NCT02845323

Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder

Randomized Phase II Study of Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the post cystectomy CD8+ tumor response of patients receiving Nivolumab plus Urelumab versus Nivolumab alone. Half the patients will receive Nivolumab plus Urelumab, while the other half will receive Nivolumab alone.

Detailed description

This is phase II clinical trial design randomizing patients who are cisplatin-ineligible or chemotherapy-refusing with MIBC (stages T2-T4, N0-N2, M0) to one of two treatment arms: Arm A - Nivolumab in combination with Urelumab or Arm B - Nivolumab monotherapy. The study population will include male and female patients over the age of 18 with muscle invasive urothelial carcinoma of the bladder (MIBC) who are not suitable for cisplatin-based chemotherapy or refuse chemotherapy, but are fit to undergo surgical resection of their cancer by cystectomy. Patients with resectable clinical node positive disease within the true pelvis are eligible.

Conditions

• Urothelial Carcinoma
• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab in combination with Urelumab	Two cycles of Nivolumab Two cycles of Urelumab
DRUG	Nivolumab monotherapy	Two cycles of Nivolumab alone

Timeline

• Start date: 2017-05-16
• Primary completion: 2027-07-31
• Completion: 2027-12-01
• First posted: 2016-07-27
• Last updated: 2026-04-06

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study