Brief Title: Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants With Adverse Events (AEs)

Primary Outcome 1 - Timeframe: Up to approximately 15 months

CONDITION

• Muscle-invasive Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
* Participants must have the capacity to participate/enroll in the study and to provide informed consent

- * Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma [TCC]) of the bladder or upper urinary tract

- * Tumor-node-metastasis (TNM ) classification (Union for International Cancer Control [UICC]/American Joint Committee on Cancer [AJCC] 7th edition) at pathological examination of surgical resection specimen of (y)pT3-4 or (y)pN+ and M0

- * Surgical resection of MIUC of the bladder or upper tract

- * Participants who have received neoadjuvant chemotherapy (NAC), including antibody drug-conjugate, either alone or in combination with a checkpoint inhibitor (CPI), are eligible

- * Participants who have not received any prior NAC are also eligible, provided they meet one of the following criteria, which would make them ineligible to receive adjuvant cisplatin-based therapy: participant refusal, cisplatin ineligibility or investigator decision

- * Tumor tissue must be provided for biomarker analysis

- * Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization

- * Full recovery from cystectomy or nephroureterectomy within 120 days following surgery

- * Eastern cooperative oncology group (ECOG) performance status of 0 or 1

- * Negative human immunodeficiency virus (HIV) test at screening

- * Negative hepatitis B surface antigen (HbsAg) test at screening

- * Positive hepatitis B surface antibody (HBsAb), or a negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 500 international units/milliliter (IU/mL) - * Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening
Exclusion Criteria:
* Partial cystectomy in the setting of bladder cancer primary tumor or partial nephroureterectomy in the setting of renal pelvis primary tumor

- * Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment

- * Adjuvant chemotherapy, immunotherapy, or radiation therapy for UC following surgical resection

- * Prior active malignancies within 3 years prior to randomization

- * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Clinical Trials

Role: Study Director

Affiliation: Hoffmann-La Roche

Overall Contact

Name: Reference Study ID Number: BO45230 https://forpatients.roche.com/, Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Phone: 888-662-6728 (U.S. Only)

Email: [email protected]

LOCATION