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

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.

Timeline

Start

2022-01-14

Primary completion

2024-01-29

Completion

2024-01-29

Outcome

Missed primary endpoint

Stopped (Business): “Business Decision. No safety concerns contributed to this decision.”

registry analysis (superiority test); Retifanlimab 500 mg Q4W; p = 0.0925; paired t-test NCT04586244 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Epacadostat	Small molecule	—	Oral
Subject	Retifanlimab	Monoclonal antibody	—	Intravenous
Subject	Tuparstobart	Monoclonal antibody	—	Intravenous
Subject	Verzistobart	Monoclonal antibody	—	Intravenous

Indications