NCT04863885

Combination of Ipi/Nivo Plus Sacituzumab Govitecan in Metastatic Cisplatin Ineligible Urothelial Carcinoma Patients

Phase I/II Study of Ipilimumab Plus Nivolumab (IPI-NIVO) Combined With Sacituzumab Govitecan (SG)as First-line Treatment for Cisplatin-ineligible Metastatic Urothelial Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see how well the study drugs called Ipilimumab plus Nivolumab (IPI-NIVO) work when added to another study drug called Sacituzumab Govitecan for people who have metastatic bladder cancer.

Detailed description

The phase I component of this study will evaluate fixed doses of ipilimumab and nivolumab (3 mg/kg and 1 mg/kg, respectively) IV every 3 weeks x 4 cycles combined with a starting dose of sacituzumab govitecan Level 1 of 8 mg/kg IV days 1,8 every 3 weeks (1 cycle) x 4 cycles. One dose escalation to 10 mg/kg and one dose reduction to dose level minus 1 of sacituzumab govitecan 6 mg/kg days 1,8 every 3 weeks is allowed. The phase II component will be conducted as two-stage trial enrolling 34 patients with a futility interim analysis after stage 1 (13 patients). After 4 cycles, patients will continue maintenance nivolumab 360 mg IV every Q 21 days along with RP2 dose of SG D1,8 Q21 days till progression of disease or intolerable toxicities or patient decision. Radiographic imaging is performed every 12 weeks to assess response.

Conditions

• Metastatic Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Ipilimumab	Participants will receive Ipilimumab 3 mg/kg
DRUG	Nivolumab	Participants will receive Nivoumab 1mg/kg
DRUG	Sacituzumab govitecan	Participants will be treated at 1 of 2 dose levels of Sacituzumab govitecan, either at 8 mg/kg, 10 mg/kg, or 6 mg/kg.

Timeline

• Start date: 2021-04-30
• Primary completion: 2025-09-12
• Completion: 2027-10-01
• First posted: 2021-04-28
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study