpoint_text":"- 1-year PFS estimate","definition_or_measurement_approach":"The primary endpoint is the 1-year Progression-free Survival rate after treatment with one dose of pembrolizumab followed by four to six cycles of immunochemotherapy with P-BrECADD and PET-guided radiotherapy as per standard of care."}

Secondary endpoints

• {"endpoint_text":"- Adverse events","definition_or_measurement_approach":""}
• {"endpoint_text":"- Target number of P-BrECADD cycles per 100 participants","definition_or_measurement_approach":""}
• {"endpoint_text":"- Remission status after 1x P (PET-1), 1x P + 2x P-BrECADD (PET-3) and after completion of PET-guided chemo-immunotherapy (PET-5 or PET-7, respectively)","definition_or_measurement_approach":"Assessment of remission status at PET-1, PET-3 and at PET-5 or PET-7 as specified timepoints."}
• {"endpoint_text":"- Overall survival after one year","definition_or_measurement_approach":""}
• {"endpoint_text":"- Patient-reported outcomes (PRO-CTCAE, Fatigue, QLQ-C30 and Quality of Life)","definition_or_measurement_approach":"PRO measures using PRO-CTCAE, fatigue scales, EORTC QLQ-C30 and Quality of Life instruments as listed."}

Germany

Earliest CTIS Part Ii Submission Date

17-09-2025

Latest Decision Or Authorization Date

30-01-2026

Processing Time Days

135

Number Of Sites

10

Number Of Participants

40

Primary sponsor

Full Name

University Of Cologne

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Contract research organisations

Name

KARO – KML Academic Research Organisation GmbH

Responsibilities

code: 1

Name

Almac Group Limited

Responsibilities

Labeling, secondary packaging, final QP certification, shipping

Third parties

• {"country":"Germany","full_name":"KARO – KML Academic Research Organisation GmbH","duties_or_roles":"code: 1","organisation_type":"Health care"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"Labeling, secondary packaging, final QP certification, shipping","organisation_type":"Pharmaceutical company"}