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

Phase 2

Recruiting

• Conditions: Penile Cancer; Penile Squamous Cell Carcinoma; Penile Neoplasms
• Interventions: Drug: Avelumab

• Registration Number: NCT03774901
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-13
• Study Start: 2019-03-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21
• Primary Completion: 2024-09-22
• Study Completion: 2024-09-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
avelumab maintenance	Avelumab	Avelumab will be administered at a dose of 10 mg/kg every 2 weeks with appropriate supportive care

Primary Outcome Measures

Name	Time	Method
PFS (progression-free survival)	24 months	To estimate progression-free survival in patients included in this study

Secondary Outcome Measures

Name	Time	Method
MDT (median duration of treatment)	24 months	To estimate the median duration of avelumab treatment calculated from avelumab initiation in patients included in this study
QOL (quality of life) assessed by EORTC QLQ-C30	24 months	To assess health-related quality of life since avelumab is started in patients included in this study
OS (overall survival)	32 months	To estimate overall survival in patients included in this study
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	24 months	To assess safety profile after avelumab initiation

Trial Locations

Locations (1)

Antoine THIERY VUILLEMIN; 🇫🇷 Besançon, France