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.
Participants will be stratified based on Programmed cell Death-Ligand 1 (PD-L1) Combined Positive Score ( CPS) \< 10 and PD-L1 CPS ≥ 10.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
retifanlimab will be administered via IV over 30 minutes (+ 15 min) on Day 1 of each 28-day cycle, up to 3 cycles,
epacadostat will be administered daily twice daily orally up to and including day of surgery.
INCAGN02385 will be administered via IV over 30 minutes (-5/+10 min) every 2 weeks.
University of Iowa
Iowa City, Iowa, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University Medical Center Division of H
Columbus, Ohio, United States
Change From Baseline in CD8+ Lymphocytes Within the Resected Tumor
Fold Change from Baseline in CD8+ lymphocytes = CD8+ Lymphocytes at cystectomy divided by CD8+ lymphocytes at Screening. Translational data in all but the retifanlimab 500 mg Q4W treatment group were limited and insufficient to assess this outcome measure.
Time frame: up to 69 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Time frame: up to 159 days
Number of Participants With Any ≥Grade 3 TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Time frame: up to 159 days
Pathological Complete Response Rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
INCAGN02390 will be administered via IV over 30 minutes (-5/+10 min) every 2 weeks.
Oregon Health & Science University
Portland, Oregon, United States
Hopital Europeen Georges Pompidou (Hegp)
Paris, France
Hospital Saint Louis
Paris, France
Institut Gustave Roussy
Villejuif, France
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari, Italy
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Bologna, Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan, Italy
...and 2 more locations
Pathological complete response rate was defined as the percentage of participants with ypT0N0.
Time frame: up to 69 days
Major Pathological Response
Major pathological response was defined as the percentage of participants with residual ypT0/1/a/isN0M0.
Time frame: up to 69 days