Pembro-FLASH

Korábbi kezelés

• 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

Laborértékek

• 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

Egyéb

• 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

• 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.