NCT05219435

Study of NIVOLUMAB/IPILIMUMAB Maintenance in Unresectable Locally Advanced or Metastatic Urothelial Cancer

Phase II Non Randomized Clinical Trial of NIVOLUMAB/IPILIMUMAB Maintenance Following First-line Chemotherapy in Unresectable Locally Advanced or Metastatic Urothelial Cancer.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Spanish Oncology Genito-Urinary Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Immunotherapy has improved clinical outcomes in metastatic urothelial carcinoma (mUC). Second-line treatment after progression to platinum-containing chemotherapy with immune checkpoint inhibitors (ICIs) have antitumor activity in advanced / metastatic UC and provide favorable safety profiles when compared with chemotherapy The study aims to determine if Nivolumab plus Ipilimumab maintenance therapy is effective in delaying disease progression in patients with unresectable locally advanced or metastatic urothelial cancer that did not progress during or following completion of first-line chemotherapy. Vexillum plans to recruit patients that achieve clinical benefit from first-line chemotherapy and may be candidates for maintenance immunotherapy to consolidate this benefit.

Detailed description

All enrolled patients should have received first-line chemotherapy and not progressed. After a treatment-free interval of 3-12 weeks from chemotherapy, patients will receive maintenance therapy with 4 cycles of Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg every three weeks (Q3W)(induction phase) followed by Nivolumab 480 mg every 4 weeks (Q4W)(consolidation phase) until unacceptable toxicity, disease progression (PD), investigator ́s decision, patient's consent withdrawal or death by any cause, whichever occurs first. * Induction phase (Total of 4 cycles Q3W) * Nivolumab at 1 mg/kg by intravenous (IV) infusion on D1 of each cycle. * Ipilimumab at 3 mg/kg by intravenous (IV) infusion on D1 of each cycle. * Consolidation phase (Cycles Q4W) ○ Nivolumab at a fixed dose of 480 mg by intravenous (IV) infusion on D1 of each cycle. The maximum duration of treatment with nivolumab will be 2 years, and patients will discontinue treatment at any time in case of unacceptable toxicity, disease progression (PD), investigator ́s decision, patient's consent withdrawal or death by any cause, whichever occurs first.

Conditions

• Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab at 1 mg/kg by intravenous (IV) infusion on D1 of each cycle. Nivolumab at a fixed dose of 480 mg by intravenous (IV) infusion on D1 of each cycle. The maximum duration of treatment with nivolumab will be 2 years, and patients will discontinue treatment at any time in case of unacceptable toxicity, disease progression (PD), investigator ́s decision, patient's consent withdrawal or death by any cause, whichever occurs first.
DRUG	Ipilimumab	Ipilimumab at 3 mg/kg by intravenous (IV) infusion on D1 of each cycle.

Timeline

• Start date: 2022-07-06
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2022-02-02
• Last updated: 2025-09-24

Locations

12 sites across 1 country: Spain