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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06534983




Registration number
NCT06534983
Ethics application status
Date submitted
30/07/2024
Date registered
2/08/2024
Date last updated
4/07/2025

Titles & IDs
Public title
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)
Scientific title
A Randomized Phase II, Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of Autogene Cevumeran Plus Nivolumab Versus Nivolumab as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma
Secondary ID [1] 0 0
BO45230
Universal Trial Number (UTN)
Trial acronym
IMCODE004
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Invasive Urothelial Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Autogene Cevumeran
Treatment: Drugs - Nivolumab
Treatment: Drugs - Saline

Experimental: Autogene Cevumeran + Nivolumab - Participants will receive autogene cevumeran along with nivolumab intravenously (IV) at a recommended dose at specified timepoints.

Active comparator: Saline+Nivolumab - Participants will receive saline solution along with 480 milligrams (mg) of nivolumab, IV, once every 4 weeks (Q4W) for 1 year.


Treatment: Drugs: Autogene Cevumeran
Autogene cevumeran will be administered as an IV infusion per the schedule in the specified arm.

Treatment: Drugs: Nivolumab
Nivolumab will be administered as an IV infusion per the schedule in the specified arm.

Treatment: Drugs: Saline
Saline solution for intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator Assessed Disease Free Survival (INV-DFS)
Timepoint [1] 0 0
Randomization until the first recurrence of disease or death from any cause, whichever occurs first (approximately 6 years )
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization until the date of death from any cause (approximately 6 years)
Secondary outcome [2] 0 0
Investigator Assesed DFS in Programmed Death Ligand-1 (PD-L1) Expression = 1% Population
Timepoint [2] 0 0
Randomization until first occurrence of a documented disease recurrence or death from any cause, whichever occurs first (approximately 6 years)
Secondary outcome [3] 0 0
Investigator Assessed Distant Metastasis-Free Survival (DMFS)
Timepoint [3] 0 0
Randomization to the date of diagnosis of distant (i.e., non-locoregional) metastases (approximately 6 years)
Secondary outcome [4] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [4] 0 0
Up to approximately 22 months
Secondary outcome [5] 0 0
Change From Baseline in Participant-reported Pain, Physical Function, Role Function and Quality of Life (QoL) as Assessed Using European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [5] 0 0
From Day 1 up to approximately 25 months
Secondary outcome [6] 0 0
Number of Participants With Symptomatic Treatment Toxicities as Assessed by National Cancer Institute Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
Timepoint [6] 0 0
From Day 1 up to Cycle 21 (cycle length=28 days)
Secondary outcome [7] 0 0
Number of Participants Experiencing AE Burden due to Treatment as Assessed by EORTC Item Library 46 (IL46)
Timepoint [7] 0 0
From Day 8 up to Cycle 21 (cycle length=28 days)
Secondary outcome [8] 0 0
Change from Baseline in Symptomatic Treatment Toxicities as Assessed by National Cancer Institute Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
Timepoint [8] 0 0
From Day 1 up to Cycle 21 (cycle length=28 days)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/01/2034
Actual
Sample size
Target
362
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
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United States of America
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District of Columbia
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United States of America
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Kentucky
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Namur
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Canada
State/province [19] 0 0
Alberta
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Aalborg
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Denmark
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Aarhus N
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Denmark
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Herlev
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France
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Lille
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France
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Rennes
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Germany
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Berlin
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Germany
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Düsseldorf
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Jena
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Germany
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München
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Germany
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Ulm
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Greece
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Athens
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Greece
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Thessaloniki
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Puglia
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Italy
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Veneto
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Norway
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Lørenskog
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Poland
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Bydgoszcz
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Poland
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Koszalin
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Poland
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Lublin
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Olsztyn
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Radom
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Poland
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Skórzewo
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Islas Baleares
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Spain
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LA Coruna
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Göteborg
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Sweden
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Lund
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Taiwan
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Kaohisung
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Taiwan
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Taipei City
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taipei
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Exeter
Country [71] 0 0
United Kingdom
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London
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United Kingdom
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Preston
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
BioNTech SE
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO45230 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06534983