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A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
Trial Status: active
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.
Inclusion Criteria
Inclusion Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of locally advanced/unresectable
or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.
- Arm A: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease
progression while on treatment or after treatment with an anti-PD-1/L1 monoclonal
antibody (mAb) for locally advanced/unresectable or mUC administered either as
monotherapy, or in combination with other checkpoint inhibitors or other therapies
OR disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb
for muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy.
- Arm A: Participants must provide an archival tumor tissue sample or newly obtained
core or excisional biopsy of a tumor lesion demonstrating UC, not previously
irradiated, and adequate for biomarker evaluation.
- Arm B: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease
progression after treatment with an anti-PD-1/L1 mAb for locally
advanced/unresectable or mUC administered either as monotherapy, or in combination
with other checkpoint inhibitors or other therapies; OR disease recurrence after
treatment with an anti-PD-1/L1 mAb for MIUC administered as monotherapy or in
combination with other checkpoint therapies >12 months after last dose of treatment
with an anti-PD-1/L1 mAb.
- Arm B: Participants must provide an archival tumor tissue sample or newly obtained
core or excisional biopsy of a tumor lesion from a metastatic site or from a primary
tumor that has become locally advanced and not previously irradiated.
Exclusion Criteria:
- Known additional nonurothelial malignancy that is progressing or has required active
treatment within 3 years prior to study randomization/allocation.
- Received prior systemic anticancer therapy including investigational agents within 4
weeks before randomization/allocation.
- Active infection requiring systemic therapy.
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines are allowed.
- Known history of human immunodeficiency virus (HIV).
- Known history of hepatitis B or known hepatitis C virus infection.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05562830.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center