A Phase 2 Clinical Study to Assess Efficacy of Induction Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer: PRIAM
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
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
• Histologically confirmed diagnosis of squamous cell carcinoma of the penis.
• 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.
• 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 are preferred to archived tissue.
• A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 14 days prior to the first dose of study intervention.
• Have adequate organ function defined as: absolute neutrophil count (ANC) ≥1.5 10e9 /L, platelets ≥100 10e9/L; hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L; creatinine ≤1.5 × ULN OR GFR\>30 ml/min as per Cockcroft-Gault formula in patients with creatinine levels \> 1.5x institutional ULN; total bilirubin 1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN; International normalized ratio (INR), prothrombin time (PT) OR activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. Specimens must be collected within 14 days prior to the start of study intervention.