Muscle-invasive Urothelial CarcinomaPhase 2IMCODE004NCT06534983
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)
A Phase 2 study testing Autogene Cevumeran and Nivolumab in people with Muscle-invasive Urothelial Carcinoma, run by Hoffmann-La Roche at 38 sites in 15 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-invasive Urothelial Carcinoma
- What is being tested?
- Autogene Cevumeran and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 38 sitesin 15 countries
- Study dates
- 9 Dec 2024to 10 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have the capacity to participate/enroll in the study and to provide informed consent
- Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma [TCC]) of the bladder or upper urinary tract
- Tumor-node-metastasis (TNM ) classification (Union for International Cancer Control [UICC]/American Joint Committee on Cancer [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 received neoadjuvant chemotherapy (NAC), including antibody drug-conjugate, either alone or in combination with a checkpoint inhibitor (CPI), are eligible
- Participants who have not received any prior NAC are also eligible, provided they meet one of the following criteria, which would make them ineligible to receive adjuvant cisplatin-based therapy: participant refusal, cisplatin ineligibility or investigator decision
Show all 14Show fewer
- 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 human immunodeficiency virus (HIV) test at screening
- Negative hepatitis B surface antigen (HbsAg) test at screening
- Positive hepatitis B surface antibody (HBsAb), or a negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 500 international units/milliliter (IU/mL)
- Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening
Who cannot join
- 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
- Adjuvant chemotherapy, immunotherapy, or radiation therapy for UC following surgical resection
- Prior active malignancies within 3 years prior to randomization
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
Trial locations and contacts
38 sites in 15 countries.
38 sites in 15 countries
United States7 sites
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, 07920
MSK Commack
Commack, New York, 11725
MSK Westchester
Harrison, New York, 10604
MSK Monmouth
Middletown, New Jersey, 07748
MSK Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
MSK Nassau
Uniondale, New York, 11553
Spain5 sites
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Clinico San Carlos
Madrid, 28040
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Sant Andreu de la Barca, Barcelona, 08740
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Germany4 sites
Vivantes Klinikum Am Urban
Berlin, 10967
Uniklinikum Heidelberg
Heidelberg, 69120
Marien Hospital Herne
Herne, 44625
Klinikum Stuttgart - Katharinenhospital
Stuttgart, 70174
Italy4 sites
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari, Apulia, 70124
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Piedmont, 10043
IFO - Istituto Regina Elena
Rome, Lazio, 00144
A.O.U di Verona Policlinico G.B. Rossi
Verona, Veneto, 37134
South Korea4 sites
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Denmark3 sites
Aalborg Universitetshospital
Aalborg, 9000
Aarhus Universitetshospital
Aarhus N, 8200
Herlev Hospital
Herlev, 2730
Canada2 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Center
Montreal, Quebec, H4A 3J1
Poland2 sites
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, 85-796
AIDPORT Sp. z o. o.
Skórzewo, 60-185
United Kingdom1 site
Barts & London School of Med;Medical Oncology
London, EC1M 6BQ
About this study
Official 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
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.
- Conditions
- Muscle-invasive Urothelial Carcinoma
- Being tested
- Autogene Cevumeran, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogene CevumeranDrug
Also called RO7198457
Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm.
NivolumabDrug
Also called Opdivo
Nivolumab will be administered as an IV infusion per the schedule specified in the arm.
| Study group | Role | What they receive |
|---|---|---|
| Autogene Cevumeran + Nivolumab | Experimental | Participants will receive autogene cevumeran along with nivolumab intravenously (IV) at a recommended dose at specified timepoints. Receives: Drug: Autogene Cevumeran; Drug: Nivolumab |
| Nivolumab | Active comparator | Participants will receive 480 milligrams (mg) of nivolumab, IV, once every 4 weeks (Q4W) for 1 year. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: Up to approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start9 Dec 2024
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-invasive Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534983
- Sponsor's protocol ID
- BO45230
- Other IDs
- 2023-509023-40-00, 2023
- Acronym
- IMCODE004
- Status last verified
- Nov 2026
- First submitted
- 30 Jul 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06534983
- Acronym / sponsor ID
- IMCODE004 / BO45230
- Conditions
- Muscle-invasive Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogene Cevumeran + Nivolumab | Experimental | Drug: Autogene Cevumeran, Drug: NivolumabParticipants will receive autogene cevumeran along with nivolumab intravenously (IV) at a recommended dose at specified timepoints. |
| Nivolumab | Active comparator | Drug: NivolumabParticipants will receive 480 milligrams (mg) of nivolumab, IV, once every 4 weeks (Q4W) for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants must have the capacity to participate/enroll in the study and to provide informed consent
- Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma [TCC]) of the bladder or upper urinary tract
- Tumor-node-metastasis (TNM ) classification (Union for International Cancer Control [UICC]/American Joint Committee on Cancer [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 received neoadjuvant chemotherapy (NAC), including antibody drug-conjugate, either alone or in combination with a checkpoint inhibitor (CPI), are eligible
Key exclusion criteria (5 listed)
- 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
- Adjuvant chemotherapy, immunotherapy, or radiation therapy for UC following surgical resection
- Prior active malignancies within 3 years prior to randomization
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autogene CevumeranAlso: RO7198457Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm. | Drug | Autogene Cevumeran + Nivolumab |
| NivolumabAlso: OpdivoNivolumab will be administered as an IV infusion per the schedule specified in the arm. | Drug | Autogene Cevumeran + Nivolumab, Nivolumab |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
38 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autogene Cevumeran and Nivolumab in people with Muscle-invasive Urothelial Carcinoma, run by Hoffmann-La Roche at 38 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Spain, Germany, Italy, South Korea and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Up to approximately 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.