retifanlimab for Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bladder Cancerretifanlimab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing different combinations of neoadjuvant treatments for people with bladder cancer who can't or won't have cisplatin therapy.

Eligible Conditions
  • Bladder Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: up to 6 months

up to 3 months
Immunologic intratumoral changes
Major pathological response
pathological complete response
up to 6 months
Number of Treatment Emergent Adverse Events (TEAE)

Trial Safety

Trial Design

5 Treatment Groups

Treatment Group A
1 of 5
Treatment Group C
1 of 5
Treatment Group B
1 of 5
Treatment Group E
1 of 5
Treatment Group D
1 of 5

Experimental Treatment

45 Total Participants · 5 Treatment Groups

Primary Treatment: retifanlimab · No Placebo Group · Phase 2

Treatment Group AExperimental Group · 2 Interventions: retifanlimab, epacadostat · Intervention Types: Drug, Drug
Treatment Group C
Drug
Experimental Group · 1 Intervention: epacadostat · Intervention Types: Drug
Treatment Group B
Drug
Experimental Group · 1 Intervention: retifanlimab · Intervention Types: Drug
Treatment Group EExperimental Group · 3 Interventions: retifanlimab, INCAGN02390, INCAGN02385 · Intervention Types: Drug, Drug, Drug
Treatment Group DExperimental Group · 2 Interventions: retifanlimab, INCAGN02385 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
Not yet FDA approved
INCAGN02390
2018
Completed Phase 1
~40
INCAGN02385
2018
Completed Phase 1
~30
Epacadostat
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months

Who is running the clinical trial?

Incyte CorporationLead Sponsor
315 Previous Clinical Trials
46,530 Total Patients Enrolled
Diane Hershock, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
140 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have transitional cell urothelial carcinoma.
You are eligible for radical cystectomy.
You have a tumor that is biopsied before treatment.
You are willing to avoid pregnancy or fathering children from screening through 100 days in the US and 190 days in Europe after the last dose of study drug.