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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
5/11/2024

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2024
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; Clinical Trials Unit - Elizabeth Vale
Recruitment hospital [2] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Germany
State/province [3] 0 0
Heidelberg
Country [4] 0 0
Italy
State/province [4] 0 0
Lazio
Country [5] 0 0
Italy
State/province [5] 0 0
Veneto

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
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.
Trial website
https://clinicaltrials.gov/study/NCT06534983
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06534983