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

PHASE2TerminatedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 14, 2022

Primary Completion Date

January 29, 2024

Study Completion Date

January 29, 2024

Conditions
Urothelial Carcinoma
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.

Trial Locations (12)

20132

Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele, Milan

37124

Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma), Verona

40138

L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi, Bologna

43210

Ohio State University Medical Center Division of H, Columbus

45267

University of Cincinnati, Cincinnati

52242

University of Iowa, Iowa City

70124

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari

75015

Hopital Europeen Georges Pompidou (Hegp), Paris

75475

Hospital Saint Louis, Paris

94805

Institut Gustave Roussy, Villejuif

97239-4501

Oregon Health & Science University, Portland

00128

Universita Campus Bio Medico Di Roma, Roma

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY

NCT04586244 - An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma | Biotech Hunter | Biotech Hunter