DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr (NCT04106115) | Clinical Trial Compass
RecruitingPhase 1/2
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
United Kingdom52 participantsStarted 2022-03-25
Plain-language summary
DURANCE is a two part, phase Ib/II, multi-centre study to assess the safety and activity of S-488210/S-488211 in combination with durvalumab, in patients with non-muscle invasive bladder cancer (NMIBC).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically proven high risk non-muscle invasive bladder cancer (NMIBC)
. Adequate archival tissue sample available for histological assessment (date sample taken must be within 6 months of planned start of treatment)
. Predominant histologic component (\> 50%) must be urothelial (transitional cell) carcinoma
. Bacillus Calmette-Guerin (BCG) unresponsive disease or are intolerant of BCG therapy
. Refused or deemed clinically inappropriate for radical cystectomy
. ≥18 years of age
. Body weight \>30 kg
. World Health Organisation (WHO) performance status 0-1
Exclusion criteria
. Any history of autoimmune or inflammatory disease including (any patients with a history of an autoimmune condition but without active disease in the last 5 years may be included only after consultation with the CI/TMG):
. Patients with prior allogeneic stem cell or solid organ transplantation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Dose Limiting Toxicity (Phase 1b)
Timeframe: At the end of cycle 1 (cycle 1 is 28 days)
2
Pathological Disease Free Survival Rate (DFSR) (Phase 2) from cystoscopy and mapping biopsies
. Patients who have had prior treatment with anti- PD-1, PD-L1 or CTLA-4 monoclonal antibody or other novel immune-oncology agent(s)
. Active invasive malignancy in the previous 2 years excluding non-melanoma skin cancer
. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia) or evidence of active pneumonitis on screening chest CT scan (history of radiation pneumonitis in the radiation field is permitted)
. Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
. QTcF value of \>470 ms. If prolonged, this should be confirmed by 2 further ECGs each separated by at least 5 minutes.
. Patients with the following risk factors for bowel perforation: