Tests a new drug regimen first for advanced Hodgkin lymphoma

Trial details

Who runs it

University Of Cologne

Trial code

NCT06045159EU 2022-501458-13-01

Record updated

12 March 2026

Original description

The primary objective of this trial is to estimate efficacy of the novel regimen. 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.Read full original descriptionShow less

Pembro-FLASH - Phase II trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classic Hodgkin Lymphoma

The primary objective of this trial is to estimate efficacy of the novel regimen. 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.

Inclusion: Histologically confirmed first diagnosis of cHL; 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; Age at enrollment: 18-60 years; Participants must be willing and capable of giving written informed consent prior to any trial-related activity; 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; 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; Estimated life expectancy > 3 months; 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: 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; Current or prior participation in a study of an investigational agent or use of investigational device within 4 weeks prior to signing the ICF; 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; Prior cHL-directed treatment except for a corticosteroid pre-phase; Chemotherapy, radiotherapy or allogenic stem cell/solid organ transplant in medical history; Prior or concurrent disease precluding protocol treatment; Live vaccine within 30 days prior to signing the ICF; 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); Prior therapy with brentuximab vedotin or known hypersensitivity to brentuximab vedotin; Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma; 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; Lack of accountability and inability to appreciate the nature, meaning and consequences of the trial and to formulate their own wishes correspondingly; Relationship of dependence or employer-employee relationship to the sponsor or the investigator; Committal to an institution on judicial or official order; 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.

ClinicalTrials.gov NCT06045159 · EU CTIS 2022-501458-13-01