NCT04586244

An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma

An Open-Label, Randomized, Phase 2, Umbrella Study to Investigate the Biological Rational of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.

Detailed description

Participants will be stratified based on Programmed cell Death-Ligand 1 (PD-L1) Combined Positive Score ( CPS) \< 10 and PD-L1 CPS ≥ 10.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	retifanlimab	retifanlimab will be administered via IV over 30 minutes (+ 15 min) on Day 1 of each 28-day cycle, up to 3 cycles,
DRUG	epacadostat	epacadostat will be administered daily twice daily orally up to and including day of surgery.
DRUG	INCAGN02385	INCAGN02385 will be administered via IV over 30 minutes (-5/+10 min) every 2 weeks.
DRUG	INCAGN02390	INCAGN02390 will be administered via IV over 30 minutes (-5/+10 min) every 2 weeks.

Timeline

• Start date: 2022-01-14
• Primary completion: 2024-01-29
• Completion: 2024-01-29
• First posted: 2020-10-14
• Last updated: 2025-10-30
• Results posted: 2025-03-10

Locations

12 sites across 3 countries: United States, France, Italy

Regulatory

• FDA-regulated drug study