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) (IMCODE004)

Roche

Status and phase: Enrolling; Phase 2

Conditions: Muscle Invasive Urothelial Carcinoma

Treatments: Drug: Autogene Cevumeran; Drug: Nivolumab; Drug: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT06534983

BO45230

Details and patient eligibility

About

The main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC.

In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomization in either autogene cevumeran + nivolumab or the saline + nivolumab arm.

Enrollment: 362 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed muscle-invasive UC (also termed TCC) of the bladder or upper urinary tract
• TNM classification (UICC/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 not received prior neoadjuvant cisplatin chemotherapy (NAC) must be ineligible to receive adjuvant cisplatin therapy due to patient 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 HIV test at screening
• No evidence of active hepatitis B, defined as having a negative hepatitis B surface antigen (HbsAg) test at screening
• Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV 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
• Any prior neoadjuvant immunotherapy
• Adjuvant chemotherapy or radiation therapy for UC following surgical resection
• Malignancies other than UC within 5 years prior to randomization
• Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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362 participants in 2 patient groups

Autogene Cevumeran + Nivolumab

Experimental group

Description:

Participants will receive autogene cevumeran along with nivolumab intravenously (IV) at a recommended dose at specified timepoints.

Treatment:

Drug: Nivolumab

Drug: Autogene Cevumeran

Saline+Nivolumab

Active Comparator group

Description:

Participants will receive saline solution along with 480 milligrams (mg) of nivolumab, IV, once every 4 weeks (Q4W) for 1 year.

Treatment:

Drug: Saline

Drug: Nivolumab