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

NCT03774901 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-04-21

No results posted yet for this study

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.

Conditions

  • Penile Cancer
  • Penile Neoplasms
  • Penile Squamous Cell Carcinoma

Interventions

DRUG

Avelumab

intravenous 10 mg/kg every 2 weeks

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2024-09-22
Completion
2024-09-22

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03774901 on ClinicalTrials.gov