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)

Conditions

• Muscle-invasive Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Autogene Cevumeran — DRUG
  Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm.
• Nivolumab — DRUG
  Nivolumab will be administered as an IV infusion per the schedule specified in the arm.

Study Details

The original purpose of this study was 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 randomized in either autogene cevumeran + nivolumab or the nivolumab monotherapy arm. Following the Sponsor's decision to phase out the study, as of Protocol Version 5, the primary purpose of the study is to ensure treatment continuity and safety for the participants who continue to participate in the study and receive study treatment.

Key Dates

Start date

Dec 9, 2024

Status verified

Jun 2026

Primary completion

Nov 10, 2027

Completion

Nov 10, 2027

Study Design

Enrollment

62 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Autogene Cevumeran + Nivolumab
  Participants will receive autogene cevumeran along with nivolumab intravenously (IV) at a recommended dose at specified timepoints.
• Active Comparator: Nivolumab
  Participants will receive 480 milligrams (mg) of nivolumab, IV, once every 4 weeks (Q4W) for 1 year.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 15 months ]

Central Contacts

• Reference Study ID Number: BO45230 https://forpatients.roche.com/
  888-662-6728 (U.S. Only)
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (26)

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