Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer
Trial Parameters
Brief Summary
This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis
Eligibility Criteria
Inclusion Criteria: 1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 2. Histologically confirmed diagnosis of squamous cell carcinoma of the penis. 3. Patients have one of the following disease stages: * cTxN2-3 or * cTxN1 in case of central nodal necrosis and/or an irregular nodal border, or node \>3cm, or * Inguinal or pelvic lymph node recurrence that is potentially resectable. Any of the disease stages above, in combination with oligometastatic disease with a maximum of 2 distant metastases is allowed, as long as these metastases can be treated by resection or radiotherapy. This should be established in the multidisciplinary tumor board before enrolment. 4. Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies ar