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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Incyte Corporation
Study ID
NCT04586244
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 14, 2022
Status verified
Oct 2025
Primary completion
Jan 29, 2024
Completion
Jan 29, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group A
    epacadostat will be administered in combination with retifanlimab.
  • Experimental: Treatment Group B
    retifanlimab will be administered as monotherapy.
  • Experimental: Treatment Group C
    epacadostat will be administered as monotherapy.
  • Experimental: Treatment Group D
    retifanlimab will be administered in combination with INCAGN02385.
  • Experimental: Treatment Group E
    retifanlimab will be administered in combination with INCAGN02385 and INCAGN02390.

Primary Outcome Measure

Change From Baseline in CD8+ Lymphocytes Within the Resected Tumor [ Time Frame: up to 69 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-
University of CincinnatiCincinnatiOhio45267-
Ohio State University Medical Center Division of HColumbusOhio43210-
Oregon Health & Science UniversityPortlandOregon97239-4501-

Find similar trials in Iowa City, IA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Iowa· Iowa City, IAUniversity of Cincinnati· Cincinnati, OHOhio State University Medical Center Division of H· Columbus, OHOregon Health & Science University· Portland, OR

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