At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Autogene Cevumeran (drug), Nivolumab (drug)
- How long the study runs
- Study runs about 35 months (dates as stated)
- About the drug or intervention
- 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 62
- Started
- 2024-12-09
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for muscle-invasive urothelial carcinoma
- • Phase2 - 62 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with muscle-invasive urothelial carcinoma
Where?
- • Exeter - Royal Devon and Exeter Hospital
- • London - Barts & London School of Med;Medical Oncology
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ the capacity to participate/enroll in the study and to provide informed consent
What the study is looking for
- ✓Participants must have the capacity to participate/enroll in the study and to provide agreement to take part
- ✓confirmed by a biopsy muscle-invasive UC (also termed transitional cell carcinoma \[TCC\]) of the bladder or...
- ✓Surgical resection of MIUC of the bladder or upper tract
- ✓Participants who have received before surgery drug treatment (NAC), including antibody drug-conjugate, either alone or in...
- ✓Tumor tissue must be provided for test result analysis
Who cannot take part
- ✗Partial cystectomy in the setting of bladder cancer primary tumor or partial nephroureterectomy in the setting of...
- ✗Any approved anti-cancer therapy, including drug treatment, or hormonal therapy within 3 weeks prior to initiation of...
- ✗after surgery drug treatment, treatment that helps your immune system fight cancer, or radiotherapy 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
See the full criteria
Where Is This Study? (2 UK sites)
Royal Devon and Exeter Hospital
Exeter EX2 5DW, United Kingdom
Barts & London School of Med;Medical Oncology
London EC1M 6BQ, United Kingdom
