Maintenance Avelumab Immunotherapy in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma

Key Eligibility Criteria Inclusion: * Histologically confirmed unresectable locally advanced or metastatic squamous cell penile carcinoma * Patients who have received a minimum of 3 and a maximum of 6 cycles of polychemotherapy including a platinum (cisplatin or carboplatin) administered as 1st line systemic treatment. In the event of pretreatment with cisplatin: a cumulative minimum dose of 210 mg/m2 is required in order to be eligible. In the event of pretreatment with carboplatin: a minimum cumulative dose equivalent to 3 cycles of carboplatin AUC5 is required to be eligible * Patients without disease-progression according to the RECIST v1.1 criteria (i.e. in complete or partial response or stable disease at inclusion) after 3 to 6 cycles of 1st line chemotherapy. * ECOG (Eastern Cooperative Group) performance status of 0 to 2 * Adequate organ function: Absolute neutrophil (N) count ≥ 1500/mm3 ou ≥ 1,5.10\^9/L Platelets ≥ 100 000 / mm3 Haemoglobin ≥ 9 g/dL Creatinine clearance ≥ 30 mL/min (by the MDRD formula) Total bilirubin ≤ 1.5 x ULN (upper limit of the normal range) AST ≤ 2.5 x ULN and ALT ≤ 2.5 x ULN OR AST and ALT ≤ 5 x ULN if liver abnormalities due to liver metastases AST = aspartate aminotransferase ALT = alanine aminotransferase Exclusion: * Patients who have never received chemotherapy with a platinum (cisplatin or carboplatin) * Patients who have received more than one previous line of systemic treatment for penile cancer unless in case of more than 12…