This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Administered via intravenous (IV) infusion on day 1 and day 8 of Q3W cycles
Administered via IV infusion on Day 1 of each 6 week cycle.
Administered as an IV infusion on Day 1, Day 15, and Day 29 of each 6 week cycle.
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045)
Orange, California, United States
RECRUITINGUniversity of California San Francisco ( Site 1044)
San Francisco, California, United States
RECRUITINGAnschutz Cancer Pavilion ( Site 1017)
Aurora, Colorado, United States
COMPLETEDUniversity of Chicago Medical Center ( Site 1037)
Chicago, Illinois, United States
Percentage of Participants Who Experienced At Least One Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 5 years
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment
Time frame: Up to approximately 5 years
Arm A: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants who achieve a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 2 years
Arm B: ORR as Assessed by Investigator
ORR is defined as the percentage of participants who achieve a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Time frame: Up to approximately 2 years
Arm A: Duration of Response (DOR) as Assessed by BICR
For participants who demonstrate confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 2 years
Arm B: DOR as Assessed by Investigator
For participants who demonstrate confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indiana University Melvin and Bren Simon Cancer Center ( Site 1011)
Indianapolis, Indiana, United States
RECRUITINGSiteman Cancer Center ( Site 1038)
St Louis, Missouri, United States
RECRUITINGMemorial Sloan Kettering Cancer Center ( Site 1031)
New York, New York, United States
RECRUITINGCleveland Clinic-Taussig Cancer Center ( Site 1036)
Cleveland, Ohio, United States
RECRUITINGUPMC Hillman Cancer Center ( Site 1014)
Pittsburgh, Pennsylvania, United States
RECRUITINGHuntsman Cancer Institute ( Site 1041)
Salt Lake City, Utah, United States
RECRUITING...and 18 more locations