Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07460245

Maintenance AVElumab After SECond Line Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma

Maintenance AVElumab After SECond Line Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma:AVESEC Trial - AVESEC Study

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
144 (estimated)
Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study represents an innovative opportunity in the treatment of metastatic urothelial carcinoma

Detailed description

Phase II, multicenter, randomized, open-label, efficacy and safety study of maintenance avelumab compared to BSC in advanced or metastatic urothelial carcinoma patients not progressed on second-line platinum-based chemotherapy (carboplatin or cisplatin plus gemcitabine) pretreated with pembrolizumab plus enfortumab vedotin.

Conditions

Interventions

TypeNameDescription
DRUGAvelumab 800 mg flat-dose IVAvelumab 800 mg flat-dose IV every 2 weeks

Timeline

Start date
2026-06-01
Primary completion
2026-06-01
Completion
2030-12-01
First posted
2026-03-10
Last updated
2026-03-10

Locations

19 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT07460245. Inclusion in this directory is not an endorsement.