Maintenance Avelumab Immunotherapy in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma
Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
Patients with unresectable locally advanced or metastatic squamous cell penile carcinoma
(SPC) who are in response or with stable disease after first line platinum containing
polychemotherapy who meet the inclusion/exclusion criteria will be offered to take part in
the study.
The patients may be pre-screened at the time of the 1st line chemotherapy.
In order for patients to be enrolled, the investigator must have carried out a radiological
assessment of the disease during first line systemic treatment (a maximum of between 3 and 6
cycles): the cancer must be controlled. Patients with disease progression cannot be included
in the PULSE study as this is a maintenance study.
After inclusion, Avelumab will be administered at a dose of 10 mg/kg, at a frequency of once
every 2 weeks with appropriate supportive care.