BO45230 - IMcode004 (JCP166)

A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC)

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Population: Muscle-Invasive Urothelial Carcinoma

Line of therapy: Adjuvant

Intervention: Autogene cevumeran/saline + Nivolumab

Key Inclusion Criteria

1. Histologically confirmed muscle-invasive UC (also termed TCC) of the bladder or upper urinary tract

2. TNM classification (7th edition) at pathological examination of surgical resection specimen of (y)pT3-4 or (y)pN+ and M0

3. Surgical resection of MIUC of the bladder or upper tract

4. have not received prior neoadjuvant cisplatin chemotherapy (NAC) must be ineligible to receive adjuvant cisplatin therapy due to patient refusal, cisplatin ineligibility or investigator decision

5. Tumor tissue must be provided for biomarker analysis

6. Absence of residual disease and absence of metastasis, as confirmed by a negative baseline CT or MRI scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization.

7. Full recovery from cystectomy or nephroureterectomy within 120 days following surgery

8. ECOG performance status of 0 or 1

9. Negative HIV test at screening

10. No evidence of active hepatitis B, defined as having a negative hepatitis B surface antigen (HbsAg) test at screening

11. Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening

    
    

Key Exclusion Criteria

1. Partial cystectomy in the setting of bladder cancer primary tumor or partial nephroureterectomy in the setting of renal pelvis primary tumor

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

3. Any prior neoadjuvant immunotherapy

4. Adjuvant chemotherapy or radiation therapy for UC following surgical resection

5. Malignancies other than UC within 5 years prior to randomization

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

Sponsor: Roche

CRP Contact: hend.al-bizri@ladydavis.ca

CRP PI: Dr. C. Ferrario

Status: Open to accrual