NCT lookup

Inclusion Criteria:

* Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
* Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis.
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have adequate organ function.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

Exclusion Criteria:

* Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions.
* Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
* Has ≥N2 disease or metastatic disease (M1) as identified by imaging.
* Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol.
* Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder.
* Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC.
* Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection.
* Has a known psychiatric or substance abuse disorder.
* Has had an allogenic tissue/solid organ transplant.

• La Jolla, California, United States
• Santa Monica, California, United States
• Washington D.C., District of Columbia, United States
• Orlando, Florida, United States
• Fort Wayne, Indiana, United States
• Indianapolis, Indiana, United States
• New Orleans, Louisiana, United States
• Scarborough, Maine, United States
• Worcester, Massachusetts, United States
• Detroit, Michigan, United States
• St Louis, Missouri, United States
• Morristown, New Jersey, United States
• Albuquerque, New Mexico, United States
• New York, New York, United States
• Cleveland, Ohio, United States
• Tulsa, Oklahoma, United States
• Portland, Oregon, United States
• Pittsburgh, Pennsylvania, United States
• Houston, Texas, United States
• Temple, Texas, United States
• Fairfax, Virginia, United States
• Puyallup, Washington, United States
• Seattle, Washington, United States
• Charles Town, West Virginia, United States
• Port Macquarie, New South Wales, Australia
• Sydney, New South Wales, Australia
• Cairns, Queensland, Australia
• Box Hill, Victoria, Australia
• Frankston, Victoria, Australia
• Brussels, Bruxelles-Capitale, Region de, Belgium
• + 145 more on CT.gov