Klinische Studie

DEfeating PEnile CAncer 1 - Phase II study to evaluate a first-line systemic therapy with enfortumab vedotin plus avelumab for advanced and metastatic penile carcinoma(DEPECA-1)A Phase II study to evaluate a first-line systemic therapy with enfortumab vedotin plus avelumab for advanced and metastatic penile carcinoma
Krankheitsentität(en) Sonstige Tumoren
StudientypInterventionsstudiePhase II
Wesentliche Einschlusskriterien1. Male patients with histologically confirmed diagnosis of penile squamous cell carcinoma. 2. Patients must be considered non-eligible for curative surgical management. Eligibility for trial inclusion should be based on the presence of either distant metastatic disease (M1) or at least one of the following scenarios based on the UICC/AJCC 8th edition TNM clinical and pathological classification of penile cancer: a. Stage 3 (cT3) disease with a single lymph node involved (N1). b. Stage 4 disease (cT4). c. Any T stage with either N2 (involvement of multiple or bilateral inguinal nodes) or N3 (fixed inguinal nodal mass or pelvic lymphadenopathy) disease. Patients without distant metastases are eligible if multidisciplinary team review concludes that they are unsuitable for curative surgery. 3. Tumor material (archival or current) is available for local pathology testing (PD-L1, HPV). 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 5. Measurable disease per RECIST 1.1. criteria.
Wesentliche Ausschlusskriterien1. Previous systemic therapy for metastatic or locally advanced PeCa in the palliative setting. 2. Previous treatment with investigational drugs or devices within 30 days prior to the first dose of trial treatment. 3. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 4. Active, known, or suspected autoimmune disease requiring systemic treatment within the past 2 years. Patients with controlled autoimmune disease not requiring systemic immunosuppressive treatment including diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases are eligible. 5. Has ongoing sensory or motor neuropathy Grade 2 or higher.
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de
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