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

NCT04586244 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-30

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Diane Hershock, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2024-01-29
Completion
2024-01-29
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586244 on ClinicalTrials.gov